This is what democracy it look spirit cspan powered by cable. Its now a top official from the food and Drug Administration or text if with baby formula shortage. Susan main director of the fda center for food safety and applied Nutrition Program also fielded questions on reporting bacteria in the production process and rural distribution formula. On the House Oversight subcommittee this is about an hour and 20 minutes. But the subcommand healthcare and Financial Services will come to order. Welcome everyone. Without objection the chair may declare recess at any time. I recognize myself for the purposes of making opening statement. Thank you again for being here, i appreciate her at six weeks ago the subcommittee held its first Oversight Committee on last years infant formula crisis. During that hearing we heard from former Deputy Commissioner in charge of food, policy and response. Testimony highlighted many internal failures within the fda that led to the crisis in clinic fda port efforts to carry out one of the most Critical Missions which is food safety. His testimony raise questions of why key facts about the crisis were omitted when nick testified before the energy and commerce Committee Last february. And in the socalled independent solomon report. Todays hearing will continue the log and overdue oversight of the food and Drug Administrations response to the infant baby formula crisis. We hope to get answers on why the fda has not been fully forthcoming with congress when really the for todays hearing will examine why it took more than four months for inspectors to arrive at the facility plant in michigan after baby started getting sick. We will determine what took took so long for the bite administration to take act secure the baby formula supply while recalled lofted shelves bear. Why was the fda and prepared for the crisis . Why did they only inspect three of 23 infant formula manufacturing facilities in 2020 . Three of 23. Why they failed to investigate whistleblower warnings quest worked in the fda followed regular two protocol cost . Did they respond quickly enough . Was the fda independent review truly independent or was it a cover up . Today i will get answers to these questions to better understand exactly what happened to accent happen again. American families must be comp at the fda has the ability to prevent a crisis like this from ever happening again. In our previous earrings happen but could have been better from fda officials. How it lays out the fda ignored abbott employee 38 page disclosure detailing concerns of the sturgis plant. The fda telework policies lack of oversight with unprepared accuracy supply Chain Shortages after the sturgis facility section shut down. The fda had failed to prioritize food safety. The fda has not taken the action needed to prevent a similar crisis from happening again. The American People paid the fda 6. 7 billion last year. 6. 7. Next years budget the fda once over 10 more totaling sevenpoint to billion. I think the American People have a right to know if you only took a look at three out of 23 and you were paid fully, now we have a crisis, we dont really have answers to the crisis but yet you want more money esther mark lesson, we all want everyone to be safe. We ought to make sure we are safe but i think we all also want to make sure our money is going to do to good work. I think the American People deserve to know if we are going to have these agencies and were going to spend a lot of money on these agencies comment these agencies need to make sure theyre doing their job. As just opposed to throwing money at the problem. Fda field inspectors shouldve been doing the jobs but they werent there were not serious consequences. When you get to hear what the consequence for the fda is other than give me more money. They did not do their job. They sat at home for this talk at their paychecks. They want more money which may help, but what is going to change . No sign of the current fda leadership to be held responsible. In business the stockholders are held responsible. People get fired. They lose money, they lose profits. There is a consequence of the action. I have yet to hear who is responsible at the fda and what is the consequence for their failure . I think we deserve that especially for over 6 million worth of money. Here we will discuss what fails when the fda led to the crisis we will discuss ways the fda can improve its internal controls to get ahead of potential disruptions and prevent future supply chains. Will discuss why the fda admitted facts from the public. We owe it to parents, caregivers and infants to get to the bottom of what really happened. To fix it. We cannot fix a problem that we first cannot admit exists. As a set in the last of the families of these babies that died from contaminated formula deserve answers on how this tragedy was allowed to occur in the first place. And what we can do to prevent it from happening again. So thank you for being here today. Congratulations on upcoming retirement look for it your testimony now yields a mite Ranking Member ms. Porter for her opening statement. Quick stinky very much better charwoman. Today it read in the part of her subcommittee hearing series on the 2022 infant firmament shortage. So far the chairwoman and i agree on something really important. Infant formula shortage could repeat itself. 43 of formula products were out of stock continued which killed nine babies eight hundreds of others felt ill. Prompted a recalled shopper from the supply chain. That disruption of course interrupted our economy. But were critically threaten the health, nutrition and lives of our kids and confidence in government. Today we are sitting on a bipartisan basis that it could happen again. We have a duty to do something meaningful about it. This year is called responsibility for the infant formula shortage. And as i said last time there is a lot of blame to go around. With todays witness election republicans want to blame the fda. I will level it with you, some at that blame is wellplaced. To subsequent input form it recalls in 2023 already were still seeing the fda can make further improvements on internal processes, enter being an issue sooner and follow through with more inspections to prevent further contamination. Other lawmakers today will blame formula manufactured for their negligence and failure to produce safe products. And that is true to priscilla others will blame washington for allowing just three manufacturers do have control over 90 of the farm market. Im for failing to invest the resources and authority in the fda that it needs to produce the results we demand. I think those folks are correct to break the thing about this issue though it does not come down to the fault of one person for one agency, one company or one political party. We cannot fire or attack so what expect formula contamination shortages to just go away. That is why today i propose we go be on the title of this hearing but we need to move beyond just assigning responsibility toward delivering solutions that can prevent a shortage from happening again. To think the chair with her work with me on that. We need to use these hearings to identify what art were the proposals were the innovations made to transform them into legislation. We do not do that were failing to solve the future problems would risk blaming and shaming rather than preventing and problemsolving. If if we Work Together we can address the deficiencies and inefficiencies that risk the supply of safe healthy infant formula. Likely be up fda expert us who can help us with that. Look, doctor mayne can handle what we are going to throw at her. We should ask hard questions. We should push her on ares we the fda can and should do better. But we should also use her knowledge to figure out what congress should be doing better. Right now the fda is reorganizing its human Goods Program to reduce fragmentation improve coordination. That is not going to solve all the fundamental issues. Even with the best structure, leadership and resources the fda is only as wellequipped and as accountable as Congress Makes it be. So, what we called the fda and others responsible what can congress be doing to help . First we have to provide the fda of the resources to its inspection and food safety capacity. You cannot expect an agency to get better when youre taking away the funding for the personnel and technology needed to make it happen. Thats within that 22 cut to the fda the republicans voted for would make this problem worse. Lets not go down that path of expect the fda to do better when to set it up for success and hold it accountable to deliver on a better outcome. Whether we reach bipartisan consensus on proper funding or not, there are some nocost reforms we should be able to agree on. We need better processes for reporting and tracking contaminations. For that thats making a nationally known viable disease, or make it your all contaminations and critical food factories are promptly improperly reported. If we use doctor mayne as a resource we can find solutions we could all agree on to save kids and stop shortages. Lets come out of this year with next steps just complains about missteps. I yield back. X thank you ms. Porter. Now im pleased to introduce a witness who is here to discuss the fdas response to that 2022 infant baby formula shortage. Doctor susan is the director of the center for food safety and applied nutrition at the food and Drug Administration. She has been in this role since january of 2015. Doctor mayne has received a ba in chemistry from the university of colorado. Jess also earned a phd in Nutritional Sciences with the minor some biochemistry and toxicology from cornell university. Pursuant to rule 98 witness will please stand and raise her right hand. Do you solemnly swear or affirm the testament youre about to give is a truth, the whole truth and nothing but the truth so help you god . Thank you for that the records show the witness answered in the affirmative. And now we appreciate being here today. I really do look forward to your testimony. Let me remind the witness we have read or written statement that will appear in full and the hearing record. Please limit your oral statements to five minutes. And as a reminder please press the button on the microphone in front of you so it is on the members here but when the begin to speak the light from the looks are great after four minutes about will be yellow in the red light comes on your five minutes has expired would ask that you please wrap up for this i recognize your opening statement. Chairwoman mcclain, joe cromer, Ranking Members porter, rested members of the subcommittee thank you provide me testify the safety and supply of infant formula in the United States for as a parent myself, i know nothing is more important than the health and safety of our children. Lesters infant formula repose shortage put a strain on parents and caregivers across the u. S. Which of the egregious conditions of Abbott Sturgis facility we knew a rico could stress an already unstable marketplace but we had to put our childrens safety first. Fda takes the situation extremely seriously and has applied many Lessons Learned resulting in greater confidence in infant formula safety. When the most important lessons we learned was agency must do all that it can to ensure no infant formula facility ever has the level of in sanitary conditions are present at Abbott Sturgis in early 2022. I made progress in the post extent of our authorities to address Lessons Learned preventing another shortage in the future will require a continual whole of government approach, increase industry accountability and cooperation and help from Congress Rate today i like to talk about the future of infant formula safety and our vision for modern regulatory approach. First, the ultimate responsibility to produce a product is on infant formula manufacturers. Many industry to comply with our requirements and to adopt enhanced food Safety Measures to deliver the safest possible infant formula. Two months ago issued a call to action to industry to take specific steps improve food Safety Practices for the protection of infants. Second, we were diligent to increase the supply formula on u. S. Market. The insect great performance near 90 which is harder than prerecall levels. Overall production exceeds sales week after week. Market consolidation is a serious concern and contributed significantly to shortages for their currently only three major domestic producers of formula. This means any disruption a recall, International Conflict or Natural Disaster could impact formula supplier temporary exercise of Enforcement Discretion enables a product to enter the u. S. Market, doubling the number producing infant formula for the u. S. Almost all of the manufacturers participated under the Enforcement Discretion policy are taken the necessary steps to stay in the u. S. Market. Federal Agency Partners also have an Important Role in helping to address market consolidation. We will continue to work with them to encourage a stronger more diversified more resilient u. S. Infant formula market. Third, the industry should be able to address product contamination near or in realtime. Our inspections are currently a snapshot in time. More realtime oversight can transform infant formula regulation by ensuring firms promptly investigate product contamination and destroy adulterated product before it reaches consumers. The to do this we need modern authorities including explicit authority to require industry to notify us when formula test positive. Even if the product is not left the facility and the ability to obtain records remotely from all three manufacturers. Fourth, we continue to advance the science around a very common package in the environment but one about which you have limited information. Infection chevy at nationally notify about disease to local, state Public Health partners can reliably collect information on all cases. We can rapidly link cases to potential sources of contamination. Fifth, we are intent on delivering empowered unified Foods Program worldclass field force that will deliver modern integrated oversight. As part of the spill creating office of critical foods as required by the act. Routes are actively hiring for specialized infant formula inspection staff that will execute a modern preventive approach to infant formula inspections. Lastly come the early days of covid 2020 and well before the abbott recall infant ford shortage, we recognize the critical need to better resource our infant Formula Program. We are grateful for the resources we have received but our human Foods Program are still in dire need of additional investment in update to meet current as well as future challenges. Are you familiar with the fda internal Agency Review led by doctor salomon . Yes, i am. Weve interviewed by doctor salomon during course of the review. No i was interviewed by the same group of folks who were interviewing all of the people of who have participated in the interviews that information was consolidated put together for dr. Solomon. Why didnt you think you were interviewed . Sorry . Why didnt you think . He didnt for individuals there were large number of people done across all of the interviewee. Anyone in the hhs author the report . Did anyone sorry did anyone apart from doctor solomon did anyone else at hss offer the report . No not to my knowledge. What was Principle Committee in the report . I believe she was one of the individual who is called for the report so that we would look internally at our process and see what changes could be made expeditiously in the spirit of Continuous Improvement. Okay was she involved in the report . Other than asking that the report be executed not to my knowledge. We received witness testimony that implies that she was involved ill give you another chance to answer. Did he report in any way . She asked that it was conducted the data was compiled produced in the report she asked that the report be conducted along with commissioner. Comptroller general gene stated in april 26th, 2023 House Oversight hearing that the fda is not, quote, not doing enough to improve to Food Security and food castes. Food safety has been on the gao high risk in 2007. Doctor mean do you think fda is doing enough tone sure food safety . We can always do more to ensure food safety and ill come here today with things we can do to ensure formula manufacturing having said that weve worked closely with u. S. Department of agriculture as we assure the food safety for the u. S. Okay did the foundation for the fda conduct an operational evaluation of fda food human Foods Program . The Reagan Foundation did not conduct evaluation but they convene a group of independent experts that conducted that evaluation so it is not done by the foundation but independent experts. This report describes fda Food Division in a culture of constant it describes their Food Division in a culture of constant turmoil. Do you agree with the Reagan Foundation assessment . My indication of their assessment was that the reporting and Decision Making needed to be streamlined which is something i agree with. That organizational changes could make a more efficient and Effective Program which i also agree with so those were primary recommendations coming out of Reagan Foundation. Okay. Covid19 was used in excuse for fda not receiving a whistleblower complaint about the avid plan. Commissioner testified before congress that the whistleblower report was not transmitted to key fda food safety official like yourself because the covid19 because of a covid19 mail issue do you believe the report was actually lost in the mail . I i cant speak as to what happened to the report itself being lost in the mail but what i can speak to is the if report was received at fda it was received by our field inspection of force and they worked on the report they acknowledge that they received the reports. They then went ahead and reviewed the report. There were some very serious allegations in the report so they sought information from the office of criminal investigations and so they did acts upon it. It is correct that Senior Leadership was not made aware of that so it was not that fda didnt act upon it. But that simply Senior Leadership was not aware of that. Acted on it but didnt tell the leadership. That is correct it was not eveninglated there was no process within fda to evening late this particular whistleblower complaint. Fda received a large number of whistleblower complaints so it was a failure of escalation. I do wish i had been made aware of this particular whistleblower complaint but just to reiterate complaint was angted upon but leadership was notes aware of that. Did it surprise you . Which that the complaint itself or yeah. The complaint was very lengthy and very had a lot of egregious claims in there statements in there allegations in there. There were very troubling things in there what surprised me was language about data falsification and trying to hide information from federal regulators. Given the nature of some of those allegations that is why the inspector engaged office of criminal investigations regard to that whistleblower complaint. Thank you. Thank you now recognize rank member porter. In our first infant formula hearing i asked the majorities witness a simple question. And the cause the answer caused a little bit of bipartisan shock. I thought had shoot upward so i asked the same question again so im going to start by asking doctor main. Lets say a major formula manufacture finds bacteria in its supply today. Does the law require it to tell the fda . The answer is no. So we all heard that correctly. The law puts no one at the fda in charge or on notice if a major formula manufacture find bacteria in the supply. So if we want to solve formula safety issues, someone needs to be monitoring real time bacterial contaminations. Doctor main who can change thes law . To put someone in charge of this . Is it up to the fda to change this rule, manufactures or congress . We need congresss help to modify that and we have we have fought that from congress. So i think lawmakers can and must point some fingers at the fda and at manufacturers. But we need to also be willing to point finger back at ourselves. The truth is, we didnt do enough in last years on yeah we gave fda new authorities and one was requiring manufacturers to notify the fda of any interruption that would likely lead to a meaningful disruption in infant formula supply. Dr. Mien im wondering if you saw the same problem yods. Lets think like parents here, like moms if theres deadly bacteria in a formula that your infant could eats would you want the fda to know about it only when it might cause a supply shortage or would you want the fda to know any time your infant could get contaminated formula . Just to be clear we really need is in the production in the manufacturing facility before it enter leaves that facility that is what were seeking is industry would notify us before it enter would leave the facility so we can make sure that the proper amount of formula is destroyed to protect infants. Yep so you would want to know if there was a bacterial contamination whether it would cause a supply chain shortage or not. The fda should know. Correct and by knowing in real time that is a good way to prevent a supply change shortage exactly. So we keep kids safe and we didnt do last year and there was a democratic and full Congress Last year it is on us i think to lead the way here. Congress did not provide the authority for a full reporting process and so now we have more work to do. In thes meantime this has real world consequences. Weve had two major infant formula recalls so far in 2023 from gerber would either of these have been reportable to the fda under the new provision of the law. No. That was no. Sorry. No so im leading legislation that would establish a process for the fda to be notified when manufacturers critical Food Products test positive for food born pathogens doctor main it is no secret that the fda has had some struggles in responding to inpangt decams but fda has identified this legal change as something that it needs in order to do better and im ready to Push Congress to deliver for you and expect you to deliver back to us. So im ready to whip democrat and republicans to join together to act but i want to think through the oversight piece of this. Can you tell us a little bit about how required reporting of contamination would better equip the fda to address contamination issues before they impact you mention identifying right amount of formula to be destroyed are there other feature to cleaning and property call. By knowing in real time that theres been product contamination in thes manufacturing facility our experts food Safety Experts are compliance experts can work with the manufacturers to determine to essentially bracket or scope the amount of what needs to be destroyed. And that essentially means any product that was produced since the last sanitation break and before the next sanitation break. And thats where we have seen issues with recent recalls where companies had destroyed product that they identified to be contaminated. But we didnt determine that they destroyed a sufficient amount between those sanitation breaks. So working in real time with the industry to make sure that the proper amount of product is destroyed to critical to enhance food safety. It also allows industry to do a root cause analysis working with fda and our experts to identify why did it get contaminated closer in time when the actual contamination event occurred. Thank you very much. I know that members on this Sub Committee care a lot about this issue and i know that Sub Committee chairwoman maclaine does too im excited to move this legislation forwards on a bipartisan basis so i want to invite all of our colleagues on the Sub Committee and on Oversight Committee to join in this legislation. We need to give the fda the information it needs in real time to be able to both prevent supply shortages but more importantly to keep everybody safe. Together we really can help solve this problem. I yield back. Thank you ms. Port now recognize myself it is amazing to me and saddens me a little bit that we actually is have to legislate this, but if thats what it takes to keep people safe, i mean, its a shame that we have to legislate if theres a problem, fix it. With that said, i think we also know that theres enough blame to go around. This isnt a one specific, you know, i have the lucky star here and ill fix everything. But i have you in front of me today so i want to focus my questions around the fda. Im im concerned by lack of inspections at the abbot facility im not saying you know, youre the only one to blame. But between the fall of 2019 and 2021, there was just not a lot of inspections going on. The fda may 2021 resiliency world map claim agency prioritized Mission Critical inspections during the pandemic. In according to the fda, the criteria for michigan Mission Critical inspections is a product is used to treat a serious disease or medical condition an theres no substitute. Is that partially correct . S that my understanding. So a product with no substitute to me that sounds like baby formula. You know other than mothers breast milk but some mothers cant breastfeed for whatever reason. Inspections are also Mission Critical when there is an evidence of serious adverse events or outbreaks of a food born illness. And again that sounds to me like the abbott plan. At the time in 2020 there was no evidence of outbreaks or illnesses at that time when the routine surveillance inspections were not in progress. So can you just repeat that one more time there was no evidence in 21 . There was in 2020 youre talking about in 2020 there was inspection in 2021. In the fall of 2021 four months after, i believe. The first complaint came in september of 2021 when we were actually doing the inspection. From the same time at the same time. I think from what i show it was four it was discovered in february. But there were no there were no inspections done, in fact, despite this 20 of the 23 infants formula packing and distribution plants in the u. S. Were not inspected for two years if you go back to critical and toipght get that i think we need to change what is critical why is infant formula not considered Mission Critical to the fda . So first of all, i dont oversee the inspectional branch of the agency. Theres world map did come of the Inspection Branch i can share but there may be things i need to take back essentially nchtion in march of 2020 routine surveillance inspections were not executed during the early phases of koafdz. That was they were reinstituted in july of 2020. Let me stop you right there. This is part of the concern is inspectors not doing inspections because of covid. Were they getting paid during that period of time . That was routine surveillance Mission Critical inspections were conduct throughout the pandemic so we bsh i appreciate that can you answer my question were they paid . Yes inspectors continued to be paid they were doing Mission Critical inspections. Baby formula is not Mission Critical. Manufacturers were inspected in 2020 my records indicate there were five infant formula inspections during 2020. Our congressional under fisma food monitor safety act supposed to inspect once every three years our practice is annually. But you didnt inspect annually and im going to ask my question again is baby formula critical deemed Mission Critical . Yes or no. Back to the office of Regulatory Affairs because i do not know cry tee ya for an inspection. Okay. Okay i just want to make sure everything i have everything because i understand it took until january 31st of 2022 for fda to inspect the facility is that cent . No we inspected in september of 2021 at that inspection we noted several violations for abbott nutrition. And we issued a 483 noaght those violations that came back to us with a 28 page report saying that they would investigate and correct those actions committing to make those changes when we went back in january of 2022 they had not made those corrections, in fact, rather than correcting the sufficients in 2021 situation deteriorated that led us to the situation leading to the recall. Woke that im out of time and i want to be respectful so chair now recognizes one moment thank you madam chair. Im focused on the future like my colleagues here and preventing this from ever happening again. Now our colleagues have asked to prengt another formula shortage i appreciate that. However, at the height of the formula shortage, crisis 192 House Republicans voted against investing 28 Million Dollars in funding to help the fda conduct oversight and hold companies accountable. And it may 2022 republicans chose not to join democrats on this committee and our investigation into abbotts role in infant formula shortage. Ing now, with the House Republicans default on america act, they are proposing massive cuts to nondefense Discretionary Spending which to a layperson means all of that other stuff that takes care of americans. And doctor main, how would a budget cut of approximately 22. Affect the fdas ability to employ inspectors and conduct inspections of formula manufacturing facilities . Broadly across the fda i can say it would be devastating that would translate into about a 790 Million Dollar cut in our Budget Authority. And broadly across the agency that means that that could result in a loss of 32 of our domestic inspections in 22 of our Foreign Inspections including in countries like india and china. In terms of a Foods Program where i am our budget is largely based upon Budget Authority 97 of our budget is Budget Authority. We have very few users fees in the human Foods Program so that means that cut could disproportionately affect the human Foods Program it would also impact our ability to administration and innovation and damage have i, it would damage us, what we constantly hear from industry is predictability and we have a premarket Approval Program as well. All of those would be adversely impacted and we would be unable to do what i think American Consumers expect us to do given that they eat foods every single day. Doctor main just to be clear, you said 790 million. Is that correct . That is correct. Thank you. In january 2023 fda commissioner began implementing recommendations of internal and external reviews by announcing theyre restructuring of the human Foods Program and by unifying several offices under a single new Deputy Commissioner. And so im wondering how would the budget cuts affect fdas ability to implement those recommendations from its internal and external reviews to make sure that we have better oversight over infant formula which is what we all want. I think it would be devastating. We wouldnt have the people we wouldnt have necessary oversight a cut of that magnitude and human Foods Program we would be back to a same number of ftes that weve had ats our lowest point in the last 40 years. Just as a point of reference in that i lead in 1978 we had a thousand ftes right now were at 1100. So if we took 22 cut with given most of our budget is in payroll, we would be below the number of employees that we have in 1978. And of course, our mandate expanded dramatically since 1978. Sure. Doctor main, lets talk about the bottom line. Who in fact will get hurt if fda human Foods Program does not get the resources that it needs it is like really clear for people. I think and the American Consumers would be you know, would be impacted adversely by that. All of our surveillance, all of the sampling, all of the things we do the interception through the International Mail facilities those all require resources and people and that would be adversely impacted. But i also think it would adversely impact industry. Tell me about that. Every time industry wants to put new innovation whether it be selfculture meat or whether it be genetically engineered crops to support drought resistance Climate Change challenges into the future. Our reviewers work to help bring these products to market safely and successfully. If there are concerns about food safety, these products will never be successful in the market. So it is imperative that we are there to do that. Regard infant Formula Program even though we run a Notification Program where we knew infant formulas before they come into the u. S. Market. We have been doing that with nine infant formula reviewers, we saw an increase in complexity coming in applications that in the past the cape to believe the review those products appropriately before they come into the market as a sole source of nutrition for our infants. Thank you dr. Main i yield back. Chair now recognizes ms. Lee for five minutes five minutes thank you madam chair. The infant formula shortage has been horrible for all parents but its been even more devastating for low income families who dont have the luxury of switching to more expensive brands or easy access to multiple stores to search for stock formula because they lived in food deserts. My district was hit particularly heart disease. With pittsburgh among top ten areas with worst shortages i can imagine stress and uncertainty those families felt as they did everything they could to find food for their babies. We need to learn from this shortage and do better. The answer is, of course, not the 22. Across the board cuts. As past republican last month a cut that would mean 1. 7 million infants and children lose nutrition assistance through wic and march of this year, the fda issued an Immediate National strategy geared toward increasing resilience in infant formula supply chain. Dr. Main how do the longterm and shortterm plans ensure that low income and rural families get the formula supply they need in the futuresome . So i think for the immediate future we have been build up supply chain as you heard me in stock rates are now at 90 which is better than they were before the recall. Formula manufacturers are producing more than is being purchased week after week after week. So the supply is building up. It has been building up steadily and thats really important. Theres still challenges with distribution right now. And what we keep hearing is that its not equitable across this country that rural areas have harder challenges getting the formula they need and especially people who are served by priests or independent grocers. But what were doing working with National Grocers association that use whatever data they can give us to give to the infant formula manufacturers say this is where the distribution is most challenging. We dont control that distribution. But we can certainly help provide information to make sure that areas food deserts rural areas, areas that are more challenged to getting access to product can access that. For the future, obviously, i think there are things looking at you mention the usda wic program ive known necks of congress are looking at that program to see how can that help support better resilience as you know many of our lowest income and that is a critical source the wic program to provide formula for those infants infano gaining through wic is another critical aspect and i know congress is interested in that and it is another thing we can do. Thank you that was my next question so i will move to another foundation independent evaluation suggest reorganization of the human Foods Program. How will that improve how fda operates ats overseas infant formula safety and production . Infant formula safety is one part of that. But the really big Reagan Foundation is looking at thes overall human Foods Program. And its really taking a variety at how we can do things more effectively weve heard from so many of our employees what would make your jobs easier an insufficiency and resign a modern program to be more effective for the future that is a special case that were really very, very laser focused on how to do that beaters. Better so we have for example made a commitment to have an inspect to increase numbers so these are inspectors only dedicated to infant formula manufacturers. The training, working through our . Ifng experts were committed to doing so much more. Working with industry, making sure they understand all of our standards, how to produce infant formula in a very safe way so there are a number of actions that we have identified in the national strategy. On the steps that we can take, to get to a better place in the future. I think thats a good road map for the future. Thank you. I understand after agency is considering asking congress to give it the authority to require companies to submit positive results for as we were discussing with rank and member porter. How is granting that will prevent another shortage in the future . So we can work manufacturers in real time make sure no contaminated product enters the market and as i noted earlier to make sure that industry is trying to get to the root causes. We need to prevent kadges in the manufacturing facility in the first place. And doing that in real time is a heck of a lot easier than waiting until many months later when we may become aware of positive caption and seeking that authorities were asking industry to do more Environmental Monitoring that means sampling your food facility and finding that bacteria and eradicating giving it out of the facility in the first place. And retaining ice and we have food safety, but we need to get the bacterial in order to utilize new technology for better food safety. Thank you thats my time i el thank you chair now recognizes mr. Grossman. Thank you. And previous congressional testimony before the energy and commerce committee, in may of 22 u. N. Commissioner providing official document entitled timeline of infant formula related activities. Which is here i like ask unanimous consent to enter this document into the record. Thank you. Is this timeline complete according to the agencies activities up to that point . The timeline didnt entail every single activity we did because they were working around clock day in and day out but its just a synopsis of the major activities that agency conducted during months leading up to and following the february 17th recall. Okay. In a document recently provided by hhs to the committee there appears to have been two pages of extra information that have been added to this original timeline. Most of the Additional Information predates may 2022 hearing. Why was this information admitted in the previous congressional testimony . I dont know what the timing of those new informational events were. I havent seen that document so i would assume its a more updated document but i havent seen document so i cant comment. Okay. One piece of information i found is that the fda actually received a complaint about the conditions and the of the abbott facility in february 2021. Yet they didnt take it seriously. Why do you feel this important fact was not shared with the American People at that time . We were not aware that that complaint had been sent into the f das it was forwarded from osha i dont have first hand knowledge of that particular mailbox but my understanding is it was not processed and addressed promptly and in fact i was not aware of that complaint when we testified in may of 2022. Somebody should have told you its also been brought to our attention that fda had opportunity to highlight formula in usda report on american supply chains in august 2021. Why did your office ultimately oppose the inclusion of infant formula in that report . I have no information about that. I know im notes sure what report that was. But what i can say is that we work fda with usda on the supply Chain Task Force. And we have been working with usda throughout the pandemic on supply chain including consideration of various commodities that were at risk and usda and fda were both aware that infant formula was potential commodity at risk that is one of the reasons i came to the appropriate in 2021 seeking Additional Resources for infant formula and we were grateful to receive those in 2022. Remaining facts fda holding from congress and to the American People. During the coveted Team Pandemic fda funded 21 Ford Initiative to assist pandemic supplychain vulnerabilities. Why was this program are other supplychain analytics not utilized to evaluate in stock rates of infant formula at the National Level until it was too late . Its part of art food drug and cosmetic act authorities are food safety and nutrition. We do not have authorities, resources to do supplychain monitoring. We did what would collude with the information he had. We purchase, should all ford budgets without any resources received publicly available data such as the iri data to try to understand what was happening regardless supplychain. That was an initiative we took on out of a concern for what could happen with the infant form of supply chain. Has been reported staff request estate in 2021 for funding from covid19 supplemental funds to further develop 21 a forward data analytical platform to monitor the food supply chain. However then acting commissioner Janet Woodcock cut they simply food supplychain requests opting to fund similar request for increased monitoring of drug supply chains. Why was a food supply monitoring request cut . Yet one for the drug supply chain approved . I cannot confirm anything about that i have no information out about that i did not participate in any of that. Okay, they gave her a quick thank, chernow recognizes ms. Porter. Asked to understand how the infant shortage of format happened i want to take a look and a little more detail about Abbott Sturgis michigan production facility. But so back to 2021 and 2022 when doctor made you left the center for food safety and applied nutrition but according to the fdas timeline of the infant shortage fda conducted initial inspection abbott manufacturing facility in sturgis on september 2021 is that correct . Like that is correct. That inspection revealed multiple unsanitary improperly maintained working conditions, correct . That is correct. Fda further initiate a further inspection of the sturgis michigan plant from january to march 2022, correct . Yes. What did those additional inspections in 2022 early 2022 reveal . We noted deficiencies in the plant. Sanitation, plant conditions in september 2021 bird those were delivered to a company through 483 at regulatory meetings with their leadership are they committed to address our concerns in writing back to us through an investigation of to make those controls. We got there in january 2022 though since had not happened but affect the plants condition had deteriorated. That led us to do our own Environmental Monitoring. Abbott also did Environmental Monitoring of the plant given the conditions we saw. That is only identified five different strengths of corona vector in the manufacturing facility. So all of that information along to the whistleblower complaint and the consumer plate complaints we had received led to the voluntary recall in february 2022. Fda inspection report. The timeline of infant formula related activities to usda. Next in march 2022 fda inspection report which detailed the fda observation of multiple unsanitary conditions that you just described, it says the fda Inspection Team observed how that float did a system of process controls designed to ensure infant formula does not become adulterated unquote. The team also found abbott quote did not ensure all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source. Inspectors found employees work directly with formula failing to wear the necessary protective apparel app its own self investigation failed to conclude whether its operations by health hazard. But is unacceptable and i think you agree based on how you described was on september 2021 and what you saw early 2022. I was unacceptable for company to manufacture more than 40 of the infant formula sold in the United States is a major recipient of government dollars via the wic program to keep its facility in such poor conditions. It puts babies at risk for it as a result of all this failure to follow the rules, failure to respond to regulars despite promises to do so, we wound up with a recall in february 2022. What Lessons Learned from abbotts failure to keep its plants inappropriate condition commitments but failure to follow through on those commitments to do better by 2022, what can we learn from that . From this experience to make sure the next time the fdi fda tells a formant manufacturer to clean up their plant they did not arrive six months leaders invent things of actually got worse . We agree the conditions were egregious. In fact that is all we took the exaggerated step to putting into place a Consent Decree resumption of manufacturing would be overseen by independent expert and work with our investigators and our subject Matter Experts to make sure they could resume safe production but thats in the usual step but given the condition resolve he took it. But we worked on is trying to recalibrate the infant formula manufacturers broadly. That is the call to action were bleached in march of this year. We identified many deficiencies in the abbott inspection. We identified deficiencies and other manufacturers as well by the call to action is for all infant formula manufacturers to do better. We have been engaging with them regularly we have a prevention strategy. Our food Safety Experts are working directly with their food Safety Experts to explain what we expect or say formula production. We are on a path to be in a better food safety situation and not running into the situation we found ourselves in and the abbott plant situation january 2022. And curiel back. Thank you the chart now recognizes for five minutes. Thank you madam chair for the more information we get the more questions that are created. It really seems that theres a pattern of delay, delay, delay here. The chairwoman already asked what took so long to inspect the sturgis plant . Why was there a threemonth delay between the abbott recall in the closure february 17 and the decision to waive fda strict formula labeling importation requirements may 22 despite the National Shortages . There were many questions embedded in their print limited what a time. You mentioned labeling. We put in place Enforcement Discretion policy to allow nutritious formant to come into this country to help make sure parents could find on store shelves during the period of the national shortage. We did have certain labeling requirements they are properly things like safety. For example a baby that has a cows milk allergy need to know of a formula is based on cows milk or soy. There are certain label issues that are critically important for safety like allergen information. Also how to prepare a formula. Some need to be diluted to different amounts that others. Over diluted risks having infants not get enough nutrition but under diluting it will not go through a bottle and they wont get it. I understand why we would have labeling. But why is there a delay from february 17 until 3 months later when the labeling took place customer funds are such a delay in the labeling . Lexi formant recall start on february 17. We then went through a series of steps to try to address shortages regarding infant formula. Given that market concentration in this country that is not an easy step. There were a number of things we did for example received product from across our borders from domestic manufacturers that plants and other countries but we expedited the entry of those coming into the country. We work with infant formula manufacturers that were not at the abbott plant, not the sturgis plant, to increase their production. We did a number of different steps to get that into place. We wanted to bring in Safety Product from abroad we had to put out a guidance document is a few hunting product into this country, this is what we need to see if any of her winning clerk though they meet our nutritional criteria. Make sure those products have been tested for safety the same it be tested. We got the application pursuant those products into this country. In total we issued i think it was 36 different 20 letters 36 different products including specially in metals medical products allowed to come into this country under Enforcement Discretion. We have now doubled the infant formant manufacturers bring practice country that through fda action. We jumped into action lias what leverage we had to address the shortage formula. But there were some way could not address the market concentration. As you heard me try to take steps to address this. More things are needed to prevent this into the future. We are very willing to work with congress and all of government response to make sure we dont have this problem again the future. A week before the formant recall on november 10 fda leadership activate coordinated outbreak response and Evaluation Network core. Tiered knowledge or senior white house officials notified at that point . On Senate White House officials were notified on february 16. Do not know if there notified on february 10. I am aware we did send a communication to the supply Chain Task Force which would include the white house on february 16. Which was the day before the recall. And just to be clear science was evolving. On february 10 we did not have the information place that we had had a run of activate that information was not available. We were doing the inspections, which collected samples for the innovation and the sequences actually came in on february 13. At that point we had more information this implant was contaminated on febrile 13 and without that led to the ask of abbott to voluntarily recall. We notified the white house and others unfair for a 16th to the recall occurring. Looks at the white house was away or white it takes three months with him to step in and help address the shortage of baby formula . I cannot speak to what the white house actions were. But what i can speak to as we were working in all of government way throughout this process. Including with regard to the Enforcement Discretion products move very closely with health and Human Services on operation fly formula to bring those products to the u. S. Market as quickly as possible to help rectify this shortages that appearance in this country were experiencing. Lastly yes or no did you talk to the white house about the possibility of a formula shortage, if so when . I am aware we talk to them through a written memo on february 16. Whether they were previous conversations with the white house i cannot say. I can say that information was shared to the white house before the recall occurred. Thank you and he yelled back madam chair for. They get the chair recognizes for five minutes. Thank you madam chair. In september 20, 2022 fda issued a valuation issues response of the infinite shortage. Fda director for sentient venturing medicine drafted the report. Following these subcommittees march 2023 hearings are just a few weeks ago, on the infant formula shortage some by republican colleagues made some claims about how fda conducted its internal review of the infant formula response. To your knowledge, whites and fda tab key view, to write the internal review and instead selected doctor solomon . Doctor salma was not involved in any way in the infant formula response. Myself and doctor woodcock was the acting commissioner leading up to february 17. All of us were involved in the response. Having us evaluate ourselves is illogical. Got it. She needed some impartial part you could have the fox watching the head has started to speak or text me the fda well probes knew that processes and the procedures of the fda wealth assignment but not to translate all the acronyms, everything we discussed the processes. But he was not involved in infant formula response in any way. One other thing this was an internal response. We are very committed to improving our processes and procedures as expeditiously as we could. There are lifetime of recommendations that came out of that report. We have been working hard every day, every week to move further those recommendations but we have made great progress. In addressing many recommendations for the same time theres an external review of our program was convened by the Reagan Foundation. As well there is an oig review as well. We are going to benefit from internal review as opposed to external reviews. We are committed to Continuous Improvement to do better. To follow up on that could you explain it really quickly how did the fda improve its Consumer Complaint and whistleblower complaint process . A process he changed regard to Consumer Complaints we get a lot of Consumer Complaints at the agency. Thousands of Consumer Complaints. But certain criteria for example if a Consumer Complaint comes in incomes involves an infant. If it involves a death, hospitalization or anything like that that is immediately escalated to leadership i now see those. There is an elevation process based on criteria, vulnerable population, hospitalization, desk death and things like that. Those processes have been put in place. The processes are important given the volume we have a great and the Foods Program we address Something Like over 9000 adverse event Consumer Complaints every year. Theyve a Call Center Response or 25000 calls every year. On the volume of work load optimally as we can. I appreciate that for the internal review also revealed scientific gaps understanding of the contamination spread of carotid vector hindered fdas response. To remedy some the knowledge gaps and to improve corona sampling and testing procedures. We can prevent this from happening again. We truly print information deficit here. Modifiable disease. For Consumer Complaints. But if that was unusual or not we do not know the denominator is. Having and notify will disease would completely change the way we could have approached this situation but not much was known about the pathogen. One of the things we did National Advisory committee on biological criteria and food to ask them a whole series of questions about corona baxter. Weve given them a charge the committee is meeting next week to give us in progress what they have learned. To understand this bacteria what do we know about its prevalence. Where is it located . What are the sources of contamination . Our lack of whole genome sequencing has hindered us. We dont have anywhere near the tools like wisteria or ecolab went to advance science here with me great progress since the month since this has occurred. I really appreciate that it is clear fda needs adequate resources to prevent this from happening again. I just want to say as a mom who had to supplement my Breast Feeding for my son to thrive, i know how important this issue is if her all over this country. This committee is really focused on making sure this does not happen again. Thank you. Thank you, we agreed we never want to have this happen again. Thank you i now recognize myself. I am still confused and need you to help me too connect the dots. Why did it take until january 31 for the fda to inspect the abbott facility in sturgis, michigan not only reports of cronobacter started in september we now know osha transmitted a workplace complaint to fda in february 20 what outlining the unsanitary conditions. I just need help filling in the gaps. Fda 2021 investigation of operation manual states quote unquote all complaints involving either infant formula or baby food are to be thoroughly investigated at a high priority basis. I just think four months is a big delay. Can you help me fill in the timeline there . Typically our goal is to inspect annually for infant formula manufacturers. Our normal highrisk facilities are inspected once every three years in non highrisk food sellers are inspected once every five years under the act Congress Gave us. If that pharma a high priority thats where our goal is annually. With regard to the sturgis facility we were in there in september. We found in deficiencies but the industry committed to address those. We typically give time to industry to address those. They didnt. She went in there at the original september 21 that was eight normal regular scheduled visit so to speak . Right. After that summary unfortunately some babies passed away and there were more complaints right between that september and january. Why the four month lag . A high level im happy to address the timing first of all again i am not the head of the inspector but i can say would understand what the dates are what i know. We received the first Consumer Complaint at the same time the investigators were there. That was followed up on. We always try to interview the parents, the product. She did not know about cronobacter on the 21st. You got reports after that. The information the case report came in but we would not have necessarily polled the product, test of the product, scene of the evidence pattern was that information did not commit until october just to be clear. All give you october. We did not do anything until january. Corrected. And then in october a whistleblower complaint came in. As i indicated the staff received it, they acknowledged it, they reviewed it. The staff were working on it. Then they attempted to interview the whistleblower as you know they whistleblower based on timing on their end was not available. They had it since october it did not have anything until january very quickly tried to schedule the inspection in december it was attempted to be scheduled but abbott declined to have the inspection done they had a covid outbreak in their facility. And then we finally got in there. Looking at that we agree with you those timelines are less than ideal. As i put in place a whole processes based on Lessons Learned from this. Once we got in there and saw the conditions, all of our timelines are met very expeditiously. I agree with you in the months leading up to that time this timelines couldve been more ideal. Thank you. And make few minutes i am still troubled by during coed. I think food is especially in this a day age especially for underserved communities. I showed 20 of 23 infant formula production packing distribution plants in the u. S. Were not inspected for nearly two years. Are we blaming that on covid . Those numbers do not agree with what i have. We got those numbers in the fda progress we should take that question back. Again the outcome with data of our office of Regulatory Affairs progress we have is your number with her 23, or they all inspected and timely fashion . Some of that may be calendar years versus fiscal years we should take the numbers and get back. My understanding we did inspect even in the early part of covid five different infant formula facilities. Boxers 23 progressive going to get on the fiber think at that point december 21. Thus we should take the numbers back. It was five of 21. Can we agree at least thats kind of a problem . For some sorry to hear the last thing you said progress even if it is 521 and your numbers are correct five of 21 what was everyone doing . [laughter] i know its covid projects they were inspecting the prioritize inspections for their many criteria per. Baby four is not prioritized the bits need to change . Certain manufactures were it was based upon a respectable history. Whether they had been complaints associated with product before formula manufacturer long history of no complaints they might not have been prioritize in that period of time in 2020. Alright, did abbott have complaints . Did abbott have complaints . We ask abbott was going to the facilities. In fact every time. Did they have complaints . What you should ask abbott that question progressive asking you, do you know any complaints from abbott you are the fda you are the inspection of the regulatory . Lets we get the Consumer Complaints. They dont have any . Report them to abbott we tell abbott if we get a Consumer Complaint to correct it we get any . Yes the saloons we talked about. Then when we are in the plant we ask abbott if they have had any similar complaints for quick she would not done inspection with abbott who had had complaints for the prior two years. My time is up i will yield back. I think we are done on questions. Going shows your closing here. I without recognizing the sleeve or closing statements, thank you. Thank you madame chairwoman for holding the steering on such an important issue. Acute doctor for your testimony. Half of our subcommittee have been on this topic so far. We have identified the necessary areas for improvement. But now we need to put this information into action but first we do pass a Bipartisan Legislation a process that makes fda aware of bacterial contamination and realtime. They will have no excuse and to take action on contamination immediately. Moved to continue to work with fda and actually listen to them but at the age should not be hampered by congressional and action. We and keep the lines of communication open to ensure fda can do his job. Third, we need to collect better data on cronobacter we can better stop its spread. While i project the steps at the is taken so far to increase our understanding this Public Health issue will not be solved with Just One Agency and one approach. Finally we have to put our money where our mouth is. With a stronger system lead to fully fund the fda to protect infants who use formulas. Now set the time for fda for cuts to the fda while expecting them to modernize and streamline their systems. That is deafly not going to happen with 22 acrosstheboard cuts. I cut that ultimate 1. 7 million women, in the children will lose nutrition assistance through wic. I believe the chairwoman and i, will have the same goals avoid infant formula shortage repeat. There are things that should be easy for members of both of our parties to agree and there are some things that will require longer. They can find a path for the saved kids lies that it will all be worth it. Thank you and i yield back. Think it messily i recognize myself or closing statement. Today, we have heard excuses be excused from the fda the ability to its job excuses to willingness prioritize. They beat formula shortage. Fda prioritizes it is critical for there is no excuse for these failures. Do recognize the failures are not just onesided. When you have to first admit how we had a problem before we can fix it. There are no excuses fda has an important job but what American People pay them to do and more partly trust them to do. If the fda is not going to the job we have serious decisions to make with the fda is responsible for keeping americas food safe. When especially good food safety enough responsibility. Enough attention. Especially when it comes to baby formula. Last of the trust was broken families lost precious children as a result. Those lights can never be replaced we owe it to demand answers but that is what the crisis expose significant failures within the fda Regulatory Oversight process. This we need to fix. This is happened again. Can congress do better . It abbott to better quest mark from the fda better . Forget all that to better spot for the fda has promised it will do better break time will tell and i hope it well but will be closely following fda effort to revamp team and food program. That is critical. The growing list of vacancies and the fda food safety programs. These vacancies are concerning. But ultimately there needs to be a culture change at the fda. The fda needs to reconsider what they deem critical with the American People deem as critical. I think some of those changes will help bridge the gap in these timelines but i am and will be in communication with the fda to monitor the process of hiring a Deputy Commissioner of human foods proved an oversight will continue print close to go to thinker panels once again for your important testimony today. I appreciate it. I really hope you enjoy your retirement it is wild deserved without objection will have five days to submit materials at additional written questions for the witnesses which will be forwarded to the witnesses for their response for this no further business without objection the subcommittees aunt. Thank you so much