Transcripts For CSPAN Baby Formula Manufacturers FDA Commissioner Testify On Shortage 20240707

>> subcommittee seeks answers on how families across the country have faced empty shelves during this infant formula shortage. we expect answers from the fda, abbott, and the other two leading formula manufacturers on why caregivers are scrambling to find the necessary nutrition they need to sustain their babies and children. most importantly, we will discuss solutions to prevent this from ever happening again in the future. the current formula shortage has real consequences. babies and children are suffering. parents are nervous wrecks trying to this. i have heard stories from partitions -- from pediatricians trying to get nourishment for their children. i have spoken to parents who have driven from store to store to find formula. i have heard from children's hospitals who are seeing an increase in patients because caregivers have not been able to secure the formula they need. we know this has a disk portion it -- a disproportionate impact on of income families and families that rely on special formulas for children with special needs. these are our top priorities in today's hearing. the tragic situation is unacceptable and was totally preventable. there were growing strains in the months leading up to illness, but the recall itself turned the formula surprise into a tailspin. abbott is not blameless. the company appears to have neglected essential manufacturing and cleaning processes that are in place to guarantee the safety and reliability of products needed for our most vulnerable populations. today, the batch of contaminated infant formula that sickened four infants resulted in two of their deaths. the bacterial sample strain of the sample taken from two of the four infants was not found in environment of samples taken from abbott's production facility. alarmingly, the facility has too long of a record of deficiencies, including evidence of the same bacteria on site and batches of its formula in 2019 and leading up to the 2021 inspection. fortunately, some batches were caught. this presents a disturbing pattern of negligence. one company alone does not bear the entire burden for lending in this current situation. there are questions surrounding the timeline of fda's investigation response from a four-month lapse from returning to inspect the facility, delayed connection with a whistleblower, and slow communication to the american people. there is much more to learn about fda's actions. we see clarity on what the agency was doing behind the scenes during this critical time period and what lessons have been learned from the situation. i am pleased the fda and administration have been focused on solutions, announcing a range of actions across the federal government to increase formula for companies in the most special need. as manufacturers are in the midst of these productions, maximizing productions to meet the urgency of the moment. we are also joined by the other two major manufacturers of infant formula in the u.s., gerber and reckitt. these companies have been ramping up production and bringing safe formula into the supply stream to fill gaps. the biden administration's efforts to coordinate this response to get families out of the immediate crisis have been extensive and i think we will see they are working soon. we cannot ignore the need for longer-term solutions. the bottom line is that the fda needs the resources to make sure the food part of food and drug administration is not an afterthought. just as fda works to ensure that life-saving medicines are safe and effective, the agency must have resources and staffing to ensure the food consumers consume is safe and reliable. fda's food safety oversight is resourced at only half the amount of drugs and biologics. as a member of the subcommittee for decades, i will tell you this is not a new problem. it has been under resource for far too long. i am pleased that the house passed funding to address the current emergency. a one-time fix is not enough to build a more resilient safety for the future. we have to work together to bolster the supply chain system not just today but for our children tomorrow. the empty cells -- the empty shelves are inexcusable and the stories of caregivers scrambling to find nutrients their children want and need are heart-wrenching. i stand with our colleagues and witnesses today in committing to find solutions, permanent solutions, with the american public. at this time, i am proud to recognize the ranking member, mr. griffith, for the opening statement. rep. griffith: thank you for holding this critically important hearing. i want to thank the commissioner personally for coming to this hearing and responding to a phone call the fda arranged. at the hearing last week, commissioner califf said he would be prepared to go into much more details today at our oversight hearing. i look forward to learning those details. many infants in the u.s. rely on formula for nutrition and parents are experiencing anxiety as the country faces an infant formula shortage. no parent should have to worry about how they're going to feed their baby. i've heard from folks all over southwest virginia who are having issues providing the most basic need for their infants. the big question is why did the biden administration let shortage become so dire without acting with urgency? i anticipate we with your different excuses today and i'm not interested in debating whether babies can switch from one branch to another. i'm looking for answers and long-term plans moving forward so this doesn't happen again. how did we get here and when did this shortage begin? the fda says it has been on their radar since march 2020. hhs secretary said the committee has been keeping him aware of the situation since last year. when asked if moore could have been done sooner, white house press secretary said hindsight is always 20/20. in response to criticism that the white house was too slow to respond, president biden told supporters if we had been better mind-readers, i guess we could have but we moved as quickly as the problem became apparent to us. so which is it? was the administration aware shortage was developing for over two years and failed to take action? or were they caught flat-footed? or as i believe, both. no matter the reason, it is not acceptable. suffice to say i have a lot of questions for our fda witnesses. with all of the stresses on infant formula, including disruptions in the supply chain and consumer stockpiling, the availability of formula on shelves was already strained before abbott closed their sturgis, michigan facility. where was the biden administration plan to deal with what should have been a foreseeable event? we did not see a plan on february 17 or 18th or march 1 or even in april. in fact, the fda did not conclude its follow-up inspection until march 18. it was not apparent until mid-may that the right and administration took this seriously and began to act. why did it take any onslaught of national media attention for the biden administration to act with agency -- urgency required to address an infant formula shortage? abbott submitted their response following the inspection on april 8. not until may 16 did the fda working with the department of justice issue a consent decree. i don't understand how the fda can justify three-months to respond to this crisis. i expect to learn why the fda did not move heaven and earth in an attempt to get the sturgis plant back up and running as soon as possible. folks, february to june is not acceptable to the american families and american parents don't consider that working as soon as possible. i also have questions for the infant formula manufacturers because they have a role in this crisis as well, including what can be done to increase supply and what will be done to prevent something like this from ever happening again. i have questions for abbott about the events that led to be shutting down of the sturgis plant. i hope to hear about the status of the plant and abbott's efforts to reopen the plant. being a parent rings an incredible amount of joy -- brings an incredible amount of joy, excitement, and love. but it can also be an incredibly frightening time for parents. parents should not worry about how or if they will feed their baby. the ability to provide nutrition for a young infant cannot be ignored. more must be done to prevent future shortages. statements like if we had been better mind-readers, we could have acted more quickly, those do not inspire confidence. the american people deserve answers. i look forward to discovering how to address this ongoing crisis. i thank they witnesses for being here and being part of this discussion. ideal back. rep. degette: the china recognizes the chairman of the -- committee for five minutes. >> thank you for organizing this hearing quickly. today, parents and caregivers are seeing empty store shelves, astronomical prices online, or having to drive hours for the formula they need to feed their children. this hearing will understand -- will seek to understand how this occurred, how to address it, and how we can prevent it from happening again. our solutions will include the distillation -- include legislation and -- the data on the extent of the shortage based on where a family lives or whether a child needs a specialty formula or a specific type or brand, so some regions have been hit harder than others. disturbingly, low income women and children who rely on the wic program have been particularly impacted. the shortage begin to rise after strains on the supply chain. there's no question -- the impact from just one infant formula plant closing in the u.s. shows the power one single manufacturer has two influence the nation's supply of formula when three companies control 95% of the market. we are too reliant on too few companies to do the right thing. when one company cuts corners, we spiraled into emergency. there needs to be more competition so these manufacturers don't have a monopoly. this committee will examine the circumstances surrounding the recall and shutdown. we will all go -- we will also ask about the sturgis facility and the timeline of actions to address safety risks. we also have to address the current shortages and address future supply strains about the supply shortages they face and the challenges and steps they take to increase the availability of safe infant formula. the fda officials and executives need to answer some tough questions. abie's lives are at stake and they american people demand answers and solutions. fortunately, the biden administration has taken responsive action to increase the supply of formula for american families. it worked with manufacturers to increase production and encouraged importation of safe infant formula. the president also launched operations to increase to mystic reduction and bring safe imported formula to store shelves. the fda has also eased import restrictions for hundred 80 days to allow international manufacturers to help address the shortage while ensuring formula meets our national safe and nutrition standards. congress has already taken swift action, too legislation which the president signed on saturday into law which grants flexibility to the wic program to increase the supply of formula available to families. the house passed the infant formula appropriation act providing the fda with resources to resolve the current baby formula shortage and lay the foundation to make sure this never happens again. we have to do more. fda's food safety efforts have been underfunded, under resourced, and understaffed. this committee took a step to address that by advancing an fda bill that will strengthen its ability to recruit and retain highly qualified staff across the agency, including areas overseeing baby formula and baby food. that bill will head to the floor in coming weeks. additional legislation will be necessary to improve transparency and requirements and empower the fda to set limits more on contamination. they must do as part to ensure robust controls being followed to prevent contamination products from reaching a single child. put simply, it should not take the direct intervention of the fda and the president to keep infant formula on the shelf. the manufacturers have to take responsibility. we must all work together to guarantee the safety and supply of baby formula to ensure the health of our nation's children. the energy and commerce committee will act as always, on a bipartisan basis, to enact necessary legislation. this committee hearing is important. it will lay the groundwork for what we have to do legislatively. i want to besides that. thank you, madam chair. thank you for doing so many things of an oversight nature with this subcommittee. i yield back. rep. degette: the chair is pleased to recognize the ranking member of the -- committee for five minutes. >> before i begin, i want to address the school shooting in texas. this morning, i took my kids off to school and i never thought about the possibility about it being the last time i would see them. school is about making friends and being kids. i know you're anxious to get the information, we want answers of what would put someone in a place to take young innocent lives. there is a sense people are struggling, crime and violence is going up. there is a mental health crisis. these are the conversations we must have together and i hope that we will to help end this despair and bring hope to our communities again. regarding today's hearing and the point i baby formula shortages, parents should not have to drive hours paying record high gas prices, visiting multiple stores to find formula after midnight to finally see their children two or three days more. that is the reality of the crisis in america today, putting newborns and babies in the hospital. there are parents are unsure if they will be able to feed their baby. they need support and meaningful action to increase supply. they also demand answers. including the failure by fda and the administration not acting soon enough. the biden administration said it did not anticipate the formula shortage. it should have as part of the pandemic response, ft had a data and analytics tool to monitor the supply chains of race products, including infant formula. the food city center was in contact with the infant formula industry to monitor ingredients and other components for production and maintain a healthy and safe supply. a january wall street article, a month before the abbott plant closed -- found to recall formula. they just had to read their own data and listen to parents. with abbott being a major supplier and given the information at its disposal, the fda should have known the plant closure would have made the shortage even worse. this is not the first time fda has been confronted with looming supply crisis. in 2004, the flu vaccine supply was provided by only two manufacturers. one, a british company, shutdown after fda inspectors found safety problems. that meant just before the flu season half of the u.s. flu supply -- flu vaccine supply was gone. the administration medially took action to secure doses of other manufacturers and encourage manufacturers to seek licensure from the fda. when abbott's plant closed, the biden administration should have acted with urgency to increase supply on day one. the fda did not act decisively until parents forced them to move publicly. the fda failed to respond properly to the warning signs. in september 2021, fda conducted an inspection and issued a report that found hazardous food safety practices. around the same time, fda received four complaints about infections in infants. two of the babies died. all have been reportedly consumed abbott nutrition product though a link has yet to be established. in october 20 21, the fda received a complaint about the sturgis plant from an ex employee who alleged data falsification and release of untested products. there was a life and death crisis in front of fda but they failed to see the severity of these situations. the fda did not interview the whistleblower until months later and did not inspect the plant until january 2022. fda did not even form an incident management group on infant formula until april 1, 2022, more than six months after it found issues. this hearing is any opportunity to assure parents are certain the fda does not repeat mistakes that led to these shortages. i am leaning on legislation to increase and restock empty shelves. it also requires more oversight and accountability to ensure the fda is doing his job at acting quickly. we must solve the issue and making sure we are taking actions so this situation never happens again. i thank you and you'll back -- and yield back. rep. degette: the chair asks unanimous consent that opening statements be made part of the record and without objection so ordered. i want to introduce our first panel of witnesses. dr. robert califf, the administrator of the food and drug administration. the deputy commissioner for food policy and responsiveness, and dr. susan may, the director of the center of food safety and applied administration -- and applied nutrition of the fda. i know you are aware the committee is holding an investigative hearing and when we do so we have the practice of taking our testimony under oath. does any of you have any objection to testifying under oath? >> no objection. rep. degette: let the record reflect that the witness responded no. under the rules of the committee, you are entitled to be accompanied by counsel. do any of you wish to be accompanied by counsel. >> no. rep. degette: witnesses have responded no. please raise your right hand so you may be sworn in. do you swear that the testimony you are about to give is the truth, the cold truth, and nothing to the truth -- nothing but the truth? >> yes. rep. degette: they witnesses have responded affirmatively and you are not under oath and subject of penalty set forth in the u.s. code. the chair is pleased to recognize commissioner caleb -- commissioner robert califf for 10 minute opening statement on behalf of all of our fda witnesses. i want to note there is a timer on the screen, you can see it, that counts down your remaining time. i want to thank you for appearing and recognize you for 10 minutes. mr. califf: thank you madam chairwoman. thank you for inviting us to testify. and she -- ensuring that infant formula is safe and nutritious is a important job of the food. we are fully aware that many parents and caregivers have been unable to access the formula product they need. many of us are parents and grandparents, too, and we want to express our super before parents and caregivers experiencing difficulty and stress as they attempt to find formula. i have been driven by memories of the month my daughter spent in the intensive care unit as an infant and the deep concern and anxiety of a parent to protect any innocent child. we have provided you with a written testimony describes the history of the problem and gives a detailed timeline during this hearing, i welcome reference to this document. on september 20, 2021, fda learned of an infection in an infant who consumed formula produced at abbott's nutrition -- abbott nutrition's facility. the timeline specify the chain of events, and ate it in a four because on-site inspection of the sturgis facility on january 31, 2022. while there are many stops along the way for different actions, to this date i can find no evidence of intentional delay or malfeasance. we have the facts delineated at this point. after action review, improvements to prevent delays like this in the future and to improve our decision-making. i've asked dr. steven solomon, director of our center of veterinary medicine, to lead this review. before leaving the center, he served in the office of regulatory affairs and has organizational knowledge of the food program as well as compliance and enforcement. the fda and cdc investigations cannot conclude that the unsanitary conditions in the abbott facility caused the illnesses reported. however, we cannot rule it out. the consequence of events is unusual. there is no dispute that the facility was unsanitary. the results were shocking. standing water, cracks and achy equipment that presents the potential for bacteria infection to exist, particularly in the presence of moisture, leaks in the roof, inadequate handwashing, and -- sent tatian. bacteria growing for multiple sites and a disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people. as a clinician, i have used life-saving drugs and diagnostic tests and cardiovascular devices made by abbott. this is so far removed from our previous experience with the company that i am very concerned as soon as we received positive results from environmental samples we collected during the inspection, we contacted abbott to issue a voluntary recall. they need to protect the most vulnerable of all of our infants presented a dilemma. this is the largest manufacturer and the sole source of metabolic formulas essential for the viability of infants. with no substitution possible, because abbott had no backup plan. we knew that seizing operations would create supply problems but we had no choice given the unsanitary conditions. we took several critical steps within hours, including reaching with those who had been dealing with our supply chain throughout the pandemic. in memo was sent to agencies showing the risk. products were made available on a case-by-case basis, consulting with pediatricians and safety experts. -- increasing production to supply the market. we asked retailers to place limits on how much anyone person could buy to minimize access buying. we remain infrequent education -- medication with our partners about the status and risk. because of the diversification of this market and the lack of a central hub, we concluded getting the sturgis facility running was a top priority. we had no confidence in the integrity of the abbott quality program. we initiated proceedings towards a consent which allows abbott to ensure safe production on formula, including hiring an outside expert. our oversight is critical, but make no mistake, the return from normal will only occur when abbott resumes production in a safe manner. as details in charts included in the testimony, -- the stocking of formula and the rate of consumption along. sales of infant formula have remained steady and in fact volume and quantity of formula purchased our 5% to 50% higher now than in the months -- 52 -- 5% to 15% higher than in months before the recall. we knew that distribution was an issue. some areas where excreting shortages, but overall there was enough formula to go around. about one month ago, the reports of shortages proliferated. there was not a drop in production. this increase presents heightened concern for parents and caregivers about shortages leading to an understandable effort to ensure etiquette supply at home. this cycle has happened with other products throughout the pandemic. we realize the only solution is to have adequate supply to make sure shelves are stocked. to that end, we have employed measures to increase supply. including an agreement that will allow sturgis plant to get back in production mode. i met with the abbott ceo and he assured me they will be ready to go in early june. we continue to work with manufacturers to increase production and distribution. i commend them for their efforts and we have seen substantial increases. we are helping with the all of government response and support importation of products not currently in the u.s. market by using case-by-case easing of regulatory requirements to increase the number of many factors allowed to import formula. working with state health commissioners to increase availability of wic and issue additional suppliers to enter the market and eliminate price counters. -- price gougers. we have worked to manage the complex issues encountered by those with infants with metabolic issues requiring special formula. i will leave you with several thoughts. fda's timeliness of interviewing the whistleblower and getting into the facility for a four because inspection were too slow and some decisions could have been more optimal. i did not return to fda to preside over business as usual. as many of you know, i was enjoying a good life in the abbott sector when asked -- in the private sector when asked to come back. i believe that success follows proper attention to structure and function, leadership and resources to support the work of employees. all of these issues need attention in the underfunded side of the fda. you will see changes in the near future. our request for funding and authority are essential in concert with improved operations and leadership. the return of the sturgis plant to safe production of formula is critical. abbott's marketshare share left it with responsibility to produce safe infant formula that was not met. we will do everything to work with abbott to make this happen as quickly as possible. this time it -- this timing is in abbott's control. companies inside and outside of the u.s. has been heartening. while we wait for abbott to fulfill its responsibility -- [no audio] from a variety of sources. this did not happen overnight. across the industry we regulate, we are singing of just-in-time distribution system, market contribution of contracting leading to shortages. multiple calls for supply chain management until regulatory agencies have access to supply chain information and personnel to do the work, we will continue to react to supply chain reactions -- supply chain disruptions. we will not rest until our shelves are replete with safe and nutritious infant formula and i will work with the fda to promote the health and well-being of the american people, particularly our most vulnerable people. rep. degette: thank you so much, commissioner caleb. -- commissioner robert califf. i appreciate your commitment to try to fix it. i want to make sure we are on the same page and i want to go through the timeline presented in your written testimony. you referred to it, too. from september 20 through the 24th in 2021, fda did a routine inspection of the sturgis facility. coincidentally on the same date, september 20, fda got news about an infant who had become ill due to the bacteria after consuming infant formula reduced at sturgis facility. about a month later, fda got a complaint from a whistleblower about the lack of cleaning and testing facilities at sturgis as well as alleged falsification of records and deception of fda inspectors. that person was not interviewed until two months later in december. between december and february 2022, fda received three more consumer plan -- consumer complaints, two that resulted in death. despite all of this, fda did not return to inspect the sturgis facility until january 31. according to your testimony, there was a six-week inspection and there were fundamental sanitation and equipment issues. but then february, abbott closed down the plant at sturgis and ceased production. two days later, finally abbott voluntarily recalled the products. on march 18, fda closed inspection and issued its inspection observations to abbott. finally on may 16, fda and abbott consent decree reviving steps abbott needs to undertake. that was may 16. now abbott is telling me it will take two weeks to clean the plant and then take up to six to eight weeks to get back to full production. commissioner, this is what i am concerned about. i went through this timeline. by my count, it took about four months from when the agency first became aware of these reported cases to inspect the sturgis plant and then it took two more weeks for abbott to stop production and then took three months more for fda and abbott to enter into a consent decree. does that sound about right? mr. califf: that sounds right. it is all documented in your testimony. rep. degette: what all of us are concerned about, obviously, and the parents of america are concerned about, it could be up to a year between the first inspection in september last year and full production at this point. at the same time, the vulnerable infants and children are not getting their formula. i guess you refer to this that you have somebody looking into it. do you have any idea why it took so long from the report to inspection and recall? what is the plan to shorten the time in the future? mr. califf: you are right to be concerned and the public should be concerned. it was too slow and there were decisions that were sub optimal along the way. i'm sure you also know that as i was going through confirmation i got many calls from people concerned about the food because of the lack of resources and concerns about the organizational struck -- organizational structure. my plan has been to get to this crisis and then we will look at the food program on the perspective of reforming but not ready to deal with the specifics of this case. this is where dr. solomon who is a truth teller will lead an effort to a bus get the processes. rep. degette: i have been on the subcommittee for several decades and the food program of the fda -- we had the peanut butter crisis, we had many crises. we rushed to make that plant safe and clean it up. ultimately, we have to work together to put food back into food and drug administration. we have to not just throw money at it, we have to figure out what to do to make these inspections robust and shorten the time. would you agree with that? mr. califf: i would agree with that and applied what you did on the mechanical side. the food side it's a shot in the arm. rep. degette: we will work on it. thank you so much, i am pleased to recognize the ranking member mr. griffith for five minutes. rep. griffith: thank you so much. dr. califf, thank you for being here. i respect you for coming up to answer the tough questions. i know it is not what you intended but some could take the impression that in part you are the new moms and dads who were scared their children cannot be fed and they were over buying. the answer is not that moms and dads are responsible, it is the manufacturers. i think that is important. let me go to some follow-up questions. according to your written testimony, it was december 6 when you're team finally got together and the fta team got together to say we ought to have a plan to inspect the sturgis plant. the timeline attached to your written testimony says that the first time they got together they got together was october 21. when you have a problem identified in september, i am glad you have already agreed that getting to do an inspection january 31 is too late. you agree that is too slow, yes or no? dr. califf: yes. rep. griffith: i'm curious that your testimony said the fta first had concerns about formula production in march 2020. the situation was going to get worse with the facility -- the abbott facility which makes a large percentage of -- did the fda have an action plan to deal with one of the manufacturers shutting down and what were going to do when the kids did not have enough formula? did we have a plan on what action we would take? dr. califf: we had several committees doing things i mentioned which was contracting -- which is contacting the other members -- the other producers. they did ramp up to the extent that they could. rep. griffith: the question is, when you have one source in most states they can purchase, and a lot of times that is abbott, why did it take three months to say we are going to have a relaxation on some of these regulations when it comes to wick, a relaxation on some of these products coming from europe. where was the request for -- from us? where was the request to start flying in formula overseas? why was that not happening in march instead of mid day -- mid-may? dr. califf: can i refer to other colleagues or can answer the question? rep. degette: they can refer to them if they have the answer. dr. califf: we were monitoring this and the system seems to be keeping up with demand until there were shortages we were responding to. at the same time, we were trying to get the abbott plant up as quickly as we could. mr. yiannis may have an answer. rep. griffith: let me move to another question. i know you said you tried to get the plan up as soon as possible and i know you believe that. when you have an emergency situation like this, and i know you did some special things for the metabolic and kids who need special formulas, you tried to move on that quicker. when you have 11% to 12% of your total production going down, i wonder why it is taking so long to get where we are. why were we not working at breakneck speed? in the battle of midway, after being damaged at sea, general everett says we need to get this ship out. that ship was sailing in two days because the american soldier got in there and got it done. i don't think you could get sturgis open in two days but why would it take four or five months to get it open? wiring -- why were we not moving in march and getting the plant open then? rep. degette: you can answer briefly if you would like. dr. califf: with regard to the sturgis plant specifically, as i say, we did not have confidence they would produce safe formula until he got control of the plant through the consent decree. the consent decree is a legal agreement involving the department of justice and the manufacturer that has to be negotiated. i will also add, abbott started mediating the plan but it was so bad -- we met with them yesterday and there were some these steps in this sense -- even though they were working at since day one. they are still not ready to go but they will be in the next few weeks. rep. degette: the chair now recognizes chair powell loan -- chair pallone. rep. pallone: i want to talk about the current crisis. particularly legislatively since we are the organizing committee. i love the ranking member's war mentality because that is how this has to be right now, like a general in the field. the president has invoked the defense production act. you are taking actions with abbott. how is this going to couple at each other? will it be effective in getting this formula out quickly? you're talking two weeks, three weeks, whatever to get this shortage over with. as part of that, how would you get information distributed so we can tell our constituents how they get this formula, how they have access to it? two minutes. dr. califf: this is a war mentality, a crisis we are fully aware of. families should not be searching from her love but they have to do it now until we fill in. several weeks out, we will have a surplus of formula. i can say exactly how many weeks. until then, we have to fill in with these measures. other producers have stepped up and we are now importing and flying military planes and other planes to pick it up and bring it in. we just have to keep filling in until we get to the point production is up. rep. pallone: how about getting it out so that our constituents know how to get it? i am concerned you do all of this and they will not know how to access it and still have a problem, particularly low income people who don't have access to information. dr. califf: it is important for people to go to the hhs website, hhs.gov/formula. you will have helpful information about where to go. the distribution is be handling by professionals in the supply chain who have been working throughout the pandemic. as soon as it comes in, we will get it to the places that are in the greatest need. you are right, the public is going to have to stay attuned, hopefully through that website, to get information they need. rep. pallone: think of other ways because not everybody has -- let's think of other ways to get that information out. my second question, with the authorizing committee, i am concerned about a future crisis because we need to have a mechanism where the manufacturers tell us or it triggers an alarm bell for the fda if they are experiencing shortages for whatever reason. what i'm told is maybe we need some transparent legislation through reporting requirements that would require many to alert fda of shortages so they can shift production or we can go into overload. also, something to empower the fda to act more quickly in regards to contamination. that process is so bogged down and regulatory -- bogged down in regulatory ways. what can we do to have better reporting? what can we do so you don't get logged down in this long process whether it is potential contamination or any other tools you need? dr. califf: we have asked for a number of authorities and consistently -- just to remind the group of the -- of what is in the document. we requested authorities to deal with specifically infant formula shortages and we were not successful getting those acted upon. we did a number of things to try to deal with the resources we cobbled together. you mentioned things that are critical. right now, we have no ability -- there is no requirement manufacturers alert us if they are running short. secondly, for example, abbott had cultured bacteria in samples going back a ways, but since they not ship them out, they had no requirement to keep the samples were alert us. we discovered it on inspection. it may surprise people to know that. the consent decree process we can have a long discussion about. for me, or to google for five years before coming back. you would be surprised to know there is a system where all the fda's -- there is no system where all of the fda employees can see what is going on. we need access to the information any fractures have about each of their individual supply chains. they each have their individual supply chains but there is no system to make sure the supplies are getting where they need to go. right now, we have a shortage of contrast -- we have to do something about the supply chain. >> want to pick up where the chairman left. as a part of the pandemic response, the fda did not have the data tool to monitor the supply chain for various products, including infant formula? dr. califf: we requested funding for a tool and because we did not get the funding, we cobbled it together. it is a start but nowhere near. the technology at the fda and in many federal agencies is outmoded. rep. rodgers: i would like to understand more about that. congress authorized funding for an data analytics tool. fda was in contact to monitor ingredients and to maintain a safe supply. the slow response by fda to the infant formula crisis has created a situation for parents. months without any action has only contributed further to this life or death situation. it is expected that two babies now have died and others are critically ill from other contaminated formula and with that avid plant --abbott shutdown, it is presenting another health crisis, a lack of access to baby formula. there were four babies hospitalized in south carolina because of complications arising from baby for the -- formula disorders. we have a crisis because parents cannot get baby formula. have many -- how many reports does the fda have where the babies have gotten sick or worse related to the storage -- shortage of baby formula? dr. califf: it is not a not -- large number but each one is it significant and we have a committee of people -- i would like to refer this question to another doctor who spent countless hours working on this issue. >> we have been in discussion with infant 4 -- formula anti-vaxxers since cova. discussion is not the same thing as data and we do not have the dority to get all the information to monitor the this :00 -- supply change. rep. rodgers: right to know about the data analytics tool that congress authorized to fda to help with this specific situation. where the findings? -- what were the findings? dr. califf: i was not here when that decisions -- was made. based on everything that i look at, there were intense discussions about this and they were memos that adequately document into it but we simply could not allow a plant that was unsafe to ship florida -- formula? dr. mayne: we anticipated that this would happen significant impact. that is why we made the decisions we did. not to have those products recalled because the concern of these infants were greater. we heard from other manufacturers that they had capacities to increase production and they have. they have increased production and that was the scenario planning. we also invoked all kinds of mitigation steps we could. medication to reproduce regulatory -- at those flexibilities like asking the retailer to limit purchases. we did numbers of steps. we are in a tough place where we did not want to allow this unsafe formula for. under unsanitary conditions. rep. rodgers: feel like i am -- on one hand, we are told that the avid plant --abbott up and running in a couple of weeks. i know you testified that concerning the whistleblower complaint that the integrity of the organization was compromised. one hand, -- on one hand, how do you believe that organizational integrity can be restored in just two weeks if they are these concerns. dr. califf: i have 30 seconds? -- may i have 30 sections -- seconds? given what we saw, the only way we could have confidence is through -- with the ceo, there were hundreds of steps that they went through they do. many of which have been done. it is only that we have direct oversight that i have confidence. i have confidence we are having every step. physically in person and following the documentation and the experts. rep. rodgers: -- >> this year will go to miss rice. -- the chair will go to miss rice. >> thank you. i think we have to dig deeper on how we can avoid the current disaster in the future and we have to understand the miss opportunities that led to the recall and apply the lessons going forward. you would after the pandemic and -- ink after the pandemic and what we didn't have enough would have enabled us to look at these critical that every day americans need just to survive and make sure this would not happen. it is clear to me that the delay between the fda and the expansion of the plan in 2021 and the fda inspectors return in 2022, which was also after illnesses, was a missed opportunity. commissioner, understanding you are not at deposition you were now at the time. what steps have you taken to ensure that we will not see something like this in the future where it will take four months after notification of illnesses before the fda initiates an investigation into -- dr. califf: most important one is the escalation requirement that is notifying the leaders and it is documented in our report that mr. yunus, dr. mayne others were not notified until february that all of this was going on and -- we have to have standards. i worked in hospital quality. -- nurses were empowered to report it. not is a punitive matter but to make to -- as a punitive matter to brush -- to make the system better. we have vulnerabilities. we have a workforce and a mist of a pandemic which is still ongoing and an underreported -- underfunded segment. whenever i worked in corporations, -- it is very different when you have good people who could do other things for a living who are really straining to do things that computers can do automatically. rep. rice: dr. mayne, according to fda testimony, after becoming aware of the illness in 2021, the agency notified avid -- abbott. our understanding that inspectors on-site conduct the the negation of the plant were not told about the complaints at the time of the inspection. why were the fda inspectors not informed of the complaint and you believe were timely communication could have facilitate -- dr. mayne: once the agency receives a complaint like this, we have to follow up on that and everyone of these complaints were followed up on. reaching out to who fought -- made the complaint and getting medical information with regard to the complaint and that process does take time. the product was obtained and went under testing. the final testing results weren't available -- until october 6. have we know there would -- had we known their was an complaint, we would have known the details involved. we would have loved to have that information the moment the complaint was made but that is not what happened. in every one of these complaints, the fda did follow-up with exact procedures to get as much information. that is critical to inform what you might look for in a plant. rep. rice: that there is three companies manufacturing such an essential product, you should look at increasing domestic production on that front. i want to think the -- think the witnesses. rep. degette: mr. burgess, you are recognized -- i will go to mr. mckinley. >> thank you. thank you for this testimony because the plant is just one example when government agencies and the private sector companies do not get out in front and disclosed safety issues that impact public health. there was a twitter account, a tv producer click on social media that there were multiple inspections showed no issues of the plant and the fda feel that we passed last week was unnecessary. this statement was set -- sent out last week across the country. augmentation of these violations were reported during the last several fda inspections. the plant established there were problems at the plant that led to a recall and a plant closing. things have escalated to a public health crisis. the fda and the abbott pleas for silence. this statement was sent last week saying the government was wrong and there were no problems. wonder, there are consequences when this type of an -- miss information is not rebutted. the public continues to lose confidence in the governmental process. we in congress did not hear about the scope of this issue until early may and the administration seems -- to be caught off guard. why did you not -- i want to hear it again. why did you not inform the public in january or earlier about the problems of the plants? dr. califf: did call miss maine -- we did call miss maine. there was a public announcement about the problem of the product and the general reason needed to be recall. in the midst of a dissent -- consent degree negotiation, it is difficult to talk about the specifics. rep. mckinley: do you to combat the type of social media providing incorrect public health information? how do you respond to that? dr. califf: i am smiling now because i think it is funny but because it is critical that we get the information -- misinformation situation under control and i worked at google for five years so i saw the good and bad of access to information. the eight will have to change its strategy to be more proactive. the strategy with russia and ukraine is one of the best examples in history of being one day ahead of the misinformation. rep. mckinley: to reclaim -- i have to reclaim my time. how will the passage of the fda bill up reformer? -- increase the production of baby formula? it was not just one, it was several. i want to know how do we get back to production and put $28 million -- how will that increase production? dr. califf: that rapid plan --ab bott needs to get back over there. as we bring in supplies from other companies, -- countries, we have overseas plants that we import from. we have to inspect and make sure it is the quality we expect of american formula and we need to update information systems so we can keep track of it and make sure we are coordinated. rep. mckinley: the fda had a medication and plan -- in place before the plant was shut down? dr. califf: asked dr. mayne recounted, we had a number of steps to keep production off and it did increase on a national basis of the person sitting -- the purchasing outstripped production. rep. mckinley: thank and i your back. -- i yield back. >> i was going to begin by saying i am concerned. a lot of us have talked about it but it is more of that. i am areas about the fda's lack of food safety leadership, communication, and access. i to ask unanimous consent to begin by putting into the record a and death -- in death --depth report -- fda food failures. it is based on 50 interviews and it goes into detail on what was done in 2022. >> we will do all those unanimous consent request at the end of the hearing. http://twitter.com/cspanwj -- rep. schakowsky: is an ongoing joke -- that i've heard that says that -- it is said by fda employees that says that the path in fda is silent. --f in fda is silent. we have not seen this as a priority in the fda and now we are. i cannot tolerate any excuses. i have one question about timing, although i think my colleagues have done a great job in talking about the various delays that were -- according to fda testimony, staff received the whistleblower report in october of 2021 and senior food staff officials did not respond to that report until four months later in february. how does that happen? how can that possibly happen and when to ask you that of the administrator? can you hear me? hello? dr. califf: i got muted. in point out that complaint was received and it was locked in right away. the or a employees did their usual review. it went to the criminal investigations unit because there was a concern that the informant needed to be questioned and brought in to go over things. issues that delayed it. i can't go into details because they are personnel related to that -- we are on record that it took too long and on top of all that, -- lack of escalation causes -- senior officials were not aware until february 10. rep. schakowsky: so much has been said today that needs to change the focus. i know you are new to this position but you have a long history with the fda on these food side. we are calling for you to change the focus, the emphasis to really put food tired of seeing one after another of these times of situations. i wanted to alert you i have introduced legislation that deals with chemicals that are in our foods that are toxic. they are non-toxic chemicals. i have legislation that would require research and removal of them from our food. i hope that you will consider that but we don't want to hear anymore about this without swift response team food and drug administration. let's put food back into the food and drug administration. i yield back. >> chairs audio is out so we will go to dr. burgess. are you on? mr. long, five minutes. i would -- >> how would you rate your personal performance? dr. califf: i would give it a four or a five. >> how would you rate the urgency within your administration from one-10? dr. califf: with employee's, it is 9.5 out of 10. i would stand behind their effort. the result is not what it wanted so i cannot give it a high rating. rep. long: how do you account for that? dr. califf: the people working on the ground are working there tails off working as hard as they can with an adequate systems and funding and we did not meet the the rating for the hard-working employees is -- rep. long: is it systematic or money? i am confused. dr. califf: it is a combination of leadership, people, money, and technology. i am aware of the technology gap coming from the technology gap now with technology which is outmoded. i think it is a combination of all of the above. i knew before coming in, the food side -- luke needs to be brought in the fda. it is a major issue that will be everything looked at what the day i was confirmed was the day the recall made the news and we have been engrossed and that, trying to take care of this problem for the first three months of my time. rep. long: no anyone in the hearing that is not curious that is -- the fda will --role -- set the fda has been briefing them about the fda situation for months. is that accurate? dr. califf: we communicated with hss and communications with the secretary throughout the pandemic about the baby formula. rep. long: was it the fda's understanding that the secretary -- would reach the white house on the shortage? do you have any idea when that briefing occurred? dr. califf: do not know the answer to that question. at communications with the white house. they are part of the supply chain effort which has guided us through the pandemic. rep. long: should to that question on whether there was a brief and when it occurred? >> [inaudible] rep. long: hhs secretary price sarah, has he provided guidance or import and what guidance has he provided? dr. califf: he has been helpful supplying formula enforcement distraction, enabling foreign suppliers to send in and got on the phone and called ceos to encourage them to increase their production. among many other efforts to support, even in the last week when people know he was six -- sequestered in germany with covid. he was on the phone putting in good work. rep. long: no anyone in nate this hearing that is not curious on what we have been going through and what parents have been going through, freaking out. i saw someone on -- someone in the administration set the investigation was go to your pretty attention see if they have samples and being a father of a coke pediatrician, i can assure you that she does not have cases of baby formula sitting around in her office. rep. degette: him -- i am having audio problems with my computer. i would like to recognize -- or five minutes. --for five minutes. >> as we have learned over the past two years of public health guidance, clear communication is vital. it is fear following the recalls that led families to earn two unrest -- risky solutions defeat children which makes me wonder why there was so little communication to the public on the fda. fda did not want the public about the potential risk of consuming -- until february 17 following the announcement that the company was voluntarily recalling these products, there have been discussions about the delay but with the benefit of hindsight and doing the impact of product recalls would have on formula supply, do you think the fda should have provided more public guidance -- and supply opportunities in the u.s.? >> safety issues and the supply chain issues. when it came to the safety issues, and i became aware and started working with the coordinated team, we work quickly to pull product off the shelves. when we had information the product was unsafe, the -- it was communicated to the consumer. we wanted them to avoid consuming the products. at that time, i don't think there was anything actionable to communicate to the american public. i am a strong believer of transparency. maybe you should have talked more about the current state of supply chains but i think some warning that there might be supply chain george's coming but have led to some type of panic. we did the right thing on the public health portion and safety. he told the american public that we should have avoided these products and try to share as much as we could. >> you help shed some light on how the fda food leadership is coordinated with respect to the investigation. how does the report of infant and a host distributed by the fda, was the information shared amongst all key food personnel in a timely manner? -- >> those are two different things but if you go back to the beginning, it is noted in our timeline, there was a barrier to escalate which was a system failure so neither mr. yunus or dr. mayne nor ms. mcmeekin ahead -- head of the office of regulatory affairs knew of it. until early february. >> all infant formula in medical food staffs -- in october of 21, -- regulatory affairs review and discuss it with the fda office of criminal investigations. yes or no. is this a lack of coordination or at worst, a breakdown among leadership? dr. califf: it was a lack of coordination. >> understanding this transferred before your new tenure formed your leadership, how do you present -- plan to address the food safety leadership breakdowns within the agency? dr. califf: as one of your colleagues noted, is broad and includes things like chemicals in the food and the outright -- outbreaks we are talking about here. where we will need to make changes across the board, it is not just structural, it is the people and the resources and -- [inaudible] ghost dance to be addressed. -- all those need to be addressed. weedy congress to approve changes. -- we need congress to approve changes. rep. degette: the chair recognizes mr. popper -- >> my colleagues for the thoroughness of their questions. i want to bring up an article in the washington post that has some revelations. i want to talk to mr. yunus. you are that deputy commissioner. -- the leader of the fda -- is that true? yiannas: it is true. >> food safety problems were reported to the -- a medical doctor who was acting commissioner when the whistleblower complaint arrived. when did you get access to that report? yiannas: i believe i got access to it around february 10. >> did the -- the report has been out for months. is that correct? yiannas: yes. >> why didn't you get to report? how is it that it got tied up to the bureaucracy and it didn't get to the person to respond to it? yiannas: not sure why the report was not shared with me and how it did not get escalated. try to get to the bottom of it. -- i will try to get to the bottom of it. yiannas: i know commissioner -- rep. tonko: know commissioner -- >> commissioner califf, is this typical of how whistleblower over ports are handled -- reports are handled? dr. califf: i have been in -- in evolved -- involved but we did a extensive review of it. >> that is not my question. the question is you have deputy commissioner of food policy and response who was shut out of the process and the old saying in management is the personnel is policy but it is also management structure. mr. yunus, i understand that you were working on the food program to ensure that failures that led to the crisis would not occur again. have you been abated or impeded in that effort? yiannas: we have had a collaborative effort. we knew that responding to staff and being right was critical. rep. palmer: what i am asking you is -- i am trying to find out is according to the washington post, you are told to stand down and the effort to reorganize it was in order so you could do your job and help the fda organize a matter that -- since my opinion. the fda focus more on medical issues than food issues and that is why -- another representative brought out -- up. yiannas: it was very unethical -- i was called by my fda personal mobile, the person identified themselves with someone i work with regularly. that article -- the investigation will be led by the commissioner janet woodcock. rep. palmer: i believe that would be a come -- contestants that we want the fda structured that when the issues arise, we know that for two years the fda did not do inspections. the issue didn't meshing them -- mention them. that is not accept best -- acceptable. i hope the committee pursues this that the -- we have the right structure in the fda to make sure that one happen. rep. degette: the chair while recognized mr. peters. -- will recognize mr. peters. minutes -- or four minutes. please unmute. he has no -- ms. schreier, are you ready? >> can be ready. rep. degette: you are recognized for five minutes. >> thank you, madam chair. this is a distressing time for parents with infants and parents to be. most babies, even if they are breast-fed will at some ploy -- point light on formula. for kids under four months and even under six months, this is their only source of nutrition. there are some babies with allergies and conditions that require them to take a very specific type of formula that they cannot live without. i am glad to have this conversation today. we figure out what happened it is important to look ahead. what can we done to make sure this never happens again. when i was practicing as a pediatrician, we would get notifications that we were running short on certain medications. there was a list of shortages. you mentioned the shortage of -- pro football -- this is important for doctors to know because it lets us make important decisions on what to use during an operation. or whether there are alternatives. there is nothing else and it keeps them alive. is that kind of warning system will make sense? is there any early warning systems for products like baby formula, not the same ingredients but for, itself that the manufacture let you know if they have a shortage? dr. califf: let me thank you for being a pediatrician. i called the academy of pediatrics for the positive vibes that you exhibit as a profession. there is not such a warning system. we asked for that authority and have not been granted. the industry has opposed. rep. schrier: is that authority come from congress? dr. califf: you require congressional authorization. -- no what did you cool -- i know what digital technology can do. there is no reason we cannot do a digital system to enable us to do stress testing. rep. schrier: i understand that there has been weird behavior. people get nervous about omicron and they buy baby formula and that exacerbated it. there are underlying issues. there is another thing i want to touch on. we are talking about these efforts to reopen the sturgis plan. --. you made damning comments in the 2021 inspection and -- that makes me worried and you said you put in hundreds of requirements they need to fulfill before that could be opened but when i read about bobbing empty cans, not really reporting on different weights in cans, it feels like there is corruption from the top down and ate the plant. are you insisting on the full change of staff and employees and how are you going to oversee this so that you feel confident when this opens, we are getting safe formula? dr. califf: you alluded to it but you know our position to either confirm or refute that there may be proceedings. regard to specifics, every step of the way, we will be there until we are comfortable not just at the plant is ok but that the systems are the right people to be in place. we can't inspect every batch of every element of every plant. we have to spend our quality systems. rep. schrier: you have to trust the information you are getting. some of this was found coincidentally. we did not. bout it back in september when all these problems were found. i am wondering about the other formula companies. how sterile are their conditions? how do we trust them and what do you say to parents who are worried? rep. schrier: -- dr. califf: the standard is once a year. we fall -- fell during the pandemic but we are up and going in the plants will be inspected once a year with diligent inspections. rep. schrier: to, they have been safe. -- dr. califf: formula on -- the formula is safe. >> mr. joyce, you are recognized. >> after visiting a local supermarket, i reached to a supermarket -- market change to hear the concerns about baby formula. can you elaborate and describe the plans for distribution of baby formula that is being imported from foreign companies and how the formula will reach rule parts of the country in -- and in pennsylvania? >> i appreciate [inaudible] a. i published research patients about the decline in life expectancy -- air to urban areas. we are aware of that. we are going to wherever infants are who are dependent on this special formula who have critical medical problems no matter way -- where they may be and pediatricians -- and each of the producers has a number you can call. if you have an infant who requires a special formula. rep. joyce: my time is limited. your recommendation is the pediatricians in the family doctors reach out to hhs and let them know about the concerns that they are worried about? dr. califf: i am talking about the special infants with medical particle -- metabolic will -- we are talking about the -- network of communication about this. we recognize there is a great shortage of rule --rural positions. call hhs. we will be responsive. rep. joyce: we will reach out to you. this is for director maine. we understand the fda recognize coronavirus at the plants. -- rep. rice: there were 4 --dr. mayne: two of them had isolate of the passages -- pathogens. for two of those children, we had no dedicate -- genetic material compared. -- available. they were not the same. rep. joyce: when did the fda collect the samples that they used to -- dr. mayne: those were conducted as part of the expansion. this was a before cause inspection. we collect a lot of information and send the samples to the labs and wait for those results and while we are waiting, we started to prepare when the results would become positive, what would we do? rep. joyce: the testing did not show the strengths to be identical? dr. mayne: we can't rule in or out whether or not the benefits, their crew and a factor was caused by the plant? the data cannot be used to inform it. rep. joyce: by that genetic testing you did, it does not match from the plant? dr. mayne: correct but we did not have any sampling done at the same time -- we did not have that. rep. joyce: commissioner caliph, there has been some suggestion that the fda should have called the white house chief of staff when the plant closed. the implication is the fda did not reach out to the white house. when did the fda alert the white house about the closure of the plant and who was alerted? dr. califf: in early february, there was communication about the chain. no -- i know we did not talk to the chain of staff but there was communication with white house staff as a regular event and there are memos that list and i think there is an elegant description of the issues. rep. joyce: what agencies are involved -- what was reference in a recent interview? dr. califf: are multiple agencies, the cdc is involved in the agricultural department. the wic program is a large part of the infant pharma -- formula enterprise. there are many agencies involved because there are many complicated aspects involved. rep. joyce: my time has expired. i yield. rep. degette: for chair recognizes mr. luis. >> from a public health perspective, this is appalling -- [inaudible] rings of twins and do we rely on formula in addition to rest will -- breastmilk. -- the anger they feel for the insane prices they are paying online. this would be terrifying for any parent board even more so without -- for those who don't have the means. axis iv bailey -- baby formula -- prices for baby formula -- x -- they are price gouging percentage more -- are facing a huge disparity in our country in terms of who has access to basis necessity and who does not. i am grateful for the expertise of my witnesses today and i want to ask what the people can do to secure safe formula for children and thinking about the families who have been this purported -- this important dish -- disproportionately affected. the fda has announced multiple actions to increase availability of formula. i am pleased by the news that abbott has agreed to the consent degree. american families need formula for the children today. what can families who are searching for formula and those disproportionately affected by the sorters, what can they do to get the product they need to feed their children? dr. califf: problem you describe -- the probably cute described is branching and refers me back to my days as a parent. we have an answer. [inaudible] it should read it as fast as we can. -- distributed as fast as we can. you on the hhs website a good description of community resources which are critical for the populations you just described. great thing about america is communities are coming together and making supplies available. all of those measures will be needed before we get back alone. rep. ruiz: i have heard reports that some americans have turned to riskier options as online -- homemade formula and online scams. what do parents need to know about these harmful options and what recommendations do you have for them and how is the fda -- [inaudible] rep. degette: in terms of these counterfeit harmless, what we advise consumers is to avoid single purchases coming from abroad that have not been through an fda a few -- approved facility. we urge consumers to be conscious about that. we urge them not to make formula at home because we have seen problems there and not to dilute harmless because that means those babies may not be getting that tradition -- nutrition they need. we are surveying to make sure these counterfeit harmless do not come into the country. that is some of the resources that are in -- for the implant formula -- infant pharma. rep. ruiz: i appreciate the administration is working to address these issues. thanks to operation side formula, we have cut transportation time from europe from weeks to just a few days but we must continue this approach to make sure no child goes hungry regardless of where they live or how much their parents make. i yield my time. rep. degette: gentlemen. the chair recognizes ms. custer for four minutes. -- five minutes. >> thank you for holding this hearing. i have had some complications today but i was picking up my husband from the hospital so i did not mean to give anyone a fright when i was driving in the car. i am settled at home and delighted to be with you. families across the country are scrambling well formula, driving miles across state lines for local donation. falling victim to scams out of desperation. while the plant's responsibility and i am shocked by the conditions, it was ultimately the safe thing to do to ensure the health of infants. it will take industry wide dedication to increase production so that retailers can keep their shelf stock. your testimony states that gerber -- i am on the wrong panel. i am sorry. i will have to pass and come back. i apologize for the complications. so sorry. rep. degette: mr. peters, is your sound fix now? >> i am -- rep. degette: you are recognized for four minutes. -- five minutes. >> there is a bipartisan concern about this policy. i cannot get it out of my mind the context of this hearing is what happened in texas and i would love to see the same interest in preventing our children from being massacred in their elementary schools as well as the politics on that as well. commissioner, the fda has announced numerous actions to address the ongoing shortage. making it easier for to import safe and new -- nutritious products. increase supply. key tell me how the fda is coordinating with other agencies to alleviate the shortage? rep. degette: commissioner, you need to unmute. dr. califf: i thought i was doing well. in response to your question, we coordinate with all the relevant hhs and government agencies, including the cdc and economic advisors and the supply chain committees that have been in place throughout the pandemic. i want to say i have been amazed -- they have not been sleeping and working on weekends and nights to pitch in on the government response. the industry is responding quite well with pretty substantial -- in production -- [inaudible] they have risen to the occasion and the global industry which for reasons, have largely not been involved in importation into the united states. i feel people are pitching in. the effort is being made. rep. peters: shortage has been exacerbated by the voluntary recall of products because of the corona factor. the three major companies are 95% of the market. at the burden of this shortage has fallen on all income families. we have 4000 families who receive wake benefits --wic it's. -- it's. you testified you and dusted money into production and enhancing safety and quality. how much are the resources -- >> be on the wrong question? -- you may be on the wrong question. rep. peters: i'm sorry. i had the same problem -- >> it was a good question. rep. peters: how are you coordinating -- what is the way you are reaching out to manufacturers and consumers to alleviate the parma shortage -- formula shortage? dr. califf: i spoke with all the ceos around the world but our team at the working level. ceos have conversations. they are working and they get it done so we are in constant communication going back and forth. each of these efforts like importation requires multiple different people to work together in ways for. rep. peters: thank you. madam chair, i yield back. rep. degette: you are recognized for five minutes. >> thank you my -- think you very much, madam chair. i was pleased by the timeliness of the consent decree filed just nine days ago. this agreement sets in motion the critical process of habit retaining assistance to bring the sturgis facility into compliance and you can safely restart production of interurban -- of infant formula. billy oversight of abbott's actions will be critical to ensure the consent degree is maintained. commissioner califf, what can you share with us about abbott's implementation of the consent decree since its filing? dr. califf: as i mentioned yesterday, we met with abbott's leadership yesterday and reviewed hundreds of steps they have taken, many of which are done. as i would expect from the industry i know well, there are very detailed charts and graphs that a recording every step of the way what is happening and how close to complete they are, and i do believe they are making substantial progress, and i feel optimistic about it. in fact, they were originally quoted as saying two months to get product out on the shelves. that has now been cut to one month due to the decisions that have been made about the type fraud act -- type of product that will be put on the line. the special product for those who have allergies to milk will be first on the line. so i think it is going well. >> what change do you think i have it needs to make to improve sanitation of the facility for the fda to be confident it can safely begin production of infant formula that american consumers can rely on to safely feed their babies? dr. califf: thank you for that question. i was about to say, i have a really good history with abbott in my past as a doctor, but this was beyond the pale. so we are watching every step, just as an example before they will open production they will completely cleanse the whole production area and take samples, look at those samples, then do that twice more. that will happen three times before the open to production area. they have completely redone the roof, redone the floors so there is not drainage on the floor, and they have expanded the area in which people must exert sterile precautions, which was too small in our inspection, and has been expanded out. there are dozens of others that i could name. >> what if any contingency plans does the fda have in place to ensure the adequate availability of infant formula in the months to come, should it take abbott longer than the estimated several weeks to get the sturgis plan operational again? dr. califf: that is a great question. and what i would say is that we are not going to stop with our importation plans and increasing our production by the other manufacturers until we are comfortable that we are back to normal levels. i would predict a surplus a few months from now, because we want to have access for all of the reasons your -- your committee has said. there is substantial global capability in infant formula. the largest manufacturer, nestle, as a small presence in the u.s., but they are number one in the world. i'm optimistic that over time we will have plenty of formula. but that does not -- i don't want to make light of the fact it is going to be days to weeks until we get there. >> our constituents are struggling right now, and as parents many of us on this committee, mothers and fathers that have dealt with feeding young babies and also my heart goes out to the people with work schedules that they have to worry about, that they are spending so much time in this, trying to get safe formula for their babies, and the cost. i have one last line of questioning, if i could. i know in this part of the country -- i'm in new hampshire -- we have milk banks of mothers' breast milk. i'm wondering, what is the regulation by the fda, and can we ensure our -- assure our constituents that breast milk from a milk bank is safe and is thoroughly vetted by the fda? dr. califf: you are asking some very good questions. i'm going to refer this to dr. mayne, who probably would have the best answer. rep. kuster: human breast milk is regulated as a food, so that is reassuring, and they have to have proper screening protocols and things in place to make sure the donors that are donating the milk, that is critical for human food safety. that is how i would respond. rep. kuster: my time is up, but i will submit further questions for the record. to keep your indulgence, i appreciate it. rep. degette: i think the gentlelady. i know you have been dealing with a lot, so our wishes go out to your husband today. >> as many of us have known, and many became recently aware, infant formula is more regulated than most food products in the united states, reflecting the full ability of its consumers. robust regulation only ensures product safety, but also helps consumers trust that the product they feed to their children is of a high quality and will meet their babies' nutritional needs. dr. mayne, in light of the search for a solution, some makers have called for deregulating infant formula production. can you share about -- a bit about the regulatory standards and effectors of infant formula must a hereto and why they are so vital to ensuring the high quality and safety of infant formula in the u.s.? dr. mayne: thank you, congresswoman. the statutes are that we need to make sure these products have appropriate nutrition as the full source of nutrition. that means they have to have the right amount of 30 different constituent vitamins, minerals, things like that. they cannot be too high, and they cannot be too low. that is the nutritional side of this. they also need to demonstrate appropriate growth. there is growth monitoring data required as a critical source of nutrition. at the same time there are safety data. when we review formulas we also work with the office of food safety to ensure the production is done in a way the product is safe. that is what the regulations require. what we did announce recently is regulatory flexibility while ensuring safety and while ensuring nutritional adequacy. and that is important. for example where we are looking for flexibility, certain labeling requirements that are not critical for safety, we would provide regulatory flexibility. the label is critical for things like allergens. we don't want babies to have a reaction because allergens are not properly labeled. also, the preparation instructions are critically important. if consumers don't know how to prepare the product and you could get the wrong ratios and do not get the nutrition you need. the regulations are there to protect all of those infants. i am a mother. i am reassured we have those regulations in place. at the same time we recognize the challenge we are in and we are applying regulatory flexibilities while protecting nutritional safety. >> i appreciate that. as manufacturers expedite production of infant formula and the abbott facility completes corrective actions and restarts operation, what is the fda ensuring -- doing to ensure the available or millis remained nutritious for infants? dr. mayne: everything coming into the market through our flexibilities is appropriate for nutrition and safe. so that is clear, and i will comment, as operations fly forward, one of the things we noticed we have new products coming in. it hasn't been in the market before. this is coming from u.k.. this is the product we announced very recently. that is 2 million cans of general infant formula -- not the special formulas, but general formula. he looked at the data as part of our flexibility to ensure that product meets our nutrition and food safety standards. that includes information on microbiological testing the companies have done, along with production. we are making sure these are comparable to the u.s. market with regard to nutrition and safety. rep. trahan: thank you. commissioner califf, conducting oversight is not without significant cost, and as has been discussed today fda's food safety activities have been chronically under resourced. we understand you are conducting an internal investigation also regarding fda's response. you please describe the scope of that investigation and whether it will include recommendations on how to improve fda's future responses and whether the findings will be made public? dr. califf: well, let's divided into two segments. on the other hand we have the sit -- the specific response, the action that dr. solomon is leading. the interviews are well underway of the people involved. i want to stress, to my knowledge there is no malfeasance here. these were people working very hard, but we have systems that were failing and decisions that could have been better. those findings will be made public. no question about it. but there will also be a review of the entire food program, which is vast and includes things he will have discussed, including chemicals and nutrition. what some of the discussion has been about over the last three months. that is going to take longer because we need congressional approval to make changes to a program like this. rep. trahan: we are eager to get those resolved and eager to get the formula back on store shelves. thank you, madam chair. i yelled back. rep. degette: thank you so much. mr. burgess, you are recognized for five minutes. rep. burgess: i'm trying to unmute. it will not let me. rep. degette: you are unmute it. >> you were. you are muted again. rep. burgess: ok. how is that? dr. caliph, very good to see you again. -- dr. califf, very good to see you again. it is a terrible problem, and of course you have come on board just a couple of months ago, and this problem has landed at your feet. i appreciate the efforts you are making. it strikes me, though, that this is a time to have somebody who has spent time at the fda in the past and time in the digital world in the interim and is now back at the fda, several members have mentioned our food safety efforts even going back to 2006. during that time i remember it kept coming up that the modernization of information systems at the fda was a critical missing piece of this. it strikes me that this is an excellent time to have you there, because you are the one that can be the architect of that fda modernization, that fda digital transformation that clearly has been lacking and so critically necessary. >> are you still there? rep. burgess: yeah. dr. califf: you mold me -- you want me to respond to that? rep. burgess: i wish you would. dr. califf: as i mentioned, i was enjoying a nice life under the sector -- in the private sector, and this is one of the things i thought was so critical. i did not expect to be asked to come back, so i did jump at the opportunity. i know mr. yiannis and dr. mayne have an interest in the technology. i would say i am not the architect, but i am may be the boss of the architects, because this is a -- rep. burgess: well, you referenced that you are going to need authorization help from congress, so you have come to the right place. this is the authorizing committee where we need to work together. certainly i look forward to hearing from you beyond this hearing as to just what the tools are that you need to be able to implement that digital transformation. because, gosh, it has been painful listening to the timeline. october 19 for the whistleblower letter. the fda caught on that there was a problem in september, but then the whole thing kind of fell apart because there was not a new segment until february, and we are where we are now with the lack of supplies. but i am encouraged by what you said about your efforts to remedy the problems at the sturgis plant. i just wish they could have begun in october. >> go ahead. rep. burgess: just to add one more thing, i hope i can get congress to imagine the life of an fda investigator living in a digital world which is modernized. how much more efficient and effective and happy those employees will be. i am 100% confident that if we get the right technology -- you say it is not just one thing, the technology and people interfacing is what is critical here? dr. califf: obviously that was the missing link between september, october, february, and where we are today. i guess the good news in all of that is you have a structured program of remedies that you are implementing at the sturgis plant. just give us an inkling as to the timeframe over which those types of tasks can be accomplished and sturgis can be up and running and producing for the american people again. dr. califf: yes sir. the sturgis plant, we met with the ceo and his team yesterday. we would expect by june 4 production will be underway, and within a month from now, according to abbott's own projections, we should be having formula rolling off the production line. i've already mentioned that there are hundreds of steps along the way, so if any one of those goes wrong, you know, that will cause a further delay. but we are talking every single day, and i believe they are making best efforts at this point to make this work with all hands on deck. rep. burgess: let me ask you a question that i think was brought up dr. joyce on the similarity between the genetic makeup of the bug that caused the illnesses and deaths and what you recovered from the plant. do we need to be concerned that there are some missing pieces here, and perhaps there is part of this story that has yet to be shown to us? dr. califf: there definitely are missing pieces. i'm confident they will be filled in, for the reasons dr. mayne already sent. we don't have samples that are simultaneous in the infants and their surrounding environments and the plant. i will also just point out, you are a doctor, whole genome sequencing has taken images much like facial recognition on your computer, and there are errors in sequencing, or variations that occur where you get a conclusion that something like we are not sure it matches, but we are not sure it doesn't match. so all those things can happen, which will leave us being inconclusive about those links. but we will continue to learn more. one final thing to get in -- corona back to is not a reportable bacteria. compare that to what happened with peanut butter. within days we had genotypes that linked things and were able to act. we need to make coronabacter a part of the database. rep. burgess: thank you. rep. degette: mr. o'halloran, you are recognized for five minutes. rep. o'halleran: thank you, madam chair, ranking member. an incredibly frustrated that we are here today at all. as a father of three and a grandfather of four, the thought that any of -- anybody, children or grandchildren at any time in their lives, were going hungry during this critical development phase of their lives is unbearable. while clearly there are issues that must be addressed, regarding the plant, i want to hone in on the fda's failures between -- actually october and may. when the shortage of baby formula became a full-blown crisis. it actually goes back to -- oh, let's go back to the 1990's. because we have to be able to address things in an orderly fashion throughout time. and there were problems with this plant back in -- back then. they have not been sufficiently brought to bear time and time again. part of my previous life i was in long-range planning, and redundancy issues. so understanding that this is not the first time this has occurred, isn't that the first time there has been conditioned that the plant that were problematic? and that this is a sole provider of some of the food for our children in this country? the abbott plant has -- or, what i heard today, has no backup plan? i come from a business that if you are down for a second, you are down. and, you know, so that is what you put in redundancy across the board. to make sure on something this critical is addressed. and so our citizens do not have to have this problem. and the new york times said in an article just this weekend, long history of problems in this plant. so i don't know what the protocols are. but whatever they are, they need to be reviewed. going back in time, taking a look at other facilities, identifying clearly how not to have this happen again. and being aggressive about it. and it is sad when i hear dr. burgess say that the information systems in 2005 are still not up to the level they should be. we as a congress have to look at that too, but also administration after administration have been lacking in addressing this important issue. whether it is the roof leaking -- we don't allow these at our plants that address food to our people, our citizens of this country, and especially for those most vulnerable. and when we go and look at what has heard there, i don't understand -- i fully understand, you know, that we have had an agreement, but people can work on parallel tracks. and why this wasn't -- i haven't seen where this is been worked on in a parallel track across the process. so that we anticipate that this consent agreement was going to have her and we were looking long -- working long before the consent agreement to address these issues. the ranking member, clearly identify the timeline here. and in the world i come from if you have a timeline like that you have a big problem. and that should never happen. and once that timeline was -- that clock should have started taking then, and never stop until it was addressed. but i'm going to give you some time to talk about those issues, but i just had to make those comments. thank you, commissioner. dr. califf: well, i could not agree with you more about your general sentiment. he would think that a critical industry like this would have resilience plans, redundancy, but we don't even have legal authority right now to require that the firms have a plan for potential failures and resilience. that is something we have asked congress for every year for a while and we are asking for it again. so i hope that it happens this time. i would also add that this is not unique to this industry. we are seeing this across the entire device and medical supply industry, with frequent failures, as exemplified by the 60 minutes show and the contrast media problem. you have got to a just-in-time, large single source contracts that lead to a lack of diversification in the industry. in the industry has fought us to -- to the nail on requiring there be insight into their supply chains so that the sum of all of the industries leads to the avoidance, the preemption. we would like to be able to a stress -- to and prevent these things rather than waiting until they happen and scrambling. i know the chair wants to move on. -- rep. o'halleran: i know that she wants to move on. we should also talk about whole planning and working on a continual basis to get things right. rep. degette: i think a gentleman. we still have a second panel, so we are going to move on and we now have a number of members of the committee who have waved onto our subcommittee. we welcome you, as always. we will recognize you for five minutes. stem going to recognize representative dingell for five minutes. >> thank you, madam chair and ranking member griffith. i share the outrage of all of my colleagues and i guess there are times of want to say that everybody involved here, as we get into these trite conversations about whether this formula or this plant was contaminated, infant formula was being made and delivered in a contaminated plane. but we will talk about that in the next one. the fda's charged with the authority to ensure the nation's food supply. coordination with other agencies, particularly the cdc, is crucial in times of foodborne illness outbreaks. this recent crisis has demonstrated just how vital this interagency coordination is not just for public health, but for the broader societal implications for a product millions of american families rely on for the safety and nutrition of their children. dr. mayne, following initial reports of illnesses linked to the consumption of infant formula, how did the center for food safety and applied nutrition coordinate its investigation with cdc and state department of health? dr. mayne: thank you, congresswoman. in any foodborne outbreak investigation or consumer complaint investigation we coordinate closely with the state, as well as with the centers for disease control and prevention. in this setting some of the genetic sequence data and some of the product samples, that was done with the states. but we work in partnership with states to get the information we need to inform these investigations. so, close coordination throughout. as you heard our commissioner say, there is an issue that corona back to her is not -- coronabacter is not a -- the pathogen that made them sick. we did not have those tools here. what we had were two case complaints that came in. we had no idea if they were linked by a point source. we had no genetic information available. new they had consumed powdered formula from sturgis. we also know sturgis is part -- is a big part of the infant formula market. had that concern, but we need science. with the idea we could potentially one parents, had we warned parents without strong scientific justification for that he have potentially contributed to the shortages we are seeing today without evidence, in fact, that there was a contamination problem. we had the inspection, we found the bacteria. we found multiple strands of bacteria in infant formula manufacturers around the country. our experts at this plant had seriously concerning conditions. unlike things they had seen in other plants in the u.s.. rep. dingell: let me build on that a little, and i'm going to give you a two-part question here. clearly all of us are going to command of this hearing saying we need to look at what we need to do to be able to get at coronabacter faster. whether process is followed for the infant formula investigation, within the same as for other foodborne illness investigations or whether factors unique to the coronabacter bacteria or infant formula? and, dr. mayne, with the benefit of hindsight, in what ways could center or fda coordination with the cdc and state or federal agencies be improved? mr. yiannas: i would say the process we follow it here were the same as what we would use in an outbreak investigation. we used our coordinate an response team. that is a dedicated team of individuals, and that is their job, to investigate foodborne outbreak investigations and these critical illnesses. one of the things different in this infant formula situation is, you don't have the challenges with trace back or traceability you have and we are doing investigations. rather the parents could tell us what specific products were fed to these infants. so we use the same processes, but the data and information we had available were different in this investigation. in terms of improving coordination, we work hand-in-hand with cdc on all foodborne outbreak investigations, including this tequila situation, daily contact with cdc on these types of investigations. rep. dingell: would there be changes you would recommend so we might have prevented some of what happened? mr. yiannas: in terms of prevention -- dr. mayne: in terms of prevention there are authorities we think could be helpful to prevent these types of things from happening. for example, we could consider new authorities around what industry would need to do with regard to their own testing. we have learned the importance of testing, the environment that the food production facility, so there are things industry could do if they found a bacteria. it could be provided to provide sequences to the fda to build a database of information to solve any future situations. rep. dingell: thank you, madam chair. i yelled back. rep. degette: mr. upton, you are recognized for five minutes. welcome. >> thank you for allowing me to avon. i know we have a good number of questions. there is not a bigger issue for many families than this one for us to resolve. for me as a former chairman of the oversight subcommittee, and you as the current chair, we have learned from a lot of masters that have come before us. this subcommittee has been important to investigate over the years goes wrong, identified, then come back with legislation to fix it so it does not happen again. i'm actually in sturgis, michigan right now. i spent much of the morning here for a couple of hours i was at the closed habit facility, talking with the vice president of nutrition supply chain and a number of employees that have been there. some that have been there for generations. families that work in there, some as long as 40 years at that facility. i have been there a number of times over the last number of years. because i was not able to hear the witness's testimony or really have, listen to some of the answers to the many questions posed by both sides of the aisle on this. important topic, i will say this and i appreciate dr. caliph's input. -- dr. califf's input. as i understand it you responded to our colleague billy long, saying he thought on a scale of one to 10 your performance you saw was about a four. you and i talked a couple weeks ago as this facility remains closed, and one of the things you told me is that, frankly, the fda needs more resources to make sure these food safety operations are safe. when chair to get and i -- chair degette and i work, we give the fda more responsibility. the fda need more resources and we did that. last week, of course, the house passed $28 million in additional resources for the fda. i would imagine the senate may take that up at some point too, whether it be this week or the first week we are back. my question, dr. califf, is that if that money is approved and signed by the president, and you tell us how you are going to use that $28 million? dr. califf: first of all, we appreciate what the house is done. also appreciate what two of you did and your colleagues for 21st century cures. it has made a dramatic inference on the medical products site. on the $28 million, it is obvious from the discussions we have had we need more people that can ensure the quality of the imported infant formula, who can review the applications and get them done, and inspectors to investigate and do the testing that is needed to make sure that this surge in infant formula that is going to occur happens in a safe way. as we said before, we will scrape together into it somehow without the money, but something else will suffer, and we need the dedicated funding to make this happen. have also talked about the information technology. the money allocated is a drop in the bucket compared to the ultimate need, it will at least allow us to patch together. -- paginated together. >> is a set down with abbott this morning, i would like to share this with my colleagues. it does appear -- first of all, and has been shut down since february. they made massive changes in -- inside the facility in a number of different ways. they have shared that with the fda, but they also have a third-party group to in essence certify and comply with the demands the fda has made. and they intend to have the facility, as you indicated to our colleague, that it will be up, but if they don't meet, it will be later than that. they're going to make sure they are 100% for that plant is open. their senses is that if they do start on the fourth they will be able to have product and they are to pearl ties the products -- prioritize the products, working closely with the fda and white house to ensure some of those allergens are taking care of, they intend to see that supply chain be fully committed and on the shelf as early as the end of june, probably the 20th or 22nd of june, assuming they start on the fourth. again, glad to share my, i guess last quick question. dr. califf, would you be willing to come back once this plant is up and running? would you be willing to come back and walk the floor with me to make sure it meets the test that all of us want to see it make? dr. califf: absolutely. i love to visit facilities and would be glad to make a home visit with you. it is the great thing about america, the way it works is you are there on the spot, this is your district. in fact -- the fact you can be there in person is a critical part of the effort. rep. degette: thank you. dr., we need to move on. i want to thank mr. upton. i understand you are in the committee room? >> yes, thank you, miss chair. thank you, madam chair for holding this hearing. i have gotten a number of calls from constituents who have had a problem getting access to infant formula. and as we have heard, people on wic have been heavily impacted. my district, which is heavily working-class, and many parents on wic are really feeling this impact. they are appreciating this hearing and responses and they want to know what happened. dr. califf, we have heard today some of the -- my understanding is that people, leadership, lack of money, lack of technology to name a few. i want to talk about the position of deputy commissioner for foods at the fda. my understanding is that during the obama administration there established a role of deputy commissioner for food at the fda in 2010. and that in 2018 the prior administration that position was effectively eliminated. and dr. califf, you are an unaccomplished audiologist with expertise on drug and medical policy. i'm concerned there is a lack of similarly-accomplished individuals leading the fda on food safety and the food program, which may have also led to this shortage. do you think that we need a deputy commissioner for mood to be reinstated at fda to ensure another infant formula shortage doesn't happen? dr. califf: i appreciate that question and i know a lot of people are asking it. i would respond like this. when i came through in 2016 as commissioner i had steve austria off, who had been acting commissioner, who then moved into that seat. and it was reassuring. then changes were made by dr. gottlieb and, you know, i have talked with him about why those changes were made. now i have come back again. as i tried to make the point, there were deputy commissioners, and these problems we are describing are systemic and they were not fixed. i don't think it was because those are bad people, but my point is there is more to it than having a person in that particular job. what i'm trying to do over the next few months, i had planned to do this at six to nine months into my administration. we will move it up now. what i plan to do is look at the whole thing. and whenever the right structure is, you also know we have had multiple commissioners between, which changes things on and off. i would like to put in place a structure that will last, that people have confidence in. in general i agree that we definitely need a stronger team at the higher levels on the food side as part of the revamping of the entire food program. rep. barragan: we have heard some of the deficiencies at fda and generally we have heard about some of these. is there anything specific you think congress should be doing to prevent this from happening again? there are a lot of things that went wrong here, and it seems that sometimes we get these solutions in generalities instead of specifics. dr. califf: we have a long list of specifics. we have gone over a number of them today, but we will be glad to compile those into a list and make sure that they are right on hand. there is this period where the user fee act -- and a number of them are included in that legislation as a possibility. rep. barragan: thank you. my next question is about the structure. who would you say is in charge of food safety at fda? dr. califf: no, i have been a part of many organizations, health systems, academic centers, as this is, and almost all of them in modern times are matrices, which means you have some people with specific responsibilities. in this case dr. mayne is the authority in nutrition. how organizations work and scientific management. mr. yiannas is the authority in supply chain, how the industry works, and knows that. they have their specific responsibilities. rep. degette: thank you, doctor. let me go to dr. mayne since you mentioned that. dr. mayne, would you say you are in charge of food policy at the fda? dr. mayne: i direct the center for food safety and applied nutrition, so i leave that initiative that includes all of the scientific operations within the center. there are other components, as you heard in our organization. we work with deputy commissioner yiannis, who has oversight with the upper canned response, as well as other high-priority areas, such as the area of smarter food safety. and we work with the deputy associate for affairs. rep. degette: thank you, doctor. my time has expired and i think the responses show i don't think there is one person that is responsible. it just goes to show that there needs to be restructuring and needs to be more clear who is ultimately responsible. i yelled back. rep. degette: i think the gentlelady. mr. bushong is also in the committee room. you are recognized for five minutes. >> thank you, chairwoman, and i appreciate it. i want to say, i think you for your professionalism and coming in answering the tough questions in front of the subcommittee today. i very much appreciate that. i am disappointed that it appears the leadership of the sturgis plant does not appear to have an employee-driven health and safety program in place, or they didn't listen. food manufacturing facilities i have visited in my district and state have these type of programs in place. columns are addressed quickly. with -- a climate of culture and collaboration is in place. why did it take a whistleblower? the fda also clearly needs to be more nimble. and may need some operational restructuring. in addition, the noncompetitive, inflexible marketplace in infant formula needs to be thoroughly evaluated. dr. califf, with respect to additional resources and staffing, according to a recent letter sent by house appropriations chair delauro, during fiscal year 2019 congress funded 2179 full-time positions for the office of regulatory affairs. but oh allright allocated only 375 positions for food safety and inspection staff. at the end of the 2019 calendar year this may have changed. that is why i'm asking. over 100 of those positions were vacant. again, why are additional resources needed for staffing if the fda has not filled the positions it already has funding for? dr. califf: i think you are asking a good question. i will have to get back with you on the details of the updates of exactly where you are. i would emphasize, this is a place in 21st century cures on the medical side we got authority to do the hiring for these very technical, scientific jobs, which are difficult to recruit for. it takes us much longer to fill the jobs on the food side because we don't have the same hiring authorities or the same ability to pay. so we very much need that in order to fill these jobs. your question about the intersection of the requests we currently have? rep. bucshon: i appreciate that. it is clear many federal agencies need to update their technology. i understand that, and maybe that is where additional resources should be allocated. i just think from a congressional standpoint, just blanketing the fda with more money without specific line item things that need to be addressed is the wrong approach. the fda's testimony notes there are hardcopies of whistleblower complaints sent to three fda officials, including dr. mayne, were not forwarded from the fda mailroom. literally they were blaming the mailroom, which could be the case, but we are in 2022 here. despite the mailroom issues, according to the fda's testimony and timeline, some fda officials did receive the whistleblower complaint in october 2021, there be via email or fedex. and still, dr. mayne and dr. woodcock did not receive copies of the whistleblower can claim -- whistleblower complaint until february 2021 by email. again, why did it take four months for dr. mayne and dr. woodcock to receive copies when other within the fda already were in receipt of the complaint? it seems to me this was a process problem here and not necessarily a funding problem in this area. dr. califf: this is a bigger issue, as i have stated before, is a significant process issue, of escalation criteria within the organization, which we have now fixed. people were working on the complaint and did not escalate it to the three leaders that you have discussed who really should have heard about this earlier. again, i'm not blaming the people, because it was not standard procedure at the time to do so, but in retrospect it would have been much better to do it. the hard copy will be publicly addressed, but it is a technical issue and we are fixing the mailroom as we go. rep. bucshon: is the reason these were waiting for hardcopies, is it a privacy issue as it relates to emails? or that type of thing? in medicine, with hepa, hospitals a lot of times will not -- they want you to facts stuff, because it doesn't go into the cloud and it is gone. is there a substantial issue there also? dr. califf: i really don't believe that is the issue in this case. it was just standard procedure was not to escalate. people were working on it, they just cannot let the leaders know. rep. bucshon: i appreciate you coming to the committee today and being professional about it. knowing that you were kind of dropped into this situation only a few months ago. i yelled back. rep. degette: thank you. i think the general meant. the chair now recognizes miss rochester for five minutes. >> nikki for holding this important and timely hearing, and thank you to the panelists for helping us better understand this crisis, particularly what happened, what is being done about it, and how we prevent this from ever happening again. delaware is among the hardest-hit states in this infant formula shortage, and protecting the health of our nation's children is a responsibility i take very seriously. as families find empty shelves at grocery stores, i am particularly concerned about reports indicating that scammers and counterfeiters are trying to take advantage of parents and caregivers' desperation, further putting the health of babies at risk. dr. mayne rec the fda is aware of these scams and give advice on how parents can recognize and avoid counterfeit problems. commissioner, is the fda coordinating with other agencies such as the department of justice to end these scams and hold scammers responsible? dr. califf: we are, yes. as we can, but we have very limited resources, and as you correctly note, we do not have our own capability of enforcement. the justice department take on the case. so, it is another area, perhaps for another day, to spend time on. with the increasing availability of the internet this is a big concern, and it is especially concerned because you have a history. melamine from china, for example, the cost problems. parents have to be careful. >> you preempt in my next question, which was, does the fda have the resources it needs to effectively coordinate with other federal and state agencies to combat these scammers and remove the counterfeit formula products from the market? even additionally to pat, you know, from the resources -- to that, you know, do you have the resources? it sounds like something you would have to get back to us on, but specifically we are looking at what resources you need to coordinate with these agencies. what funding authorities or flexibilities be helpful? dr. califf: i really appreciate and we will get back with you. i wish everyone could go with me to the mailroom at jfk to see what comes in that americans are buying internationally that is quite dangerous. we have very limited capabilities right now. we are doing all we can with it. >> we would love to follow-up with you on that. in your testimony you note that the wide-ranging impacts of a recall from a single formula manufacturing facility underscores the risks and vulnerabilities in the supply chain when production is consolidated among major manufacturers. the bipartisan supply chain resilience subtitle of the america competes act i am leading would incentivize as this is to diversify their supply chains and prioritize investments in small and medium-sized manufacturers. how could incentivizing businesses to diversify the infant formula supply chain and increased reliance on small and medium-sized manufacturers enable the industry to better withstand any future disruption? dr. califf: as i think you know, i love this question because it is so critical and essential to the future of america. with digital technologies now there is no reason we cannot keep track of supply chains the matter where they are, and in a world with climate changes and with cyber warfare ongoing all the time, it needs to be the case that if you have a critical plant in michigan, would have a second or third plant at a distant side and have digital connections among them so the second one can be activated when needed, or might have adjustment of production according to needs. the case we have in front of us also emphasizes international supply chain management, because -- and i think it exemplifies what you are saying bring it to america, that is an important part of what we need to do, get to america. we need to have digital control of supply chains on an international basis. rep. rochester: i want to thank you for your testimony and also for the answers you gave to all of us. you can see this cuts across our parties, every state. it is for the future of our country and i really appreciate it. i am also glad you bring your private sector experience to solving these problems as well, so thank you so much for your testimony, andy, i yield back. -- and, madame chairwoman, i yield back. >> thank you, madam chair, and thank you for allowing me to wave onto this subcommittee. and thank all of the panelist as well. commissioner califf, i am a pharmacist, a health care profession or, -- professional, but even more importantly i am a father and grandfather. this hits home, literally. my youngest granddaughter is six-month sold, and she is on infant formula. we have a family text chain we send around, and my wife had sent a picture of the infant formula to everyone all across the country. if you see any, by we need it for mary and mm. that is how real this is, and i know you recognize that, but i want to drive home the point that this is impacting all of us . and, you know, it just appears that the administration really didn't pay any attention to this until it hit the media. i mean, granted that what happened in michigan with the plant was crippling, but at the same time this has been building up for a while. so i'm disappointed in the lag and time it took to respond to this. having said that, i will say that i have always believed it is never too late to do the right thing. and when the president did invoke the defense production act, that was a good thing. as i understand it, that is going to speed up the manufacturing of u.s.-made formula and would require the suppliers to send the necessary resources to the suppliers for other customers who have requested those. what specifically do you identify those resources, commissioner? in the defense production act, are those resources identified and ordered to make sure that we have that capacity and make sure they are getting to where we need them to be? you are muted. dr. califf: sorry about that. i don't know why it mutes and it's when i don't touch it, anyway, i was going to say you are from georgia, i am from south carolina. i appreciate the opportunity to wear a seersucker suit coming up. in a formula there are 30 constituents that have to be there in the right amount. this constant communication with manufacturers about what they need, i would like to ask dr. mayne to make an example of the kind of thing we are having to deal with with infant formula. dr. mayne: thank you, and, yes, congressman carter, what we have seen is first the strain of their covid-19 pandemic, then the strain of the recall, and now we have the russia-ukraine conflict. you know the ukraine region is one of the world's guest exporter of products like sunflower oil. sunflower oil is used as an ingredient in many products, including baby formula. we have been working with manufacturers should they be unable to maintain their supply of sunflower oil what they would replace it with, and make sure that would meet the requirements for infant formula. it has been a constant dialogue with the manufacturers. what do they need and how can we make sure they get what they need to make these products the utmost priority? rep. carter: i appreciate knowing that. that is a great explanation and i accept that explanation. hopefully it is going to result in more u.s.-made product as soon as possible, because this is an immediate problem. let me ask you this now. we are not going to inadvertently impact other areas or other production of things that are needed with these products by invoking this defense production act we? dr. califf: well, i'm going to ask dr. mayne to also comment again, but let me say it is entirely possible, which is why it is critical for everyone to realize the complexity of the supply chain group that has been working across government ever since the pandemic. this is what you call the cheap suit phenomenon. you fix one thing, then the other thing gets out of whack. this has to be looked at. dr. mayne, is there anything that comes to mind about that? dr. mayne: we have considered that. and like sunflower oil provides essential fatty acids we need in infant formulas, and we want to per euro ties it there. it is also used in products like snack foods, where they could replace other oils that would work from a technical point, but are not there as a sole source of nutrition. the prioritization is done based upon the nutritional priorities of these products. rep. carter: ok. well, thank you very much for your efforts. madam chair, thank you for allowing me to avon and i yield back. -- waive on and i yield back. rep. degette: thank you for joining us. you are recognized for five minutes. >> think is so much. we are in graduation season back in florida's ninth congressional district. the pandemic has reached havoc on our supply chains, including infant formula. consolidation of industries to three or four major formula manufacturers has made our nation vulnerable. at a recall -- add a recall, and we see a major infant formula shortage. congress' greatest responsibility is to the health and welfare of our children. they are literally the future of our great nation. congress is responding with action. we passed a law to boost wic, the program to help source more formula for low income families. i think president biden for invoking the defense production act, tear left a major shipment of infant formula -- multiple shipments -- to the united states. and never -- and i appreciate republicans' outrage at the hearing today, but where were you when we voted on the 28 million dollars in fda funding? thanks to mckinley for your partisan vote. the rest of you sadly voted no. we want to all make sure the sturgis plant is reopened quickly, and that takes more resources. that is why that vote is so critical. the fda is shortstaffed, and this is causing further delay. it is time to work on this in an -- a bipartisan manner. dr. califf, the house just voted on an fda funding package. as the fda -- is the fda shortstaffed in the food area and would this help us long? -- us along? dr. califf: the short answer is yes. i would like to make a statement about the employees that have been working hard on this night and day, getting very little sleep, very talented, but they're just not enough of them. we really do need to increase the staffing. rep. carter: -- in line >> ma, commissioner, we are going to put our money where our mouth is. we are going to get you additional funding to make sure we have those extra resources to get that plant up and running again safely and efficiently. we are also going into a conference, the american competes act, where we are looking at a host of items that are critical to national security and helping with our supply chain, boosting domestic production of critical goods for our national security, our families. medicines are part of that negotiation. when diversifying our infant formula manufacturing through the america competes act help prevent shortages like this in the future? dr. califf: absolutely. i'm privileged to be a member of the national academy of medicine and served on the resilience committee. i had to resign when i was nominated. that report gives every bit of the case you need that we must diversify not just in the u.s., but also in our international efforts, and we need to link it with digital technology to make sure we can get the the right places at the right time. >> i will yield back. rep. degette: the questioning has ended but i deferred to the ranking member, if he has the last question or so. >> yes ma'am. rep. degette: you are recognized. >> thank you. it is interesting that my colleague, mr. soto, referenced that some of us did not vote for the money last week to send to the fda and the fda indicated they need money but charwoman up appropriations sent a letter saying the congress funded 2000 positions 40 ra. the or a only allocated a few positions for inspection staff. i remind everyone that someone -- sometimes it is good to have these hearings. we don't need to throw money at it. i would like to ask commissioner caleb, we know there is one infant formula product that you have approved and enforcement discretion in -- on it. how many other enforcement discretionary requests are therefore infant formula pending with the fda? dr. califf: this has been an tremendous response and i will turn to dr. maine. dr. mayne: it's we announced our regulatory flexibilities, we had a webinar of industry. we explained the data and information we were seeking and we asked the people -- people to apply if they have product available that will meet our standards. we have 2600 people who apply to the portal. one of those was approved. rep. griffith: thank you. rep. degette: i have one final question. everyone talked about this issue about the bacterial strains that were found in the infants that were sick and the ones that died did not necessarily mask the strange -- match the strange that were found in the two inspections in the facility but i want to make sure that we don't leave anyone with the impression that that means there was no contamination of the facility or there is no problem. can you talk of been -- again about the problems that were found in why it was necessary to take the actions the fda did? dr. califf: the absence of being able to prove there was a connection does not mean there was no connection. we cannot bullet in or out -- will it in or out and when you make a conclusion there is a connection, that is major and you have to have the evidence. we don't. that clued us in to what we have do. let's say you had a next-door neighbor who had leaks in the roof and did not wash their hands and had exterior in the kitchen. there is standing water on the counters and floor and the kids were walking through with much -- mud on their shoes. you probably wouldn't want your infant eating in the kitchen. that is what the inspection showed. i think abbott is on the way. i am optimistic that we will get over this to people. we are -- they are hard-working people and we don't want to castigate them but these are the facts that we saw. rep. degette: thank you so much and thanks to you and your team and all the members. we appreciate it. we have a second panel in the chair will announce that we are going to take a very short break for 10 minutes and we will reconvene at 2:05 p.m. eastern time. thank you very much. >> taking a break in the hearing, house members hearing from the commissioner of the fda and representatives from baby formula and effexor's. we will ring you back to the -- bring you back to the hearing as soon as it returned. rep. degette: the subcommittee will come to order. the committee is holding an hearing and tile formula, safety and supply. today's hearing will examine the nations product recall, shortage and steps needed to increase supply and further action we need to do to make sure families have access to safe formula across the country. new to the covid-19 emergency, members can participate in today's hearing either -- in person or online. for the members participating remotely, your microphones will be on mute for the purpose of eliminating black round -- background noise. you will need to you your mic each time you need to speak. once you on mute -- unmute your microphone, it is subject to be heard by the livestream. because members are participating from different locations, all recognition of members will be in order of subcommittee seniority. documents for the record can be sent -- with the actors we provided to staff and all documents will be entered into the record at the conclusion of the hearing. cher will organize -- that's -- >> we expect answers for the fda , abbott other manufacturers on why caregivers are scrambling to find nutrition they need to sustain their babies and children and most importantly, we will discuss solutions to prevent this from ever happening again in the future. the current formula soares has real consequences. babies and children are suffering. parents are nervous. i have heard stories from pediatricians who so malnourished children and i spoke directly to desperate parents who have been driving for hours from door to sore to find formula and i heard from children's hospital -- who caregivers haven't been able to seek formula. we note that this crisis has had a disproportionate impact on of -- low income families and families that rely on special formulas for children with special needs. these are our top priorities in today's hearing. the tragic situation is unacceptable and was totally preventable. there were growing strains in -- on the domestic supply of formula in the months leading up to illness, but the recall -- itself turned the formula surprise into a tailspin. let us be clear. abbott is not blameless. the company appears to have neglected essential manufacturing and cleaning processes that are in place to guarantee the safety and reliability of products needed for our most vulnerable populations. today, the batch of contaminated infant formula that sickened four infants resulted in two of their deaths. the bacterial sample strain of the sample taken from two of the four infants was not found in environment of samples taken from abbott's production facility. alarmingly, the facility has too long of a record of deficiencies, including evidence the same potentially fatal bacteria on site and batches of its formula in 2019 and leading up to the 2021 inspection. fortunately, some batches were hot before the product wasn't -- release for this -- distribution . this presents a disturbing pattern of negligence. one company alone does not bear the entire burden for lending in this current situation. there are questions surrounding the timeline of fda's investigation response from a four-month lapse from returning -- before returning to inspect the facility, delayed connection with a whistleblower, and slow communication to the american people. there is much more to learn about fda's actions. today, we seek clarity on what the agency was doing behind the scenes during this critical time period and what lessons have been learned from the situation. i am pleased the fda and administration have been focused on solutions, announcing a range of actions across the federal government to increase formula for companies in the most special need. that manufacturers are in the midst of these productions, maximizing productions to meet the urgency of the moment. we are also joined by the other two major manufacturers of infant formula in the u.s., gerber and reckitt. these companies have been ring with the biden administration to ramp up production and bringing safe formula into the supply stream to fill gaps. the biden administration's efforts to coordinate this response to get families out of the immediate crisis have been extensive and i think we will see they are working soon. we cannot ignore the need for longer-term solutions. the bottom line is that the fda needs the resources to make sure the food part of food and drug administration is not an afterthought. just as fda works to ensure that life-saving medicines are safe and effective, the agency must have resources and staffing to ensure the food consumers consume is safe and reliable. fda's food safety oversight is resourced at only half the amount of drugs and biologics. as a member of the subcommittee for decades, i will tell you , this is not a new problem. it has been under resourced for far too long. i am pleased that the house passed funding to address the current emergency. a one-time fix is not enough to more resilient food safety for the future. we have to work together to bolster the food safety and the supply chain system not just today but for our children tomorrow. the empty shelves are inexcusable and the stories of caregivers scrambling to find nutrients their children want and need are heart-wrenching. i stand with our colleagues and witnesses today in committing to finding solutions, permanent solutions, for the american public. at this time, i am proud to recognize the ranking member, mr. griffith, for the opening statement. rep. griffith: thank you for holding this critically important hearing. i want to thank the commissioner califf personally for coming to this hearing and responding to a phone call the fda arranged. at the house appropriation hearing last week, commissioner califf said he would be prepared to go into much more details today at our oversight hearing. i look forward to learning those details. many infants in the u.s. rely on formula for nutrition and parents are experiencing anxiety as the country faces an infant formula shortage. no parent should have to worry about how they're going to feed their baby. period. i've heard from folks all over southwest virginia who are having issues providing the most basic need for their infants. the big question is why did the biden administration let shortage become so dire without -- before acting with urgency? i anticipate we with your different excuses today and i'm not interested in debating stock rates or whether babies can switch from one branch to another. i'm looking for answers and long-term plans moving forward so this doesn't happen again. how did we get here and when did it is infant formula -- this infant formula shortage begin? the fda says it has been on their radar since march 2020. >> production, gerber products co., robert cleveland, senior vice president of nutrition of america --and reckett. thank you all and i know you are aware the committee is holding an investigative hearing and we have a practice of taking testimony under all. you have any objections with testifying under all? the witnesses responded no. the chair man advises you, you are entitled to counsel. do you you desire to be a copy -- companies by counsel today? let the record reflect the witnesses responded no. please raise your white hand -- right-hand. do you swear that testimony is the truth, the whole truth and nothing but the truth? >> left out record reflect the witnesses has responded affirmatively and you are under old and subject to the penalty set forth by title 18 -- the chair will recognize each of the witnesses for five minutes to provide opening statements. i would like you to be aware -- is a timer on your screen that will count down your time and i will recognize you, mr. calamari. --kalamar. >> members of the subcommittee, my name is chris calamari and leave --i lead abbott business. i want to express our extraordinary disappointment about this shortage. we are committed to ensuring this does not happen again. safety comes first and the recall work necessary steps to ensure our fun little supply was a. both steps have worsened the current disorders. it will take more time but we want to assure you we are doing everything we can to get more supplies on shelves for families. since ensuring the recall, we took aggressive action to boost supply. we have reworked our global network to create additional capacity in the new york -- u.s. market. we are now up to nearly 50 flights per week coming into 12 major airports across the country. those flights will continue as long as yesterday -- necessary. we have converted other avid - ! abbott. --lines. trying to help replenish supply. we are working with agencies to ensure quick purposes --wic services -- we are releasing metabolic harmless and working with other manufacturers to address demand. we are taking steps to address the issues arising from shortages -- a specialized pharma with children that cannot digest other forms of milk. we are in the process of leasing 300,000 cans of this. we are establishing a $5 million fund for families in need. the end of june, we expect we will be supplying more formula to americans than we were in january before the recall. when we do the hard work to increase supply, we have been inspired by our employees across the country who have done everything they can to get formless into parents hands. employees like sales representatives, kathy, who make long drives to deliver formula. for director of customer service operations lee, who arranged to have formula delivers same day to alaska so they -- it could be air delivered to families of actives duty service members. this isn't about us but about you. you either don't have the product you need or have trouble getting it. we understand the difficult position you are in. we know we have let you down and we will do everything we can to re-earn your trust. we are working closely with regulators to restart production of sturgis, will -- that will increase capacity by 40%. safety comes first. at sturgis, we take samples across our operations to ensure the facility and the product we produce a safe and we regularly test pharma before, during, and after the production process. we will continue to look for new ways to improve because operating a clean and safe plant is a job that requires constant vigilance. we plan to start production at sturgis the first week of june. we will begin with the production of one formula before turning to other formulas. we estimate it will take 6-8 weeks before product is available on shelves. we will learn from this. current supply chains are not resilient enough. we have been a leader of supplying food for families for 50 years and we met -- want to make sure this never happens again. we will expand capacity and redundancy. in closing, i want to assure you we will not rest until we can meet the needs of millions of families who depend on our products. thank you and i look forward to your questions. rep. degette: thank you. mr. fisk, you are recognized for five minutes. >> and q for the opportunity to testify today. i have served vice president and i appreciate the opportunity to discuss gerber's efforts for this shortage. at gerber, are missions -- our mission is anything for baby. as a father, i can only imagine the anxiety for parents who need formula for children now. while gerber is a small manufacturer in the u.s. at about an 8% market share, we are working tirelessly to help parents and caregivers if the formless they need. for 90 years, the quality and safety of our products into well-being of infants has been top priority for gerber. we have stringent controls in place for all levers of commercial -- production and art infant formulas go through safety checks. our standards are strict and many of our measures exceed fda requirements. the infant formula industry is not immune to global supply chain challenges. given our highest safety and quality standards, the highly regulated nature of the industry, adding new suppliers and changing packaging materials is a rigorous and time intensive process. we have based constraints available -- related to labor and transportation. these challenges were exacerbated by the recent recall in the infant formless space. we recognize the radical -- gravity of the shortage and have taken actions to respond. we have increased production of infant formula. our factories are going 24/7 to reduce formula as efficiently as possible while maintaining high safety standards. we want to manufacture products that are most in demand. we have significantly increased formula available to consumers and hospitals. we have accelerated e-commerce availability and air freighting count -- out of produce in other countries and we are releasing inventory to get product to consumers. we increase the availability of our influence formula by 50% in march and april. more must be done and we believe the steps gerber has taken has made a difference. we have partnered with the biden administration on operation fly formula which will ask bullock -- expedite the import of the equivalent of $1.5 million of the specialty hypoallergenic formless. these shipments arrived in indiana. the second shipment arrived today entities being transported to pennsylvania. we are providing essential information about infant formula to parents and caregivers. our parents resource center has been available 20 47. we are working with our wic eight partners. we are proud to serve the states. although we have been taking steps, more work is to be done. we appreciate the efforts by the fda and we recognize that the flexibility. we are looking for opportunities to import more formula. we filed two requests with the fda to import formless. we believe the fda should have the authority to provide radar and test -- transparency, having anticipated impact about recall. so that companies like garber can respond quickly and the fda must also have appropriate work resources to view routine notifications from manufacturers. our mission has been anything for baby and we look forward to continue with all necessary parties to ensure our families are able to feed their little ones. thank you and i look forward to your questions. rep. degette: mr. cleveland -- you are recognized for five minutes. >> you distinguished members. thank you for the invitation to prep -- appear before you. it is an honor to be here to adjust the -- discuss the efforts about the supply shortage. i cover -- we were founded in 1905 as a premier producer of pediatric nutrition and we produce infant and specialty formless with well-known brands. our major manufacturing facilities are in northern michigan and southern indiana. we recognize that the formula shortage is a serious issue and as an father, i understand that nothing is more important in the ability to feed children. we are working and coordinating closing with the government to address the shortage. i am proud of the storm there people at my team whose efforts have exceeded in increasing infant formula by more than 30% compared to this time last year. in response to the shortage, we have all hands on deck around the clock to get products to families who need it. the steps we are taking include this. we have added shifts and unlocked unlimited over time at our plants. we cut our time to market almost in half by having trunks ready to load the minute we will products out of our facilities and we are working with retail partners to ensure that when the drugs arrived, they are the first of the distribution centers to ensure the product gets to shelf quickly. it is not just about more, it is about how fast. we are simplifying the supply chain by reducing the different number of products we make, focusing on the sizes and format that allows to get us the most products out. we are taking these measures while keeping a close eye on quality and safety to ensure we always meet the safety we will take no shortcuts. we have also been working closely with the federal government to take every step we can to end this shortage as quickly as possible. me, johnson, and other formula manufacturers met with president biden, when they missed ration invoked the defense production act to address manufacturing supply shortages and implement operation fly formula, which directs the use of military aircraft to import formula from overseas. we are also working to expedite, review, and approval some of our infant formulas manufactured in mexico. we are also working with the fda on imports from our facility in singapore. we are working with the department of agriculture to make regulatory and administrative adjustments to the women, infants and children or wic program, that will provide wic participants the -- the -- they need and not cause shortcuts. we also suggest a variety of legislative changes to keep this from happening again. we will be happy to work with you and all of those efforts. in conclusion, thank for the sub for the opportunity to do you today about how we can best meet needs of families who rely on formula to feed our children. we are intensely focused on resolving the shortage that is quickly and safely as possible. thank you. >> thank you. it's now time for members to ask questions. i would remind everyone to mute yourself if you are not asking questions to prevent feedback. the chair will ask questions for five minutes. i appreciate at it has taken ownership -- that abbott has taken ownership in parents are unable to find the nutrition that their babies need. i also appreciate that you are doing everything you can to get this facility back up and going, and get production going. what struck me when commissioner kilis was testifying, abbott has a great reputation among congress and the administration, particularly in the drug and device arena. i don't know why this factory in michigan has such substandard conditions when it was inspected in january. i am wondering, as well as all the things you talked about, as companies talk about getting formula out for families, what new provisions and protocols has the company put into effect to ensure that we don't get into a situation like this again, where major production facilities have to be closed down? >> thank you for the question. i was up there just last week, and i can tell you that the staff there, the team there, they make formula as if it were for their own families. after the fda identified observations where we needed to improve and address, the teams have been actively working on taking steps to address those issues. >> maybe you don't understand what i am asking. i know you are trying to clean it up and get it back open, but what additional protocols are you putting in place so we don't have this happen again. ? >> absolutely. we identified clear observations we needed to address. some of those key areas we are improving include in the installation of nonporous flooring, information of improvements across different processes and traffic patterns within the plant. additional training of employees to address some of the observations that were identified. our improvements range from the physical to the process and all throughout the facility. >> are you institutionalizing that for the future, not just to remedies the deficiencies? >> yes. >> maybe you can supplement your answer on that. mr. fitz, in your testimony you said "more needs to be done, much more needs to be done to ensure every baby can get the formula he or she need now and in the future." we all agree with that, obviously. what step can gerber take to be part of the future solution to make sure we never have to have something like this happen again, one of the manufacturers shutting down a key plant? >> thank you for the question, chairwoman. we are a small player in the u.s. market, so 8% market share. our ability to respond to a gap in the marketplace like this is pretty limited. we appreciate the steps the fda is taking for temporary flexibility in importing products so we can tap into nestle's global network and global capacity. we appreciate the steps we are going through with operation fly formula, where we are importing quickly supplies of the desperately needed specialty products we manufacture outside of the united states. >> ok. mr. cleveland, i will ask you the same thing. what is your company doing to make sure that we can more nimbly respond to any crisis in the future? well, prior to this -- it's a great question and a very legitimate concern. just prior to the recall, we should already -- have already file to bring our mexico facility under the authority of the fda so it can produce formula for the usa, and we are addressing that additional supply for the u.s. market. then, of course, we will be learning from this experience and building contingency plans with our other facilities so should the event happen again, we can respond quickly. >> i appreciate your commitment to rectifying this as quickly as possible, because it is -- for my constituents who are driving around for three or four hours to find formula. the quicker we can get that to those babies, the better. i am pleased to welcome the ranking member for five minutes. >> i think you are a good guy and a bad spot. thank you for being here, but i will ask you some tough questions. i do not know if you have more of a ceiling problem or a four problem. when you see similar problems occurring and read the whistleblower report, which says members of your team at sturges were hiding information from your office, the home office, that could lead to some of the problems the fda has mentioned in their testimony, that you know about. seems to me you have a culture problem. what steps are you taking to change that culture and have any heads rolled? >> representative, thank you for the questions. there are a couple of pieces there. first, the culture. the culture problem. i don't think it's a problem, we were there last week and i saw generations of employees who work at sturges with pride, who feed their own families, and they are committed to making steps to improve, or making those steps to address in the plants physical processes -- you also mentioned the observations. we are working rigorously to address them. i think the team's commitment and passion to quickly address them as they are. we are going to learn from this. this has been an opportunity to improve and we are going to do so. >> i understand that you're trying to put your best face on that you can, but after touring a bottling facility and in my district last week, they said, you have to put on these shoe covers. the fda mission or said, that's what they found. your folks did not seem to think that was a problem, when they had workers on the roof, walking around, and then they walked through the production facility with mud on their feet. when you see things like not inspecting the cans at the proper time and food could be getting in the seams later, causing a bacterial problem and you see muddy feet walking through -- it doesn't take a food scientist to figure out that you don't want going through the facility like that someone with muddy feet who just came off the roof. i know you have a problem, but i hope you will address it. if you see any signs of that happening in the future, can you give me a commitment that you yourself will put eyes on that problem and try to rectify that quickly? this was going on for years at sturges. >> yes, we will. >> i appreciate that. when did you first start to see signs of infant formula supply issues? someone's got to go first. you go first. >> we saw an increased demand for products coming out of the covid time period, and there were not increases in formula feeding rates. we saw households buying more, coming out of the covid timeframe. >> is that the same for you, mr. fitz? >> certainly related to this current issue. we became aware of the recall at the same time the general population did. it was the next day, the next week, that we learned about the situation, so we restarted -- >> hang on, next day or next week? what's the timeframe on that? one was coming out of covid -- around the same time, and then you got contacted by the fda. when was that? >> after the public announcement of the abbott recall. >> late february, early march. mr. cleveland? >> yes sir. we had seen an increase in demand roughly from the middle of last year that was contributed to many shortages in consumer package goods at the time, and making sure they had enough infant formula. but the moment in time we are talking about right now began immediately after the recall in february. >> is that the first time you heard from the fda about supply chain issues? >> the fda reached out to us after the recall and began speaking about issues that could be related to it, yes sir. >> do you mind giving a description, madam chair? had you heard from the fda before this? >> we are always in contact with the fda. >> where they talking about supply chain before that? >> they were not talking about supply chain, no. >> thank you very much, i yield back. >> if i were listening to your comments, i would not be very happy right now if i were looking for baby formula. all i have heard you say is, we will get a plan up by june 1 and be able to supply more -- well, we should do something to get this stuff out now. my constituents don't want to wait six to eight weeks, if that's what i heard, and then i heard mr. gerber say, don't worry too much, because we are flying and stuff from abroad. i know the biden administration is doing a lot with this defense production act they have going, but is there anything you can do to speed this up? is there something you have that could come from abroad? i will ask mr. fitz, what does this mean, with hope of working with the administration? can you expect to get to normal within six to eight weeks? let's start with mr. calamari. is there anything you can do to speed it up in six to eight weeks, or do you have supplies from abroad? >> we are daily getting six to eight flights from ireland, our fda facility, and will be delivering millions of cans in the weeks to come. >> how is that good? how quickly can we expect to be getting back to normal, between that and urges? >> by the end of june. we will deliver more product in june then in january, will the recall. we will sustain those efforts with whack it sounds like is still another month and i am not having with that. mr. fitz, urinating stuff from abroad and trying to increase production. we are trying to discuss the end of june? >> we are a small player and our -- is aligned to that. tapping into the global nestle network is a big step for us. we now have access to more of the global and hilly network erling juror wonders supply. we cannot leave it charging much -- >> is there anything you can do to move up this deadline? i will go to the last speaker, mr. cleveland -- is there anything that can be done collectively or with our help so it does not take another month or over to get to a norm for normalcy? >> we are moving and your -- we hope to take advantage of the fda's important exception very, very soon to bring in formula from our manufacturer in singapore respectively, and the defense procurement act, production acts, excuse me, is helping to secure valuable inputs that can help. >> how are you going to get word out this is available? i asked the same questions of the fda administrator. google not know where to go to get this stuff. >> we have information on our website, one-800 numbers, information to guide parents and families to where there might be products and it is updating that information -- >> i would like to get the word back out to us, because i am afraid people are not going to know how to get it. if you could get back to us with that information, thank you. >> the chair now recognizes the ranking member of the full committee for five minutes. >> according to a washington bow senatorial robert ford that we will not tolerate. what was the discovery in the sturges plan? >> thank you for the question. the bacteria in question was found in part of the facility that is not contact with products, wages not acceptable, to be clear. we have taken action to make sure it a problem these in place i will say the bacterial infection in question is, incurring, and we need to casual forage unit is generated to produce -- >> what i can tell you, we have a decade of reviews and inspections at the sturges facility. in 2019, when there was an observation, we quickly addressed it. we have taken action to address these observations, so we value the relationship with our regulators. we have a safety first, prioritize compliance relationship. >> how do you give confidence that evidence is -- that abbott is going to address the underlying causes of this? >> we as a leadership team are fully committed, all resources against it. we want to make sure we put the necessary steps and sustained action in place so this does not happen again. >> when was your company first contacted about the shortage problem from the white house ? >> coming out of the recent announcement president biden has made, we have been trying to get back to supply and working on our action plan from the moment in february and before when we became aware that we would need to get more capacity online. >> you have been working on addressing these issues in february to get back online? >> we have been working on a variety of actions. we have been lifting our product from ireland. in february and march, when we became aware of the recall, that's when we started making the necessary steps of the main fracturing lines to liquid. you want to get this as soon as possible. >> so what's the difference between what you started doing in february, where you are today, and what you will be able to accomplish in the next two weeks? >> we have aligned set of principles we can work with with the fda and make sure we are producing in an aligned fashion. that can increase our capacity versus the previous action by an additional 40% >> how does that differ from the actions you are taking in february versus what is in the consent decree? >> we were working on increasing supply not just in surges related facilities, but this allows us to act in a blind fashion. >> are you taking a variety of actions around the bacteria found in the plant? >> yes. we are trying to improve its abilities and infrastructure and improving from the get go. >> but you have not been able to satisfy the fda get? >> with the consent decree, we are in an aligned position to move forward. how are we going to be able to accomplish this in two weeks, with names like --. >> is a 7000 square-foot facility, so we are cleaning, testing, and validating to make sure every process that is in lace, every quality check is in place so that way when we get up running, we can do it in a sustainable fashion. >> thank you for holding this today. we need to address this crisis. >> sir, you are recognized -- you are recognized for five minutes. >> thank you. here across the country and in new hampshire, families are scrambling for a formula, even falling victim to skim and counterparts out of desperation. by the way, we are all shocked to hear about the conditions of the sturges plant, it was ultimately the safe thing to do to recall the product to ensure the health and well-being of infants across this country. now, it will take and to ride indication for dexter -- desperate families -- disparate families. when specifically did gerber understand that american consumers with experience in -- would experience in a formula shortage and how were you able to respond >> menu her parents, and my inspiration. the u.s. is a small supplier, is as though sometimes i have to fill -- we have to fill the void. we had no idea of the scale or extent of the outage. but in march and april, we supplied an additional 50% of product to the market, which is substantial for all of to increase production past current need. >> would it change your business plans generally overall, and this is hypothetical, but i think it is something we need to consider -- if the wic formula was not a sole source, but if you could participate in that program, would that make a difference in your business model? >> i can tell you, as a small player in the u.s. market, it's difficult for us to compete against two larger competitors. >> if you had a larger potential market, would you see growth in gerber? production of baby formula? >> as you are probably aware, nestle is a large manufacturer of infant formula globally. we saw a market opportunity here, i am sure we would invest to satisfy that need. the opportunity. >> thank you. the biden administration has announced multiple measures to expedite supply chain solutions and get manufacturers from materials needed to get products to market -- raw materials needed to get products to market. how is the fda and white house working to get these products to families faster and how have these products been affected to date? >> thank you for the question. the answer is yes, they have. the white house has been a strong partner since the time we spoke to them. they have been helping us work with input issued we have been having. we had some real victories there and are seeing some inputs where we struggled, and those are freed up and headed to our plants. that is what is needed to ensure we can run those at full capacity. if we can do that, we can supply more to the market than we are today. >> i would ask you a similar question, if you knew you had an opportunity to participate in the women, infants and children program, would that make a difference in your model going forward? >> we are an active participant in the wic program today. we have been supporting it for many years. it's a good program and was challenged during this period of time due to the shortage. to make it more flexible so formula is more available to those participants, because they are the most vulnerable and are our top concern. we have made a lot of progress in that area too. >> finally, american families need to rest assured that companies are not cutting corners as they ramp up production. back to you, mr. cleveland. what is the company doing to make sure your facilities are producing high quality and they for american infants -- safe for american infants, as you up the production schedule? >> it's a vulnerable population. safety must be first. while we have ramped up production as much as we can, we are taking no shortcuts for safety, we can't. now especially. this is our number one concern. >> thank you, madam chair. i yield back. >> mr. burgess, you are now recognized for five minutes. >> thank you. let me just say, an incident got sick. the powdered formula is identified with this. is that correct? >> it was identified within infant illness in september, yes. >> did that set off a series of investigations in your plant? you mentioned things about nonporous floors, a leaky roof -- were there things that you thought, maybe we start to clean some of these things? >> absolutely, we have processes and protocols in place when there is a reported illness. we look to our back trackers that link to the product in question, look at the complaint rate, and we did that in this example. there were no samples from those reviews and processes that there was anything more to the instance. >> fair enough. four weeks goes by and a whistleblower complaint is delivered to the fda. i assume they contacted you straight away after they got the whistleblower complaint? >> no. we became aware of the whistleblower complaint at the end of april when it was made public by congress. >> so between october and february, the fda, not part of your normal quality assurance process? >> correct. i became aware of it in the april timeframe, and was made aware of it by congress. >> it's disturbing there was not better communication. i recognize if something got lost in the mail -- that's absolutely unacceptable. we had the federal level need to correct that. it was said that corona vector isolation should be a reportable incident. is that your understanding, and would you be accepting of that? >> representative, yes. we have processes in place where we signal the identification of run a vector. >> what it can occur in the environment, so it would have to be a corona vector infection in a child, or in a nonporous floor? >> we would support that. we would support that. >> so the whistleblower complaint was not made immediately available to you. but when it was, was it your decision then to proceed -- ceased operations at the plant, until you got the difficulties directed, or was that an fda decision? >> regarding the fda complaint, it's an ongoing review and an ongoing investigation. given the independent nature of that inquiry, i would not want to speak to that. but i can tell you i have been at abbott for 17 years, and the avid i know prioritizes compliance and encourages employees to speak up. >> and that's what you would want. in my professional career, i dealt with abbott, johnson, gerber, so i have an understanding of your clients, your patients, but things did not quite measure up this time. in the decision-making chain, when did it become obvious to you they were going to have to close the sturgis plant or halt the sturgis plant? >> we agreed to a voluntary recall in the february timeframe. it was with the information we had at the time with the unknowns and given the nature of the patient population, safety, first of all, is important and the most critical thing. looking back now, would we have done the same thing with the information we had at the time, that was in the february timeframe. >> but this says complete cessation of activity at the plant, correct? >> it would have been in the mid february timeframe. >> i would be interested in how you notify the downstream consumer and the other participants of the supply chain that this unfortunately was occurring and you needed to be prepared for it, but you came to submit those in writing. >> ms. rice, you are now recognized for five minutes. >> let me continue along the lines -- i want to clarify, you were informed of the whistleblower in your report. they went directly to another source, but did not go to you, is that right? with the problems? >> yes. i would have become aware and the problem timeframe. >> what system do you have in place to ensure things don't happen like this, and you are leaving it to a whistleblower to bring it to the federal agency's attention before you even know about it? what are the procedures you have to ensure you find out about these problems first, through an oversight program that you implement? >> i think it's a very key area you are commenting on. we do have a process in place where employees can raise their voice and speak up. >> what is that process. >> is independently administered, so it respects the confidentiality of the employee and is administered with oversight. it can be independently administered and review. >> are people aware that they have the outlet to report things in a facility that are not right? >> yes, they do. we encourage employees to speak up and safety is a top priority. >> why was this not brought directly to your attention? >> the nature of this process is, when it was made public, was cleared with fda and i was not aware of the investigation until that time. >> my question is, if what you are describing as a specific program to allow employees to go directly to someone within the company to register an issue with something that is going on in anymore more of your facilities, what happened here? >> avid did not foot -- abbott did not find out about it until it was made public at the end of april, and it was the particular individual who raised the complaint, it was their choice to use that mechanism. >> what are you going to due to ensure that people go to you first and not take the steps they did here? these steps have happened at your facility. maybe not this specific thing leading to an incredible shortage of essential nourishment for babies, but why did your system failed here and what are you going to do to make sure it doesn't happen again, that there is quality with control within your company that employees respect and believe are going to be affected and not come back on them? >> we encourage employees to speak up, to raise concern. >> do eur -- do you offer any reward to people so they do not fear coming forward to higher-ups in the company? >> we re-encouraged by enforcing that their voice counts, that we have a zero-tolerance policy for retaliation against these types of complaints, and that's our commitment, to support their voices and to speak up. >> so it failed. clearly you are not getting the message out to your employees or you would have been aware of this before anyone else was. is that correct? >> i think is important that we use this as an opportunity. the individual chose to raise their concerns in this manner and we have to consider how we reinforce we are a customer --. >> is that something you are aware of now or work before asking these questions? that's something you have to work on in your company. >> absolutely. we are committed to those principles. >> the chernow recognizes mr. long for five minutes. >> thank you, madam chairwoman. for mr. calamari, prior to the recall in february, how much formulas made in your facility? >> -- >> and how much did your company produce formula or account for of the market share? >> about 40%. >> and what share of the market did your formulas product account for? >> we represent about 8% market share. >> i'm sorry? >> we represent about 8% market share. >> 8%? ok. for mr. cleveland, what percent does the product account for? >> we were 34% of the u.s. market before the recall. >> has that changed post recall? >> a lot of consumers who were no longer able to use the abbott brand switch to ours and we are now 60% of the u.s. market. >> i think you are asking the same question of us. the market share has inched up about one percentage point, so we are 9% now. >> ok. same question to both of you. >> does the gentleman yield back? >> ok. >> you are recognized for five minutes. >> i have to tell you, mr., mari , what happened at the sturgis plant and the impact it was about to have. when we have all listen to this, it's discussing, what we heard, water leaking from the ceiling and things that could lead to a cam and nation -- contamination, and i don't know --, so i'm not surprised it will take some time to get your act together and get the place cleaned out. i also heard your apologies, and i just want to say something -- you don't owe one to this congress, you owe an apology to the parents of children who got sick and possibly a couple that have died, and to all the families out there who are struggling and suffering because they cannot get the product you produce so much of. i think, in fact, probably too much of it. we talked a little bit about the concentration of power. mr. calamari, i also note that we talked about the whistleblower that abbott -- i will talk about that in a second -- but avid only took action to recall the formula after the fda learned that more babies have become sick and after four babies were already sick. it looks like two died. i want to ask, mr. calamari, the whistleblowers suggest that the safety and quality have not always been at the top of your agenda. i want to ask you, will you take responsibility for your current employees, to make sure they comply with the fda and the safety requirements for infant formula? >> yes. >> i also want to ask -- let's see -- mr. -- i'm sorry, ok, mr. cleveland, reddick has been working with the fda on ways to expedite the appropriate behaviors. i am wondering if you could tell us a little bit about what you are doing, especially in the mexico facility? >> thank you, madam. the mexico facility has been making formula for latin american infants for many, many years, and grown thousands of babies helpfully and successfully with quality formula. just before the recall, we were going through getting that plant certified by the fda. obviously, since the recall, we have been working with the fda on when we can address the timeline and approval, so we could fill the shelves. that's an ongoing process and the fda is moving quickly with us on it. we are also taking advantage of the fda's import exception to get approval to bring up product from our plant in singapore, which has been making formula for children throughout asia for many, many years excessively, and we think could go a long way with helping with the shortage here in the u.s. these are active conversations every day with the fda on how to get those options in line and moving very quickly. >> thank you, we are looking forward to that. mr. fitz, how is gruber coordinating with the fda to ensure that these products are delivered to american families without compromising quality and safety standards? >> thank you for the question. certainly, the current urgency is there and we have already applied for two requests for fda , the ability to temporarily import products from a german facility, which makes this all european in global markets and we have submitted those applications in the vast week. >> thank you, and thank you, madam chair, for your indulgence. i yelled back. >> you are recognized for five minutes. >> i want to lay out some things here, mr. calamari, that i will ask your response for in a moment. but in 2019, atherton found a deadly positive and in your products. it also concluded inadequate testing action was being done i your surgeries -- i think you see 16 of those between 2019 and 2021. there were no inspections between 2019 and 2021 by the fda or michigan. despite that, 2021 inspections, when they did some, found various violations, mishandling raw materials, mishandling packaging and equipment, failure to maintain clean and sedentary conditions has been mentioned several times in this hearing and the previous panel. what's interesting to me, when the inspections finally started, the pattern of the fta was routinely surprised, -- fda was routinely surprised, but a bbott was not notified. were you notified that the fda would be inspecting the plant? >> each year, we anticipated a schedule -- >> that's not what i am asking you. did you get notified that the fda was coming to that facility? >> no, i was not. >> all right. i will follow up on that later. it's not the usual manner that the fda does these inspections. the others are soothing about the inspection, those these issues were never identified, they were not included in the fda's report. i am wondering if there is a conversation between abbott management and the fda in regards to what the inspection found. was there a discussion between abbott and the fda about the problems at the plant? >> i am not aware of any such discussion. >> were you aware of these issues before the fda inspection? >> i personally was not. >> what you have been? >> our team's surges would be working other processes and steps necessary to produce satisfaction. >> can you give us who might have had access to the information, who might have known you had issues with mishandling of your packaging, materials and equipment? who would have known about the complaints, who would have known that the coronavac are -- that you are not doing product safety. can you give us the names of -- [inaudible] >> representative, we can follow up with that information. >> wouldn't be appropriate for the committee to officially request the >> the witnesses are always requested to answer questions submitted by the committee members, so they will be asked to do that in due course. >> my concern now is that we have a major problem, not just with the supply chain, this is a failure across the board. you testified that abbott represents about 40% of the products that is out there, which is close to 50%. so why didn't avid immediately address these issues -- abbott immediately address these issues without having to be told to by the fda or anybody else? >> we prioritize safety and compliance in our plans and we are committed to doing so and getting better coming out of this. >> for the record, i am not satisfied with the witnesses' answers. i yelled back. >> thank you. you have five minutes. >> this morning shows supply challenges existed prior to the february 2022 recall and the sturges facility shut down. pandemic range to other -- rates in 2021. they have a longer-term resiliency of the supply in the united states. mr. cleveland, you reference the continuing supply chain challenges connected with the covid-19 pandemic and your testimony. what kind of measures to the company employed to try to mitigate the impact? >> in this regard, we are not different from most manufacturers in america. supply chains are complex, with their old going mobile. this could be anything as packaging problems, certain oils that get into our products -- it is complex and changes on a regular basis. we have been able to keep production flowing and keep implementing since the recall because of heroic efforts from our procurement team. when any of these numbers appear , they seek input as that can, do the one that we are not able to get. we could have produced more if we had a constant and steady stream of input. the white house has been very helpful, the administration and helping to secure inputs in the midst of this crisis. >> is back here, the company has had to. >> what ever has gerren taylor in -- what effort has gerber taken in their supply? >> we have strolled, with material supply issues intermittent -- struggled with material supply issues, intermittent material supply issues. we have struggled with quality issues related to the pandemic and had logistics issues, getting trucks and truck drivers available to move the products and supplies that we need. we have had covid related labor challenges and higher turnovers than normal, with all anything that happened with us. we are trying to put in more robust business continuity plans in place for critical components and what we will have challenges in in the future. we have had conversations about the supply concerns as the challenges grew over the past year. all three providers testified having coordinated with the biden administration and piece it -- in recent weeks, but what about last year? did you engage with any talks regarding the growing supply chain concerns, regarding abbott's recall and the plant closure? >> i don't think we highlighted these issues in particular. they have been intermittent and periodic and different every time. we have wanted to solve them and resolve them and continue to produce. >> do you think the fda should be notified or is at least aware of your struggle? >> should fda be aware of our struggle? yes. it shares my concern for the supply chain. >> we will help. he is looking to do that. >> as i have testified, the issues that have come up for us, we have been able to resolve. the last six months, our stock rates have averaged 68% >> retailers do address potential disruptions -- >> we reached out to our retailers to discuss with the significance of that would be. we made sure we had all the existing inventory available to us to push out to those retailers and encouraged them to push their inventory to shelf as well. since then, we have been working to increase flexibility of the programs read the wake consumer -- to increase the wic consumer's needs. finally, we have increased our efforts in manufacturing so we can get that amount to shelf much quicker. >> my time is done, but if you could respond in writing about efforts it you have taken arch -- about efforts you have taken in march. >> we recognize it is important we hear from industry manufacturers as well as government regulators and this whole process. to that end, i asked all three of you, mr. calamari, mr. fitz, and mr. cleveland, could you weigh in on the following question? we have heard about regulations, the supply chain, but my question is going to take a different approach to this. i need to know what effectively government can do right now to ease supply constraints and in the past interview, what regulations could be modified to ease or increase infant supply? how do we get to that point without compromising the safety of the product you produce? mr. fitz, i am going to start with you. if you could change or make recommendations for this oversight committee to increase in the formula supply for the families, the children that rely on them? >> that's a good question in the current situation. the steps the fda is taking to allow temporary flexibility, we are importing products from manufacturers overseas that are approved in foreign countries, as we are doing. that allows us to tap into a global network and respond to the situation at hand. >> we talked earlier in the hearing today. i agree that as a viable solution. i represent a rural area in pennsylvania and i want to see how the rural area can be supplied with that as well. mr. calamari, i respect you as a leader. can you address what you feel can be changed for increasing to feel the shelves? >> i would characterize two key areas where we can continue to improve. one is securing ingredients. the road ahead as we think about continuity of supply, we have to make sure we are prepared for that. making sure to secure supply and ingredients. and, distribution. never cutting quality steps. never cutting testing steps. making sure we have accelerated distribution and ability to get to the customers and consumers. those would be the areas i would say we needed now and will continue to need in the weeks and months ahead. rep. joyce: address that further for me. in the supply chain, are there specific ingredients you feel right now are challenged? >> on the horizon we see agricultural oils absolutely essential. paper is absolutely essential. the cost of fuel to distribute the product is essential. i would call out those key elements ranging from agricultural oils to the cost of delivering the product. those would be the biggest areas of focus. rep. joyce: i appreciate it. now, our final panelist. what as far as government regulation, mr. cleveland? i used your quote about filling the shelves. i stopped this morning at a local supermarket. you are right. the shelves are not filled. parents and caregivers are concerned about that. how from a government point of view can we, without compromising the safety of your product, how can we work and what regulations can be modified to ease what you are facing now? mr. cleveland: i can add incrementally to what has gone before me. many of the suggestions that ourselves and i am sure other manufacturers have made to the administration and other parts of the government have been implemented. so, focusing on those most at medical need through the import exceptions, i think, is an excellent idea. then, making sure that we increase the flexibility of the w ip program to make sure that vulnerable women and infants in that program are taken care of and they have safe access to product. i think the usda has implemented at this point all of our suggestions to do that. it has been very helpful. one final thing i will end on is logistics. agricultural oils is a good point. that is an essential input to our products. we find that the logistics of getting those from our supplier to our plans with sufficient trucks has been challenging. so, it is not just the input. it is also getting to trucks and logistics in place. rep. joyce: thank you for the comments. madam chair, i see my time has expired. thank you for the important hearing today. let's mr. root -- >> mr. ruiz, you are recognized for five minutes. rep. reed: -- reppo ariz -- rep. ruiz: i am concerned that those most affected are those already living meal to meal with food insecurity. that is particularly true for families that rely on the special supplemental program for women, infants, and children wic program. it is essential to the impact on low income families. as i understand it, abbott contracts with a possibly 34 state wic agencies and services 37% of the children receiving wic formula benefits. when abbott's products were recalled, caretakers already in vulnerable positions filled the products absent from the shelves the most. mr. calamari, as the primary supplier of infant formula for wic beneficiaries, does your company have obligations to these families? what actions has abbott taken to ensure that its non-recalled products or competitor products are available to these vulnerable families? mr. calamari: we take our wc -- wic very seriously. we are airlifting similac from ireland, the number one product we provide on the uic program. we prioritized that early in our action program and will sustain that in our action plan going forward. in addition, we have paid competitive rebates. in other words, when our product is not available we will pay rebates on other manufacturers' products so families can get access to the nutrition they need. going forward we will send the rebates through august. it is a scenario we will continue to look at as we think about improvement going forward? rep. ruiz: how to educate the families? do you provide information in spanish? mr. calamari: we provide materials bilingual and work with agencies to make sure we are providing the necessary current status to their constituents. reppo ariz -- rep. ruiz: mr. cleveland, according to company statements as of 2020 reckitt held the wic contract in 15 states and was providing formula for 44% of all wic eligible infants in the country. what additional steps must we take to avoid similar disruption in the lives of these marginalized families in the future? mr. cleveland: thank you. we are the next largest manufacturer at scale to meet the needs of wic consumers in all states. that is a tremendous perhaps ability. -- a tremendous responsibility. to do that effectively we are seeking flexibility, for example, in the size format. while that sounds small it is very significant because it means that the wic consumer does not have to look for one particular size of product. they can find any size to fulfill their benefits with. that has allowed us to continue production and step up to meet the requirements of the consumers. we have worked with the usda to flexibility administer the program. the focus for the wic consumer is the same for others. making sure she has safe access to formula and does not have to compete with non-wic consumers to get it. the more sizes, performance, and manufacturers the program can support, the more likely she is to have her needs met. that is where we have been focused. make as much as we can. then make sure the wic consumer can access that through her benefits. the usda has implemented about every suggestion we have asked them for over the last few weeks and we think we are doing as good of a job as we can. rep. ruiz: i commend the administration for being responsive and the swift action to meet the needs of families. i hope you do the same in years to come. i am concerned low income families are bearing the brunt of this crisis of supply. chair degette: mr. peters, you are now recognized for five minutes. rep. peters: thank you, madam chair. i have questions for mr. calamari. your testimony indicated abbott has invested billions of dollars into things like growing production capacity, creating specialized formulas, enhancing safety and quality. i want to expand the latter point. how much of your resources, either as a percentage or a ballpark figure is going to ensuring the safety of infant formula products? mr. calamari: we spend tens of millions of dollars on quality and maintenance and, in specific to sturgis, that was the foremost investment as well. rep. peters: do you think given what you know now that you should be spending more, devoting more to ensure the safety of your product on the market? mr. calamari: representative, i think we are absolutely committed to investing and it doing what it will take to make sure that we consistently make product to the standards that we all want and that this never happens again. so, we will invest and make sure the resources are available. rep. peters: since 2009 the fda conducted approximately 20 inspections of the abbott sturgis facility. even prior to the recent investigation in january, the two inspections before that also found objectionable conditions or practices. the 2021 inspection in september found abbott has not maintained its building in clean and sanitary conditions. fda inspectors observed standing water and saw personnel working directly with infant formula not washing their hands. i have to say, it has been a while since i had infants in my household. but, we never gave a second thought to the cleanliness of baby formula. i do not imagine most people have a second thought about the rebuy ability -- reliability of that product. but the fda found in 2019 and 2021 inspections, can you specify the actions abbott took following each of those inspections? mr. calamari: in each of those instances we took immediate action to address the observation. some of the key areas included the installation of new flooring , the identification of new processes for how to manage traffic in the plant and also very specific training on individuals about the safety protocols they need to do so this does not happen again. rep. peters: it is really unfortunate that over the years this has contributed to the burden of families trying to feed their children. this is falling heavily on the underserved. 4000 families get wic in my district. i am happy we had this hearing. i hope that things will change. but it is really unfortunate that it has contributed to this burden. i yelled back. chair degette: the chair recognizes ms. schreier for five minutes. rep. schrier: thank you, madam chair. i will tee off what mr. peters was just talking about. i want to thank our panel of witnesses today for being with us and feeding america's infants. i want to make sure we get some questions answered and hopefully reassure parents who have rightfully been very concerned by the shortage and by the safety issues. as some of my colleagues have already mentioned, the baby formula industry in our country is really unique in that 90% of the product is made here in the u.s.. the vast majority is made by your three companies. so, it should be no surprise that when something goes wrong like what happened in sturgis, it does really rock the whole industry. the facility in sturgis is responsible for 40% of abbott's formula on the market. it makes up about 20% of the total formula on the market in the u.s.. that is really significant, especially when this year's similac has the contract with wic. there are two main questions on parents minds now. the first is knowing this statistics, how could you have not anticipated that shutting down the sturgis facility would affect the market and the ability to find formula, especially when people were stocking up because of the pandemic? why didn't you do anything at that point to mitigate the shortages? as i said in the first panel, for babies under 46 months, this is in their nutrition. this and breast-feeding. that's it. there's no other option. that is especially the case if you have babies relying on specialty formulas. mr. calamari, can you tell me when you started importing formula from ireland? to most of us, it seemed like it just happened in the last week. mr. calamari: thank you for the questions. we started increasing our imports from ireland. we did it in january. in february we really started increasing it in the months to follow. that was one of the series of actions we took. we also took immediate action after the recall to convert our adult liquid manufacturing lines to make similac. we started taking action on addressing in the 43 observations what needed to be done at sturgis. we also increased production at our ohio, virginia, and arizona plants. so, while we were working on sturgis we took a series of actions to make sure we were getting more product to the market place. rep. schrier:. thank you. while you are mentioning sturgis, that is the second question on parents minds and pediatricians. it is about trust. why should we trust that once the factory has reopened, those contamination problems will be corrected? there was a problem in 2019 that evidently did not get fixed. there was no inspection in 20 20. in 2021 in the inspection coincidentally happened when a baby got sick. we just heard from the fda conditioner a pretty damming report. we read the whistleblower report about the roof and the floor for sure, and i'm sure you have replaced those. also the lack of handwashing, unsanitary conditions, their shoes, falsifying records, testing empty cans instead of full cans so you could be assured it would have a negative or normal test results. it seems as if there is a cultural problem at the sturgis facility. i hope it's not other ones. this raises questions in my mind. you can put all these requirements on, but if we have a culture of management at these facilities that are falsifying results, why should we trust that? what is happening there? is management being fired? what oversight will you have? mr. calamari: representative, there are two key elements to what you are referring to. one is specific to, we trust in getting sturgis back to producing at the level we all want. we are very much aligned with the fda on the standards and process steps and what needs to be done in the facility and we are taking action on that right now. rep. schrier:. you are. i want to know, the people for the past several years who has been covering up, skirting the rules, misreporting how much formula is in a can, because, there were inconsistencies with weight, this lackadaisical disregard for standards. i understand you get it. i understand your standards. what about them? mr. calamari: respectfully, though whistleblower allegations we do not know to be true. that is an open investigation that was ongoing. i can tell you i was at sturgis last week. the employees i saw are committed to the highest quality. they are committed to learn going forward to be even better. i really want to reemphasize, because that is so critical. the whistleblower allegations have not been proven true. it is an ongoing investigation that is very much being done independently. rep. schrier: i yelled back. -- yield back. >> mr. calamari, i represent a diverse district, one of the most underserved cities across massachusetts. lawrence is a majority minority city. on a per capita basis the city suffered greater numbers of covid infections than any other city or town in massachusetts. this has already stretched the city slip -- city's limited resources and impacted hard-working families there. it is almost unthinkable that the same families that sever the the most through the -- suffered the most through the pandemic are again impacted the most by the baby formula shortage. abbott's similac formula is the exclusive rent for wic. abbott's recall has fallen hardest on states like massachusetts that have contracted with abbott. from may 17 i along with my colleagues from the massachusetts delegation sent you a letter. we have not received a response. i want to follow-up up on the questions now. i was pleased to see that abbott entered into an agreement with the fda to fully correct all of the observations from the inspection and develop plans to reduce and control the risk of bacterial contamination of its products. it also should have never gotten to this point. if you had proper safety protocols in place reinforced with a culture of servicing problems, as my colleagues congress women rice and schreier have pointed out, abbott has publicly stated that the company could resurface -- re-service the sturgis plans in two weeks. installing easily cleanable sanitary floors, confirming process consistency by validating the dry out test method and verifying the dry out procedures. it seems like these are things that to that should have been in place before the recall was necessary. why is abbott only taking these steps now? why can we be certain that there are not other systemic problems the sturgis plant is leaving unaddressed? mr. calamari: sturgis is a facility that has been inspected annually for a decade. it had many years of no observations. it is a plant that has been feeding families for decades. in 2019 and 2021 we did find and identify areas where we needed to improve. we took immediate action. specific to 2022, we are prepared and working around the clock, all hands on deck, to address the issues raised so we can get the facility up the first week of june is our goal. rep. trahan: previous observations by the fda reflected a lax culture when it comes to maintaining a sanitary environment. you mentioned employees are encouraged to flag safety lapses. prior to the whistleblower, how many times that employees flag safety concerns? mr. calamari: i will get back to you with numbers. rep. trahan: additional training or controls. what are you putting in place to make sure this is not an issue when you reopen and according to your testimony, more than double your production? mr. calamari: we will investigate all reports and make sure we have a zero-tolerance tolerance policy for retaliation or misconduct. we have our ethics and compliance office and our hotlines there and additional resources to make sure that employees are heard and there is an avenue to speak up and hear your voice and have your voice raised if you see something. rep. trahan: will the employees that speak up and be rewarded? i think in your culture you need to show folks you are so committed to servicing problems that you will reward employees who bring those problems to your attention so you can get working on fixing them. finally, mr. calamari, what is abbott planning to do with the infant formula held but not recalled at the sturgis plant since february 20 17? are you planning to release the products? if so, how is the company ensuring the safety and quality of the products? mr. calamari: i think you are referring to the product on hold. that product will remain on hold consistent with the consent decree. we made an amendment to the consent decree to release elder care products in alignment with the fda. rep. trahan: thank you. chair degette: the chair will now go to members who are not members of the subcommittee. with that, i first recognize representative dingell for five minutes. rep. dingell: thank you. you know, i have to be really clear about why we are here today. because, abbott nutrition has consistently failed for years to implement basic safety procedures at sturgis, michigan. it hurts me to say that because i am a michigan girl. in 2010 abbott was forced to recall baby formula produced at the facility due to contamination with larva i. e. in 2019, 2021, and 2022 abbott failed to keep its formula free from contamination and the fda recovered bacteria from at least one spot with a contact surface earlier this year at the sturgis facility in addition to the whistleblower complaint which alleges a culture of -- i am worried about all of these babies across the country. the whistleblower report says " abbott has failed to implement adequate internal controls with respect to the sturgis site." mr. calamari, has there been any accountability at abbott for these egregious safety failures? why has the company continuously neglected basic safety procedures at the facility? mr. calamari: representative, thank you for the questions. i want to reiterate our commitment to families. we take our responsibilities very safe -- very seriously. the sturgis plant has a regular inspection calendar. over the last 10 nutritional was acquired by reckitt in 2017. i want to thank the employees of the facility for the hard work during the crisis to get formula back on the shelves mr. calamari, a couple things. some of this has been covered. for work orders and other things , they come into the electronic age. >> we work with fta on the process on how to appropriately document information and on that collaboration. >> that is not the answer, you use paper records if you won't say yes or no. >> we have a combination of electronic capabilities. >> does avid havoc -- have companywide accountability? >> sturgis is connected and they would be part of that. >> you obviously have evidence of that since you are undergrowth. i am a private-sector guy, but this is a serious issue. does avid have an employee -- one of the potential issues is the people they are do not feel like they have the ability to be part of a team that works toward a common goal of having a safe, healthy in compliance -- do they have that at their company or facilities? mr. calamari: representative, i was there last week and i saw the employees there. they may products for their own family. >> a lot of places meet on a daily basis, do they have an electronic way to communicate their concerns considered by management? is there a structure in place? mr. calamari: we have electronic means. we have anonymous one 800 numbers. we have mechanisms in place to speak up and do so anonymously. >> i am a big private sector guy, and i hate the situation we are in. it doesn't feel like that facility culture, it's a long-standing large cultural problem that you see in some facilities with multi generational people both in and out of management, and it seems to me the company needs to be better with oversight. mr. cleveland, we have spoken recently, a lot of the questions i might have asked might have been answered, but i want to give you the last minute to say is there anything you have not been able to mention that would help get baby formula back on the shelves today? mr. cleveland: the number one thing we need is access, consistent access to input materials so we can make as much as possible and help put this behind us. >> i know you are doing other things including getting formula from overseas manufacturing facilities and i appreciate that. i yield back. >> thank you for being here. this is a serious problem i know you are aware of. i am blessed with grandchildren. i had a mother in one of my cities and she wrote to me formula is no longer in stock. look, we need an operation warp speed for formula right now. we need to get it on the shelves as quickly as we can. this is something that was evolving every time. what do you think was the root cause? we need to know because we don't want this to ever happen again. this is one of the worst things we have happened in a long time. mr. calamari: it's a fair point. we think about the backdrop of covid supply and demand, some of the fundamental relationships got challenge and a sustained fashion. on the supply side, we saw ingredients becoming increasingly challenged. we also saw a demand increase, not because they were more births, but changes. we are going to need to look back and see how we can be in a situation for capacity and redundancy. >> staff because ingredients were coming from other countries? mr. calamari: we have global supply chains, ingredients coming from global sources and that's the nature of our supply chain. >> so that would be manufactured in america. i'm trying to understand. mr. calamari: we have five manufacturing facilities in the united dates, i think a key element would be how to we make sure we can ensure supplies are secured. >> what do you think led to this with the plant in michigan? obviously that amplified it, made it worse. but it was already a problem. what can we do to make sure this does not happen again? >> thank you for the question. there have been challenges throughout the pandemic and global supply chain issues were related to that. transportation and labor issues. it has been exasperated by the absence of a major manufacturer from a marketplace for us. >> same question. mr. cleveland: i agree with the clip -- previous comments. in many ways, the example i would use, when something like this happens -- i think the major lesson to learn is how to be more flexible in response to something like this. >> thank you for your responses. it's important we never let this happen again. we need operation warp speed right now. we needed on the shelves as soon as possible. it meets quality standards. we need it now. thank you and i yield back. >> we have come towards the end of their hearing. i would like to recognize the ranking member for final comments or questions you might ask. >> i'm going to make some comments. this is been a good hearing. thank you for having this hearing. it's not been an easy hearing for a lot of witnesses nor should it have been. we learned some things. one, notwithstanding comments to the contrary, i'm convinced abbott needs a change of culture, something is not right and there have been problems for a number of years. that is something they will have to decide. the fda needs to help us help them and is not all about money, it's about using the authority they already have and try to figure out how to be more nimble. figure out how they can acquire information on supply chains without having to use subpoenas or have some new division of the agency created. for us, whether it's food audits or medicines, as the appropriate committee, we need to examine how we remove the inspection process that the fda does. for example, surprise inspections are a good thing. this is not the first hearing i've been involved in were folks were more concerned about getting subpoenas or making sure they notified the plant, and i know it is more polite than to just show up, but this is not about being polite. this is about making sure what we are inspecting is being inspected and not dressed up for a special holiday or inspection. it's about making sure things are safe and done right. they have to make sure they understand they have do not have to send it a single employee with a cell phone and a camera would have picked up the sturgis client, a recurring problem with standing water in the facility. if you saw standing water on a more regular basis it would have been -- we could figure out what other hearings we need to have. ideal back. >> i will say in closing, we have heard from constituents that do not have the formula they need because of this situation, and desperation to figure out how we can get formula to constituents as quickly as possible. i agree with my colleague money does not always help in this situation, but in my years of variance overseeing the fda, it would help us if we had more inspectors and people who would take more of these whistleblower complaints in sensitive areas like this and process them more quickly so we don't end up with a catastrophe like this. we also need to look at the fda authority to see if they need them. with respect to the company's here today, i have comments. mr. calamari, i believe this was an obvious shock, and i believe there is a commitment to fixing it. as mr. griffith just said, this plans has had issues for quite some years, not just the last year, they had issues going back to 2010. when i asked about new protocols to be able to identify problems like this and address them immediately without waiting for fda interference, i frankly found your answers to be vague. you talked about you are putting in new flooring. what we would ask is if abbott develops new procedures to not just hope employees change the culture, but how you will embed that. so we can ensure our constituents we will not have a nice like this again. i have one last question which i will ask you mr. cleveland. we asked some of the witnesses these questions but we really never got much of an answer, is my constituents, let's say my daughter called me up and said i need to get some formula for my baby and store shelves are bare, what can we tell them between now and the emergency measures we wouldn't waste. we should they call? where could they go to try and get this limited product? >> the practical suggestion? mr. calamari: it's unfortunate you have to ask that question. let me do my best to answer it. work with your network of family and friends, look for the product. i have seen mothers, fathers and cousins doing this. you can call our consumer response center. those folks are doing a phenomenal job of fielding waves of calls, but we will help you if you call. that's another resource. the physician's office is another. sometimes they have the samples that are required and can transition between finding product on the shelf. i would be sure to look online and in person at the store and be open to other formats. many mothers have a particular type of format they like. you may need to be more flexible in the format you use, but all infant formula is safe, whether it's a liquid or powder, i would say shop widely. i think those are the best approaches you can take while we work to fill the shelves. >> i know all companies are committed to doing that. thank you to our witnesses for participating. we discussed this during the hearing. members have 10 business days to submit additional questions to the record to be answered by the witnesses who appeared before the subcommittee. i would ask all of the gentlemen to do that. in addition, we would like to insert oversight, and without objection, so ordered. with that, the subcommittee is adjourned. >> we take your life to the white house where president biden is signing an executive order. during this life and progress on c-span. >> when that occurs, it too often is not met with accountability. denying equal justice, not just to individuals, but the whole community, and therefore to our nation as a whole. trust between law enforcement and the community they serve is critical to ensuring public safety.

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