Transcripts For CSPAN2 Hearing On The FDAs Foreign Drug Manufacturing Inspection Process 20240712

I thought this happened. Good afternoon everybody i want to welcome everyone to the finance Committee Oversight hearing the fda foreign drug manufacturing inspection process. And the taxpayers whether medicare or medicaid and second and the jurisdiction under trade with the responsibility that only Quality Pharmaceuticals that responsibility is heightened now that we are living through the covid pandemic whether were in the midst of a pandemic the supplychain and starting june of last year on this issue to secretary as are in the commissioner. I ask a series of questions related to manufacturing facilities overseas to file dosages for drugs and pharmaceutical ingredients and throughout the day also with the fda managing its inspection regime that says the fda does conduct some unannounced inspections on the frequency but the gao and 2019 that they estimated they generally provided 12 weeks of notice before the inspection for them to do their jobs and 12 weeks common sense tells me there is plenty of time to doctor facility and it passes inspection. Some are still caught. That is how bad it is. And have to do something about it the end result that consumers put at risk. And to have 46 percent with those facilities and the api and in the final form that means only 50 percent of the sites are located outside the United States where did the api come from cracks and 13 percent comes from tried on china and combined thats more than any other country and overall more than 70 percent of the facilities that make api are located overseas coupled with the covid pandemic have garnered a lot of attention including what might need to be done from a National Security standpoint. It does not make clear what needs to be done about a drug safety perspective we need to haveve the robust stand in for an Inspection Program both of those have serious Quality Control programs we all remember the recall where the drug was found they used rocket fuel and the facilities in china and india also dont forget heparan thats a scandal all by itself. In that case patients undergoing dialysis have severe and lifethreatening side effects because the manufacturing plant in china introduced a toxin into the production chain. Hundreds of people died and hundreds were sick and then in india manufacturer with the production chain expose drugs and by a penicillin to use the api from facilities that were not approved by the fda the company also manufactured lipitor and shut down because i cannot explain why some of those tablets have pieces of glass in them. I fear these examples are just the tip of the iceberg. But at the same time to have a strong enforcement regime and in february of this yearth the fda commissioner told me that fiscal year 2018 the center for drug evaluation and research issued almost five times as many warning letters to the human drug manufacturers as compared to 2015. He said thats a sign the fda can better use its resources to identify problems. Stay aggressive and dont hesitate and be more aggressive. On the front end, that process should have unannounced inspection overseas. After all why would we give manufacturers time to prepare their facilities for inspection . They ought to be looking over their shoulder every day. That wouldld keep them honest. During the Obama Administration the fda started the India Pilot Program allowing for no warning inspections a couple days worth of warning the fda issued a 60 percent increase of official action indicated findings and in 2015 the Obama Administration shut the Pilot Program down and i believe there is no explanation of why. And as a victim of the smaller success. The democratic administrations have come up short. And for multiple administrations to prove this is bipartisan. And administrations have struggled to fill vacancies in Foreign Offices and what we found out over a year or more of investigations. Today we have witnesses from the fda who can speech all these issues and how the pandemic has impacted their work on the first panel we have fda witnesses and the gao and on the second panel we have private Sector Companies thank you for being here. And then to follow up with ofther hearing soon another aspect of the medical supply chain specifically with the increase of faulty equipment and that is separate from what we will discuss today. I want to say two things. First, thank you to fda officials who work tirelessly to inspect facilities overseas. Second regardless of party we must have an honest discussion of the government shortcomings so we can better understand what we as congress can do to ensure safety for the taxpayers. After all we work for them and must always answer to them. Before i introduce the Ranking Member that we have one more vote starting at 2 15 p. M. So are you ready . I am mr. Chairman would you like me to proceed . Please do. The finance committee is holding its first meeting. And with the fda failure to adequately inspect foreign drug manufacturers and the head of the fda to face those tough questions on this issue. The commissioner is not with us today for one reason. Because the Trump Administration blocked the testimony. And to prevent the committee of holding the point person to for the fda accountable. I also asked the committee to let one journalist testify because she has literally written the book on this issue and unfortunately that has not happened so i would ask for unanimous consent to enter into the record on this subject. Without objection so ordered. With the committee needs from this hearing covid19 is ripping through Nursing Homes killing thousandss of americans each week. And at near depression levels. And then to be outraged by the murder george floyd the president is advocating for more violence and escalation as the nation suffers. And over the last few days will then throughout society. And then dealing with healthcare im going to start my remarks with an immediate piece of Urgent Health care reform. Covid19 has at the Africanamerican Community harder than virtually any other group of americans. I would note the recent analysis to show those counties that are majority black and three times the rate of infection and six times the rate off death and those that are in the majority the Racial Injustice status quo and with this Healthcare System working against black people and when with cruel experiments of black human beings and its on the Africanamerican Community there is a risk for example and then those vaccination rates in the Africanamerican Community because many in the community for understandable reasons do not believe American Healthcare is going to give them a fair shake. I want too make something very clear right now this committee has muscle when it comes to federal healthcare spending and to do something about what i just described 2 trillion a spending over flagship programs like medicare or medicaid are inside the jurisdiction the finance committee. Calling on this committee to come together to use all of that power and authority to right the wrongs of the past that i described this afternoon. So to watch to get this done and then to be on one specific example the fda teaming up to put americans in danger. So talk about hydroxychloroquine and this old malaria adjourned to have covid19 without any valid evidence as the ultimate game changer against the horrible pandemic. They bowed to pressure and that emergency use authorization of the drug threw open the doors to tens of millions of those that were directly related to this hearing these pills that were manufactured inside facilities in india. And failed the fda inspection or have never been inspected at all. Studies have now shown the drug has no benefit for Covid Patients and with that mortality the fda warned against using the drug now potentially the lifethreatening the fda says and improve manufacturing facilities. And those the episodes posed fundamental threats without objection to the new england journal of medicine put into the record. So ordered spent lots of americans take this medication to treat lupus and Rheumatoid Arthritis to prescribe better doctors and counting on having a safe supply of medication and donald trump taking that away and repeated far right punditssi with tens of millions of hydroxychloroquine that may or may not be safe its not clear there is a system in place to distinguish them from other stockpiles so if you talk about fda failures a greater risk for americans hydroxychloroquine is a case in point. Also with the covid19 body count and those that pose a danger to healthcare workers and the number of fda inspectors for drug manufacturing facilities with the Trump Administration. This committee with bipartisan interest have seen improvements of the fda to make sense for us to build the drug manufacturing capacity in america and with the covid19 drug manufacturing has no experience and no facilities in which to manufacture them. That is not ago good enough plan to help Covid Patients that are suffering right now and also to raise questions how the administration what handle a vaccine if it becomes available. There is much to account for on this issue. The Trump Administration continuing effort to stonewall our oversight by blocking the commissioner by answer your questions today is preventing real actual accountability i look forward to their testimony. Thank you mr. Chairman. One clarification the Trump Administration did allow but we decided for the purpose of the issues of this hearing which deal with the importation of some less than eiquality products from Foreign Countries that have fda witnesses i am going to introduce the associate commissioner for Global Policy and strategy with executive oversight and strategic leadership and policy to Global Operation activity and engagement with International Stakeholders with the strategy that is comprised of of Global Operationsns and trade those internationaln arrangements and dedicated to expanding the reach of the fda global agenda the associate commissioner for Regulatory Affairs and have responsibility for 5000 staff with the Regulatory Affairs and then witha the Product Center of the responsibility including inspections and investigations and criminalal investigations and the enforcement and import operations and the Deputy Director at the office and as a Board Certified physician generic drugse and those that the known risk and then to oversee the gao offices and the market is associated with that includingng opioids and in 2012 related to science and agriculture production with the gao Natural Resource and environment covered costcutting topics such as antibiotic resistance and reducing preparation let the witnesses know we are under time restrictions at the moment that the three fda witnesses will try to keep their Opening Statements at seven. Five minutes. Mr. Chairman . If i could, just for one minut minute, we still feel real accountability with the issues we are discussing today to have the doctor and all of the employees that you just describedbe to recognize the role at the fda they all report to doctor hahn so we have a difference of opinion its important thatay he is not with us today and he is accountable and then i respond briefly provide appreciate thein chance. And to cover the bases in this hearing. And members to the committee and the associate for strategy as mr. Grassley noted only the Global Policy and strategy and policy direction to the Global Operations and with those national stakeholders. And with the pharmaceutical oversight that over the past 30 years pharmaceutical manufacturing is the Global Enterprise and beginning in the 1970s industry moved away from the mainland United States first to puerto rico. And then to europe and china and india that offer significantly lower labor energy and transportation costs. The fda has responded with a comprehensive strategy with the oversight of medical problems and then those are the following to develop new enforcement and regulatory tools and increasing collaboration with regulators and other stakeholders and to zedevelop International Harmonized standards and convergence and educating for an industry about fda requirements and increasing transparency and accountability in the supply chain. The responsibility for addressing the global challenges is distributed across the agency my office aserves as a focal point for information sharing and a point of access to multilateral organizations with those related products and to in those arrangements nsat facilitate for inspections with global regulatory counterparts and with that foreignbased and then to conduct inspections and unannounced and also the counterparts to engage in outreach and education and good manufacturing practices to provide boots on the ground and analysis with fda headquarters. And with that historical recognition and European Union that is beginning to yield benefits the mra enables the authorities to rely on information for routine drug inspections within others borders. And then the nra will help to further minimize the on ns inspections and to other parts of the world where there may be greater risk. And then to protect the reliability and availability of drugs for americans. And then to bes. Here and answer questions. Ranking member members of the committee im associate commissioner of revelatoryis Affairs Thank you for the opportunity for the drug Inspection Program and it is the foundation of all of the work in americans can be confident in the quality of fda related product and then to be produced in the United States or overseas products mustpr undergo the same rigorous prosperous and the information must be fully reviewed by the highly trained scientific staff. The fda inspects facilities around the world and its important for us to modernize the policies that companies regardless of where they are located with the strict standards the fda drug Inspection Program shifted from one focus on the usbased facility through the early 2000s that since 2015 have conducted more than those drug inspections and with domestic oversight the strategy to oversee the safety of imported products is to maximize the agencys Public Health impact by aligning resources and to tailor the use of those regulatorys accordingly the fda does not draw the Enforcement Mechanisms to have a comparable level of infrastructure and for example if a Domestic Firm refuses inspection we can see can inspection warrant we do not have the same capacity as Foreign Countries to the agency utilizes additional tools to ensure the safety and efficacy ofof product. And in those targeting systems and import certification and screening to identify product and then to conduct Foreign Inspections the fda optimizes foreign manufacturers by leveraging strong regulatory systems and the supply chain. During the covid19 pandemic the fdada continues to implement to approachc and postpone foreign and domestic routine surveillance facility inspections this will continue as conditions warrant with the certainn of missioncritical inspections including preapproval and importantly during this interim. We are evaluating additional ways to conduct our work to protect the firms and the fda staff. For the opportuno discuss our work on the fda drug inspectionre program. The covid19 pandemic has called greater attention to the United States reliance on foreign drug manufacturers and highlights the importance of a secure pharmaceutical supply chain. Like most manufactured in the u. S. Market, many that are important for treating covid19 arees manufactured overseas. This includes antibiotics for secondary respiratory infections and sedatives for ventilating patients. Today, the majority of establishments manufacturing drugss or overseas. Americans must have access to safe and effective drugs. However, we have longstanding concerns about the ability to oversee up late increasingly Global Supply chain. 1998 when he reported they had significant problems managing the inspection data and those of the foreign establishment compared to what they did domestically. Sincetsy. Y. Then we have returnd found problems persist. The data is non sufficient to know how many foreign drug establishments were subject to inspection. In addition, they continued to inspect relatively to the foreign establishment and when n did it, investigators faced challenges that influenced how the inspections were conducted. For example unlike in the u. S. Where the establishment has no noticed that an investigator is coming the fda routinely gave manufacturers significant notice. And the investigators relied on englishspeaking employees of the establishment that they were inspecting to translate the key documents, including those demonstrating compliance of good manufacturing practices. In 2010 we found while fda was conducting more overseas, many establishments still have never been inspected. We also identified shortcomings in the operations of the Foreign Offices fda opened to provide the agency with an country in cy information and inspection capability. In 2010 and 2016 we found the offictheofficers face a vacancys raising questions about the effectiveness. T as a result of these and other challenges, we have at the oversight of medical products to the highrisk list. Last december when he reported that from 2012 to 2016 fda increased the number of inspections conducted in in 2015 had for the first time conducted more Foreign Inspections and domestic. A growing percentage of these were in china and india is the largest number of establishments unitedtured for the states. However, as senator grassley noted, we also found that they still provided up to three months advance notice to most inspections which could give establishments the chance to fix the problem before investigators arrived. They also continued to face cone challenges when they travel overseas. As we learned in india and china and in conversation with investigators, the single investigator often had to inspect manufacturing campus is covering hundreds of acres of land in rural areas. Most have little flexibility to extend their time because travel schedules require backtoback inspections. Fda also continued to send inspectors into establishments without translators. Wed were told this was particularly difficult in japan and china. Re investigators also had to rely on translators provided by the same drug manufacturers that they were inspecting, raising questions about the accuracy of the information. One investigator plus they had to resort to a translation application on your phone. We also found that from 2015 to 2018, both foreign and domestic inspections have decreased. Fda attributed to decline the vacancies among the investigators available to conduct these investigations. Swhile fda has made strides ovr the years, these persistent challenges raise questions about its ability to conduct in inspections equivalent to post them here in the United States. The pandemic has further complicated the playing field. In march as it has already been noted the agency announced a postponed nearly all inspections of the foreign manufacturing establishment. While the note that it has other tools to ensure the safety of the drug supply, the lack of the nfreign inspections remove a critical source of information about the quality of the drugs that are manufactured for the u. S. Market. Further, it is unclear the effect that it will have on the ability to fulfill those vacancies both in the Foreign Office is in among the usbased inspectors to conduct most of the inspections overseas. And it is unclear the effect on the ability to gather that critical information to help determine for example the establishments are at highermi risk. Thank you members of the committee for holding the hearing. I conclude my prepared remarks and im happy to answer any questions they may have. Thank you for your testimony. I see one of your credentials is having taught at houston state university, so its good to have you as a witness here today. The Deputy Director of regulatory programs for the center for drug evaluationto and research. [inaudible] chairman grassley, Ranking Member wyden and members of the committee come on the Deputy Director of regulatory programs at the center for drug evaluation and research at the fda. Thank you for inviting me to participate in this important discussion. Protecting the safety, quality and availability of medicine for americans is at the heart of everything we do at the fda. To accomplish this we used several tools. Todays hearing is focused on f inspections which are an important part of the robust approach to oversee safety and quality of the fda regulated products. Ewhile important they are not te only impetus for the drug quantity. First and foremost the First Manufacturing have the primary responsibility to reliably produce products. They are required to comply with good manufacturing practices to assure the identity, strength and tyranny of their products and to provide routine quality testing. The fda supports this work by providing guidance to the best manufacturing practices, adversely assessing events for the manufacturing issues inductively surveilling the drug quality and applying postmarket study requirements to identify and evaluate emerging. The goal of all of these efforts is to protect the Public Health. We also partner with the fda to maximize the value of those inspections. Additionally, other Safety Initiatives include proactive testing by the fda selected pharmaceutical ingredients and dosage in the stateoftheart laboratories. Only a small percentage, about 1 of drugs that are tested failed to meet the established quality specifications. Additionally, the manufacturing we do identify or similar for both the u. S. And foreign facilities. We also collect data about the safety and quality of drugs once they are on the market just this just this week we released the fifth annual report entitled drug safety priorities, 2019 detailing the programs and activities in highlighting the versatility of the drug safety ainitiatives. All of these checks and re checks arear needed because most of the pharmaceutical manufacturing stilmanufacturings with decadesold approaches to technologies. The vision is to spur the industry to modernize the quality can bso thequality can d reliably built into each. This includes initiatives to encourage advanced Manufacturing Technologies and Quality Management. While time doesnt permit me to go into detail, i would welcome the opportunity to discuss these proactive strategies. We believe they would yield important benefit for the drug quality and safety. In particular, these advanced manufacturing techniques could provide safer and more secure drug supply chains and may promote a shift to more u. S. Domestic pharmaceutical manufacturing. I look forward to working with the committee to predict the reliability and availability of drugs and to strengthen investments in modern manufacturing technology. Thank you very much. Ve thank you. Now we will go to rounds of questioning. The chairman has gone to vote, said hes asked me to chair in his absence. Id like to maybe change the topic just slightly. But if it seems to me there is one thing covid19 has taught us, its that we cannot rely on supply chains coming from outside of your country. Weve long become accustomed to being able to buy Cheaper Products because they are manufactured in other countriesu with over overhead, labor and other costs but obviously this pandemic has demonstrated at least to me the importance of on shoring a lot of our most basic functions, things like medical equipment, things like drugs, and id like to get the reaction of the witnesses to. Am i wrong or do you think we are stuck with this dispersed Global Supplychain that can be disrupted in the next pandemic or do you think that there are steps as a matter of sound Public Policy congress over to the setter to bring that capacity for manufacturing back onshore . Would you care to take a stab at . First, American Consumers should know the u. S. Drug supply is safe and supply chains are secure. The u. S. Drug supply is among the safest in the world. Iworld. Fda thoroughly review his drug applications to ensure that medications are safe and effective before they reach the market and oversee drug quality postapproval. Excuse me just a second. Did you see the supplychain or secure . Yes. How much of our active pharmaceutical ingredients for the drugs in america depend on china cracks im going to refer to doug. Can you add ton that . And how much do we depend on go ahead. The acting Pharmaceuticals Ingredients the u. S. Provides about 28 , china about 13 and india, 18 . So, they are as secure as the supply from china and india at least for the percentage that they contribute. But i seem to remember that there was at least one instance during the pandemic where hydroxychloroquine was being courted by one of our countries that ordinarily is the source for the drug. You may remember that incorrectly, or do you recall that . Ofwe do have imports products, and we use additional tools to help complement our inspections including remote assessments of foreign manufacturing. Im sorry, im not talking about inspections now. Im sorry if i wasnt clear. Im talking about in the midst of the next pandemic, what percentage of the pharmaceuticals, the active or mystical ingredients thapermisse depend upon in the united statea orbl vulnerable or in jeopardy because thats supplychain, that supply comes from a country would sawith a say in this inste where china obviously has been the main source of personal protective equipment, but after the virus broke out, they obviously delayed notifying the World Health Organization and other countries around the world and for the professional equipment it seems to me the same thing could happen to our drug supply. Am i wrong . Before an establishment in the domestic establishments over held to the same standards. The standards are the same whether you are foreign or domestic. We follow the same process to inspect them. We have the same standards to inspect them and they are held to the same high standards of fda requirements. So the percentage of active pharmaceutical ingredients that from china if for some reason china is either unwilling or unable to continue the supply doesnt that strike you as a former ability for the United States and publichealth . It would be good to have redundant systems. Is this what they might do as a matter of sound Public Policy to encourage more manufacturing of active pharmaceutical ingredients in the United States as opposed to depending on these supplychain supersedes . We do need a robust reliable supply source for all of drugs and the American Public. No question at all. A these things would encourage additional on shoring. As we mentioned at the testimony, we believe the advanced manufacturing practices that the u. S. Firms currently employ a en gander to the extene could encourage the adoption of those that would reduce cost. It would reduce Environmental Impact by reducing the size and it could potentially improvefa e security by reducing the length of the supplychain and we believe there would be a Good Business case potentially to make the decision to offshore at those factories and bring them back tosese the u. S. With the nt result that we would see the additional redundancy and increased security that you are rightly asking on how to sympathize. I couldnt pass the opportunity to ask you those questions. I appreciate your answer and i trust that at some point the finance committee and the senate and congress as a whole will take upp how we reduce the vulnerability to the supplychain staff we have seen as a risk to our Public Health andbl our ability to deal with e risks like this pandemic to the benefit of the American People. Thank you mr. Chairman and i will take it back over to you. Thank you for taking over why we voted. Im going to start with a the Government Accountability office has noted that almost all domestic inspections are unannounced. However, the fda often preannounce is Foreign Inspections in some cases fda has provided 12 weeks of notice before the foreign inspection. Question number one by providing advanced warning doesnt it give the doctors time to hide the true nature of the problems at their facilities. In general, domestic surveillance inspections are almost alwayss unannounced, whereas the foreign establishments generally receive advance notice of the surveillance inspections. Given the importance of avoiding a potential refusal and waste of resources, most Foreign Inspections are preannounced and this is intended to verify that the facility is indeed interesting over the jurisdiction under the fda to facilitate the inspection process and ensure appropriate records of personnel will be made available. We also announced during the jurisdictional differences between domestic and foreign the announcement process documents with the agreement to allow them to inspect. The fda takes a different course of action and in the domestic arena the fda can seek and inspection warrant to enter the facility. However, due to the jurisdictional differences, the fda can refuse products at the border or not grant an approval, but the fda doesnt have the authority to compel to enter and inspect. In mid2019, we did initiate a change to the it system to accurately record the data of weather and inspection was announced for unannounced. Efforts are underway to include a data field in the database and the next version scheduled for this june tors accurately record weather and inspection is announced for unannounced. Having this accurate data will enable a critical evaluation of the outcome ofat inspections alo typically domestic sites are not announced in, or typically unannounced, we do conduct this in the i foreign arena. I want all three people to answer this do any of you know why the Obama Administration shut down the Pilot Program . Thank you, senator grassley, for that question. It was rolled out only in one country. Unit had no metrics by which we could evaluate whether it was a success or not and it was collecting data with inherent bias in that we performed unannounced inspections abroad and investigate had already determined that those firms had significant problems. We did, however, implement some best practices we determined were useful from the program. First, we stopped having firms issue letters so we could get tt visa for the investigators and the second we stopped having them make a to good house elects for us and most importantly, we began a program whereby the investigator going out received a preapproval briefing from colleagues to improve the efficiency and effectiveness of the inspection. I ask all three of you to respond to that but because of time, would unannounced Foreign Inspections improve the fda ability to oversee the drug supplychain andrugsupplychainy not . We do feel that they are vern important, and as it is noted there are very few ended does raise questions aboutse what weo here in the United States. Should they gain visibility into the active pharmaceutical supplier for the final dosage form facilities would that bettertt health oversee the supplychain and if not, why not understanding this is very important and challenging and quite complex. They cangr come from many different sources and being able to enhance the oversight and visibility into that supplychain could be something that is valuable to understanding theto safety of te drug. Okay, my time is up. Senator wyden. . Let me start with you. On march 28 of this year, so this is on the trump d ministrations watch, the fda has an emergency use authorization allowing the drugs for the treatment of covid19. The whistleblower reported theyve never been inspected by the fda. Another source allowed into the United States the company that is on the import alert prohibited from bringing these exact drugs to the United States in 2015. These are drugs that have long been known to carry cardiac health risks. There wasnt any medical evidence that they were effective in the treatment of covid19. My first question to you is as it dangerous up until a few days ago we couldnt because they were on the import alert. The. Is it dangerous to americans to import from the facilities that have never been inspected . Yes or no, please . It is dangerous for any country not inspected. The former head until he was fired by veteran administration is now a whistleblower and said the process for approving the drug wasnt based on science, it was based on politics. So, let me ask you because it isnt going to get you into the politics here, is that how the process is supposed to work . But i described, is that the way thatpp things are traditionally supposed to play out to protect interest . I just described to do with the process. Is the process that i described the way things are supposed to work . We havent looked into that and we have ongoing work looking at the authorizations and we would be happy to address that issue once we looked to see if that is the process used. So youve ar you are going tt whether this process ive described is like the traditional process thats based on science because the whistleblower said this does not resemblest science and i asked u about whether the processes were dangerous and you told me yes, so its kind of hard to see how something thats dangerous is somehow in lin inline with thes that we will wait and see. One of the problems created to talk up has created shortages of the drug for americans who rely on them for illnesses unrelated to covid19. How can those americans be sure that the drugs they depend on our safe when drugs we know are not inspected by the fda are coming into the country . There is no country of origin labeling so as a consumer you wouldnt know if it came from pakistan or an inspected facility. Said that as yet another factor in raising concerns about how all these practices we are talking about from march and be succeeding weeks represent real danger, and i appreciate your [inaudible] youve got to have a person here that can actually challenge [inaudible] short of medical supplies and search for the respirators has been a nightmare for the state after they brought the respirators they offered under the emergency use h authorizatin the fda then removed them from the approval listed at the same Time Companies that have been trying to get the approval have been unable to do so. How do they make sure they get the okay to ship to america and manufacture in the United States and my state and want to make the same products how does that make sense . The fda does have oversight of these devices and i dont have an answer. Its the decision they make in that authority and in coordination with thee task force, so they were in support of this. I just hope we can get that changed becauset to me the unitd states cannot get a call returned and that means that something is out of whack. And again, the person that is accountable for changing the kind of problems we dont find and thats why i felt so strongly. Next person on a firstcome first serve basis. I want to go back to the line of questioning the senator was pursuing. Its been fully made in china or containing. Further i believe in this report was determined that none of these drugs are o considered critical drugs and i think the criteria is that there is no available substitute. So is that your understanding that makes it sound as though [inaudible] let me answer by going back to where we found ourselves in march. As we typically responded to win when the drug shortages occur i have a staff whose job 247 is to reach out to manufacturers identify possible sources for the products. We go back and what we found ourselves in is the situation where we were looking to identify the products that were essential. The Drug Shortage Team along with work and other offices went to work looking at the available products. Wherevewhere were they made, whs available, and the short answer to that question is yes, you are right. China had a small footprint as far as the creation of manufacturing of those drugs. Are you saying that these 20 drugs these are just within the universe of drugs that are for the purpose of treating covid19, or is it more broad than that . Great question and i apologize if i wasnt clear. Definitely broader than that. We knew less than we do now about the impact. We knew much less than we know now about the specific drugs that are needed and so our focus was on products that we knew were and shortage and those we anticipated would likely be needed in hospitals. More would be needed. My question is focusing much more broadly than just on covid19. I want to understand the American Public has an understandable concern about whether or not and to what extent we could be reliant on any one country and most of all, an adversarial country on something as important as lifesaving medicines but it sounds to me like from this report,ch the fda conclusion is that there are no drugs that are considered critical drugs in other words drugs for which there is no substitute on which wewe rely on china and less than one tenth of 1 of all drugs are sole sourced from china or containing one solely sourced from china said if i have those basic facts correct . I want to agree with your focus on the larger issue of the total availability. Whether a product comes from a specific country or not it is important. I am not minimizing that, but its more importantth for me asa u. S. Federal drug officials to make sure the drug is available from somewhere to meet the needs of the American Public. So, if it is china or france, but i am interested in knowing the total available market, can it meet the needs of the u. S. Or not. And if it is done with high quality that that is the peace im going to want to stay focused on. So we heard from Healthcare Providers about shortages of drugs they wanted to be able to administer much of which was related. This pain medicine, antibiotics and there were shortages. So can you characterize is it just because there was a sudden spike or were there other factors contributing to the shortage is . Thats a terrific question. Short answer, we dont know all of the factors that led to that distribution challenge or whether iwhetherit was related d demand. There was a variety of different factors that drove the shortages that were extremely serious. Where i started before, we focused on the larger market and that has been our goal. We have to start worrying. Im probably out of time. But on this question are you aware of any case where a source of these medicines from overseas that in the country or manufacturer overseas decided for whatever reason not to distribute to the United States medicines they normally would have that the American Consumers need is . Im not aware of any case where the country. Through on that right to withhold medicines. Thank you very much, mr. Chairman. You back. Senator stabenow. Okay. I agree they should increase the inspection to make sure that its safe and effective. I do think its importantta to note that in the current budget. It is of a great concern when they called for budget cuts so we certainly need to make sure we are not doing that. This is obviously an important topic with people having lost their lives in the United States because of covid19, over 5,000 people in michigan alone, and we have an urgent need to address this major healthcare pandemic and now on top of Everything Else, we have another huge urgent issue which is what is happening in terms of africanamericans in this country and not only [inaudible] and also as a result of the horrific murder of george floyd. Violence like this against africanamericans has gone on too often and for way too long. Its also a health issue where 14 are africanamerican. This is a huge issue so we have all got to come together with accountability and change. My colleagues have talked a couple of times about what we need to do in terms of bringing pharmaceutical drugs and needed medicine back to the United States. I couldnt agree more that we need to do that. I do want to point out though in the document i went out by the republicans in 2017 there were trillions of dollars of cuts in the pharmaceutical industry thatsli not saying that its required the Companies Either to where the cost of Prescription Drugs or to bring the jobs back and the medicine back to the United States and the structure of the global minimum tax profession exempts the first 10 of income from physical assets which creates an incentive to offshore. We could start by getting rid of that and the focus of what we need to do here in the United States. But they speak specifically to the fda where i am very concerned and i know people in michigan. We need them to be making decisions in the best interest. Its the right thing to do basee on science. We all know now about the hydroxychloroquine and the fda provided the authorization for thed drug march 28 and then now on the website to indicate there is no evidence that it treats covid19 and in fact actually could cause a loss of life. But the emergency use authorization ways to prevent goods manufacturing practices that weve talked about today allowing them to be imported from the manufacturing facilities. Is that correct . Yes or no is fine. The fda has inspected manufacturers as recently as april of 2020 and inspection of an alternative manufacturer was actually conducted by the india global office. Did you share the concerns when talking about the safety issues, the question around this particular drug . Can you go onto the next questions we can go to the next member . I havent had those discussions [inaudible] what they say mr. Chairman i realize ive run out of time but i would say people are deeply, deeply concerned. We want to be able with the politics and things happening it is a deeper concern. Thank you. Senators sass is next. Senator cantwell. Okay then senator menendez. Okay. Senator carper. I am here mr. Chairman. Just a minute. Go ahead, senator menendez. Thank you mr. Chairman. President trump announced last friday the United States would terminate its relationship with the World Health Organization terminating our relationship with the premiere Global Health organization, the administration is advocating in t my view u. S. Longheld leadership role filled on the world stage, the role that china will be eager to sell. This undermines the safety of americans. We know if we dont work in partnership on the International Community to combat covid19, everywhere all americans will remain at risk. Beyond the work, who is also the central entity to the fight against other Major Health Threats that matter to america americans. It gives hope to the populations around the world facing diseases like polio, malaria, measles, tuberculosis and hiv aids including humanitarian hotspots like the democratic republic of congo. How does the administration intend to address this need, what is the plan . Thank you for that question, senator menendez. I would refer r you to the National Security council or the president ial spokesperson. You had no idea on these issues relating to the World Health Organization . As i said i havent been privy to those conversations. April eighth i sent a letter with the representative pascrell to express concerns about the fda emergency use authorization approvalal process during the pandemic and in particular the fast tracking protocols for the potential treatment promoted by various Administration Officials including thee president. For the drug and device approval is important to ensure that nothing especially pressure from the white house the roads that public trust in the fda. Can you confirm that the fda didnt change these protocols during this pandemic and specific for the hydroxychloroquine . I wasnt in all of the discussions that led up to these authorizations. I canll tell you i am aware of o instance of political influence of any of the decisionmaking. But the question is can you confirm that they did not change its protocols during the pandemic . It is the same as the approach we have taken in the past emergency use authorizations. Explained to the committee how is it that the fda issued emergency approval of hydroxychloroquine to treats covid19 despite the fact that there was no adequate and wellcontrolled trail demonstrating safety and efficacy for these patients. I would want to refer you to the material available on the website that layout the way that the information we had at the time that we approved the emergency use authorization there were Data Available and the decision was made that it supported the emergency use authorization. I should say we continue to collect Additional Information and reevaluate. That led to the drug safety communication. At the end of the day, there were officials noting the lack of Scientific Evidence and sure enough, researchers are raising concerns just this week the who halted its trial due to harmful side effects including heart problems, so we should have the commissioner could explain this discrepancy. Given that we are likely to see additional spikes in cases during the pandemic, with specific sector should be fda take to ensure the continued oversight of the manufacturers and also ensure the safety of the inspectors . It is important that the inspectors have to safety taken into consideration. So i can certainly understand what youre doing in the end. It is important though that the decisions be made on science and they continue to get the critical information that they need to know what establishments may be at risk. So for example in the emergency use authorization we have work that was beginning to look at that. To look alook at the decisionmg advocacy if any criteria changed. We reported thathey reported tho maintain good criteria when you take a drastic step like that allowingke an importer to be abe to have a drug like hydroxychloroquine coming to the United States. So in the emergency they still need to be very careful moving quickly during this unprecedented time to ensure they follow the steps they put in place. Is the senatorse ravi . Senator cantwell . Okay. Senator carper. Mr. Chairman, thank you for the hearing you and senator wyden and the Ranking Member into the witnesses. Especially the one that i think was an undergraduate at the university of science a few years ago. We are happy to welcome you ints the task to pass on to our colleague a sincere appreciation for the work you do every day for the country. Thank you. I have a question or two of the witnesses. I want to make some brief comments. Racial disparities in these countries are rampant and the pandemic is only exasperating some of those issues as we know. People of color are less likely to work a job that will allow them to work from home and in addition to having increased exposure to the virus, people ou color can now have access to insurance, healthy foods, Economic Opportunity to increase their likelihood of a preexisting these make people disproportionately more likely to contract a covid19. 23 of the over 100,000 covid19 deaths in the United States are africanamericans while they make upp about 13 of the american population. Hispanics and latinos make up for of the u. S. Population, but made up 11 of the cases. And the recent killing of george floyd at the hands of police officers, we see yet again another form of devastating effect on the communities of color, and particularly black americans. Americans across the country are feeling deep pain for the devastation and are grieving the loss of loved ones toti covid19 and the loss of george floyd. We can and must do better than this. The first question i have is for you, mary. I would ask, twopart question, does the gao have any work examining racial and ethnic disparities inn health care that would speak to the important issues to consider in light of the response to covid19 . We do. We will begin looking at the disparities specifically for the reasons you mentionedc and that will be important to see the result of the work. We also for example issued a report recently where there was an april the mortality. We are seeing this here with native alaskans and hispanics and black women dying more frequently of the mortality related and with other in the United States. So its very concerning, and its important that as we go forward with covid19, we look not only at the data but how we are collecting it and how we are reporting it because one of the findings we have about the mortality is the data that is ws being collected was very difficult to get in the Realtime Data indicated in time to make it useful for the researchers. During this pandemic right now, we need to be done more quickly. So hopefully they are taking that into consideration. Let me ask you a followup question. Is there any work examining the collection of healthcare data that raises these issues beyond what you justes said . I think number one is ensuring that the data can be collected in a way that can be collated. The data that is collected at the local level would be important. Its shauna needs to be collected in a way that can be standardized and equal across all of the states. This question is to be shared with the doctors. What are you and your colleagues doing to ensure that the rules of the road for a covid19 tests and manufacturers are clear, consistent and stable enough to ensure we as a country can produce a secure efficient and highquality supply tests and ppe . We would continue with our tools to help as these products aree imported. We have additional tools to complement the inspections including utilized and imported screenings of fools where we can adjust based upon different concerns or a specific product. We also conduct a physical examination for product sampling. So we would continue that effort. Do you have anything to add . I dont have anything to add. The devices are regulated in a different center. Our major interactions are the shortage groupser to share whatever shortage information we could obtain with that group to make sure they have that. Thank you. Mr. Chairman, there was an air force Lieutenant Colonel who was in office for a year or two and he went back and is doing great work for the country. [inaudible] before i call on the next senator, without objection, i want to put in the record letters of oversight regarding there for an inspection regime. Those letters were sent on august 17. We have received responses to both including thousands of pages of records and these will be inserted into the record without objection. Now i will go back to senator sachsor or senator cantwell. Is senator cardin ready . I am here mr. Chairman. I want to ask the question as it relates to the supply chain issues and shortage of drugs we that it makes things more challenging with regards to the supply chain and we want to make sure that the supply chain is safe and also that to the extent possible we have the supplies they dont have thees risk factor. We found drug shortages in the United States not because of foreign source but because it just wasnt as profitable to manufacture the particular drugs. And in some cases it was the single u. S. Source for those drugs. Im talking about those dealing with infant safety, cancer, maintenance treatments, dealing with diabetes that we had a a shortage of the domestic supplies because the economics involved. Wewe need to do something about it. But does the fda have a strategy to make sure we dont have drug shortages in this country even when there is adequate supply chain issues but its more the economics of the private drug manufacture deciding not to make enough of the drug available to the population. You raise an incredibly important point. Its basically superimposing new demands on the drug supply on top of existing drug shortage demands. So, we started with a situation where we were challenged for many critically important drugs and then covid hit and we have an additional challenge. Yes, i believe there are things we could do to address the economic disincentives that are leading to choices made by manufacturers either to leave the market or to seek less expensive places of manufacturing. We put out a drug shortage report, as im sure you are aware, last fall. And it laid out some of the solutions that we believe are important. One that i am very fond of and i talk about now is the Quality Management maturity. The idea that if we could find a way to improve the transparency about the quality of the drug supply chain, purchasers could make better choices about what products to choose to pay just a little bit more for her and to be assured that they were highquality, we believe this would help lead the way to get that kind of transparency by at least in part giving us the ability to set up the Rating System to identify products that were manufactured to very high quality, higher than just meeting the minimum standards and would allow manufacturers to advertise that they received the rating with the hope then they would be paid just that little extra more so they could make the choice to manufacture the product instead of the choice to leave the market. So i hope that we look at other ways to allow the shortagesnu to continue is ridiculous and the wealthiest nation in the world and the supply issue we should be able to overcome that together. I hope they would work with us and let us figure out a way to bring this to an end. Now i will go back to the top of the list with senator cantwell if shes not answering then centered around his next. I aim here. I was being polite waiting for senator cantwell. Does the fda will have the authority to do mandatory recall of Prescription Drug . It seems that could help expedite the ability to pull the drug from the market. Do you agree . We dont have mandatory recall authority. Having said that the vast majority we do request recall by a company they do do its only a rare case where people have pushback that need ever recall that i would be happy to talk to about that. We will follow up with the concurrent one congressional and fda also with the pharmaceutical ingredients last year doctor woodcock testified there is a gap in the fda authority relating to the reporting requirements when it comes to overthecounter medications. Can you speak about these gaps and why they are problematic and why the fda is interested in working with congress to fill the gap . At in general terms we are in very similar circumstances to where we were when he testifies of the same issues still exis exist, for those kinds of products they can dip into americans without inspections required by the manufacturers. Sometimes we do inspect those facilities there are ways for us to do that but there are no requirement we call that a loophole we would be happy to work with you on that. We will pursue that. Mr. Chairman i try not to indulge too often or grandstanding and work with colleagues of both parties with substantive questions but i am astounded by the topic of this hearing. We are in crisis people are dying of a disease that spreads among seniors and black and brown workersg keeping our society afloat through essential workers that are expendable and not protected in the workplace while americans continue to die at the hands of the people that are supposed to protect them the president refuses to lead my Senate Colleagues refused to stand up and speakre up. I share the chairmans concern over the weaknesses on the drug supply chain we are the most powerful in the senate this is the first hearing sense the pandemic and the minorities of ms. Taylor and mr. Floyd not everything is about money but that is what this committee has power over it that could make a lot of employment insurance and taxes in the programs could help the Medicare Medicaid shift we should use that power to help the people that make the country work to show all americans including black and brown sisters and brothers that government is on their side we need to put more money directly into those americans pockets instead of trusting it will trickle down to corporations because o, you know that it doesnt trickle down we could be discussing Safety Standards for Nursing Homes 30000 people have lost their lives and women in many people of color are putting their own health care at risk but instead chairman grassley holds a topic outside our jurisdiction one jurisdiction related to the crisis putting covid19 in the name of the hearing doesnt make it about the pandemic this is no exception its time to step in if you believe as i do for the challenge to continually band the art toward justice we should be doing that work. Thinking mr. Chairman spent the only disagreement that i have with senator brown is the fact that this committeeasnlee spends on programs, tens of billions of dollars on medicare and medicaid and Prescription Drugs we have jurisdiction over trade and we ought to make sure we have a qualityy product so obviously this committee has grave concern over the fda ninspection oversea overseas. And when it comes to Everything Else speaking about covid19 this committee has done several things and by 20 percent more money for a medicaid we put 175 million into hospitals as a result and have given out 300 billion of increased unemployment, we have reduced payroll taxes for one year for companies that need more liquidity. We set up a program for increased liquidity for other companies as well beside small businesses. This committee has been very active in the 3 trillion thats already out for the pandemic and the shutdown of the economy and the opening up of the economy as a result of government shutting it down. I think this committee has been very active everything related to the pandemic and will be more active as when we decided seven weeks ago that whatever decisions we were making seven weeks ago we did not know the economy turn around we did not know the condition of the pandemic. We went into it with open eyes if more needed to be done that we would do it. We are in the middle of that process now and when we get to the point to make that add on decision whatever needs to be done, this committee will be active at that particular time but with tens of millions of dollars in the cares act number one hour work in the first step is not done yet. Mr. Chairman if i could reclaim part of my timeul but i have to go back and get my Public Opinion and for those on the phone a lot of the time myd we still see the pain and suffering and a see my colleagues found New Hampshire in pennsylvania i know how hard they work in this committee has to talk about extending Unemployment Benefits and medicare and medicaid and not having no hearings for the last ten weeks when there is so much suffering out there and work to be done but i will stop there. Thank you mr. Chairman. Youre always the person who once the last word so to get on with this hearing ill let you get away with what you always get away with. Thank you mr. Chairman for this hearing. These issues that relate to the fda are verye important. But i dont think we can forget a time in our nations history especially after what happened one week ago i dont think we can fail to remember the murder of george floyd and all the pain and trauma and the anger and protest that have resulted from that death. We cannot simply condemn the actions that killedd them in the criminal Justice System as it relates to the Africanamerican Community. But thats not enough even though we should do more. The trauma and the anger and the protest that have resulted from that death we cannot simply condemn the actions that killed them and lament the failures of the criminal Justice System as it relates to the Africanamerican Community. We should do both but thats not enough we must act legislatively. This committee doesnt have the same jurisdiction as the Judiciary Committee but it does the finance committee does have jurisdiction over healthcare and Economic Security and there is a lot we can do to examine a whole range ofce issues under those pride topics related to communicate on communities of color and to help these communities or actions must focus on those actions and second i would note in the broad category of covid19 the death resulted in the number of cases the death number is disproportionately higher for africanamericans and in some states it is more than double or triple the percent of the populationon the percent of the deaths are outpacing by a long shot. As it relates to what this committee could be doing in connection to covid19 monday areas senator brown mentioned we should have the hearing to focus on a couple of topics first and foremost we should hear from the senate Medicare Medicaid services to ask them questions about transparency and information and data about cases in Nursing Homes and deaths to the extent that i end senator wyden and a number of colleagues we have had 40000 deaths in Nursing Homes. 40000 plus including residents and workers. There has been a failure to collect data. They need funding, they need testing, ppe come i have a bill to do all off that senate bill 3768 the only been on the senate to provide that help. 20billion where they separate the residents from those who have covid19 and those that dont and surge teams and other best practices to get the professional help needed when a nursing home is. In crisis. But with your leadership in this hearing at least you have a hearing related to covid199 unlike the floor on the entire month of may all nominations without limited exceptions of a few in the service intelligence. Senator warner. Thank you mr. Chairman i went to talk to the panel and our friends in the fda about supply chain issues that this virus has exposed. It seems to me our stockpile is significantly underprepared for this virus so what kind of partnerships have the fda looked at with outreach to the dod partners as a vice chair of the Intelligence Committee on how we would be better prepared in terms of a stockpile to support the partnerships which of the colleagues will address that . I can start and maybe the others would chime in. I can tell you about the interagency partnerships we have formed. I agree they are critical we had then engage with discussions with fema since day number one in response to the covariate outbreak and distribution to help the make good decisions and with a Strategic National stockpile to focus through hhs and also to be engaged on a daily basis because we understand the need for us to support on provide whatever support we could about the Strategic National stockpile and to be in close contact with the dea t with controlled substances and the need for controlled substances and opioids for pain and ventilators and to do everything we can to support that work regarding the availability of those products and then finally the Acquisitions Group is engaged with us and other rmanufacturers have taken up. I need to interrupt. I dont have much time. One of the things we have discovered as the administration had state versus state searching for ppe and equipment coming from those sources and china in particular, in terms of thi this, have you had any outreach to the Intel Community how we better prepare . Theres a lot of us on both sides of the aisle that dont want to be reliant on china for api Going Forward and circumstances not having domestic supply on hand ppe talkingg mostly domestic agencie agencies. I have not been a part of those conversations that doesnt mean they have not occurred i would be happy to get back with whatever information that we ca can. Colleagues . Do you have any questions about those facilities in the second panel they could highlight some of the work from the Virginia Commonwealth University in this space but im really concerned about the domestic sourcing. And we are ongoing looking at not only the National Strategic stockpile to get into the Intel Community because they are key to understand those supplies are there and a robust body of work where they are coming from and countermeasures and the whole shebang we will continue to report out as well as those reports over the longer period of time. I do hope having that resilience of the supply chain to recognize resource this material and from a National Security standpoint mr. Chairman i do know that i think it is a National Security issue that needs serious attention hope to come back to we visit i yield back. Senator white house . Im here. Go ahead. Thank you mr. Chair and Ranking Member wyden to our participants and the witnesses were participating today. I want to start off talking about the murder of george floyd was at a time many africanamericans already feel despair about the way thisai pandemic is disproportionately taken their lives and livelihood we could be working on actions for adjusting rifle concerns. But we are having this hearing today and i want to focus on the fact that in the last few months fda has authorize the use of hydroxychloroquine without the evaluating the Safety Effectiveness to allow highly inaccurate tests to into the market. They havese negatively impacted this pandemic to put lives at risk it we do not have the fda official here today to speak to thoseto decisions and with that oversight for the federal sesponse including the examination of what has happened in our countrys Nursing Homes like many other states Nursing Homes have been devastated and the death and New Hampshire is unbelievably disproportionate in the longterm care facilities some a couple of questions. Your testimony before the House Energy Commerce committee, can you discuss the risks for those that relied moand can modify its approach to exacerbate that ris risk . The gao has reported while fda has many tools to be critical with those offices specifically to have boots on the ground to be a bad actor so i understand that i need to protect their own people and we want to ensure the other stuff they have in places rigorous. Thank you for that clear response i want to understand need that your work is essential given that safety and then to curtail expections is an appropriate and i would thank you have concerns about it to. We do have concerns. Doctors, to have the opportunity to travel to china last year speaking with officials o brown the massive production of fentanyl 90 percent originates in china and is unregulated. Continuing to push efforts to put a stop to ill legal production to people in New Hampshireir and beyond can you speakte to the steps the fda is combat from china im interested to hear the growth your agency is in china and those who crossing the border including sales on the darkon web. Our enforcement efforts are focused on the International Mail facilities and in addition the office of criminal investigations and the staff investigates those including fentanyl we are working primarily on counterfeits in conjunction with other lawenforcement counterparts. Fiscal year 19, we had 55 arrest and 53 convictions related to these products. So we continue to work hard and help against fraud surrounding this product. And i have a lot to add to that im glad you make that distinction with that illicit drug use from prescriptions that is happening within us borders but there is some confusion there. But in regards to the manufacturer we have been focusing on the borders working for people and then from other sources. Thank you mr. Chair i dont want to lose sight of the fact that we can that with the opioid have one epidemic. Is senator white house available . Senator cassidy . Senator cassidy is here. Go ahead sorry i am not on video. Doctor, this is fda talking about api coming from china it was pointed out there doesnt seem to be that much of a shortage but that is different than the chemical that goes it. In and the understanding that percentage of the chemicals used are from china. Is that correct . I am not familiar with that data. We know substantially about the sources of those o products then we do about api and was mentioned earlier but the manufacturing and distribution. He is involved with trade. Are you familiar those that come from china . I am not familiar with that data i can look back at it and get back to you. That seems to be theth critical thing because api is onee step but the chemicals are another. So that actually seems to be your point of vulnerability unless we have a stockpile. For example, the High Percentage of production in china and what would be the reason for that . Is it access it doesnt sound like you are familiar with this but get back to us regarding that. But gao makes a point even in innormal times its tough to get a site into chinese manufacturing. So just to say its important to consider the strategic api bureau reserve. With brazil and mexico both a presence pharmaceuticals its better to have them manufactured in brazil than china for a variety of reasons. Can you give us a sense of challenges and how the foreign drug inspection process going there . Is that an alternative for us . Why we cannot do inspecs they normally would in a foreign country in termsms of the jurisdiction, therefore we have to notify them. Theres two things about that. It was suggested when we were doing this in 2015, there was a bias but how these companies were selected and it made it the result that we were doing spot inspections. Second, they have the ability to say your goods are not coming to the United States. And so, give me a sense of why your jurisdictional issue is different than what he said, and also why is it or else we are not within your products come over . Thank you. You are correct. If we go to inspect a foreign facility and they refused our inspection, we do have the authority to get those products from entering the u. S. Commerce. To let folks know, we do conduct unannounced inspections. Generally they are on a four their reason it is identified such as an informant or there is a trade complaint that we will go in and conduct. We have and we do conduct unannounced inspections in the foreign space. And again, if they deny an inspection, we do have authority to place the facility along with the products on a import alert how many unannounced inspectioninspections did they n manufacturing plants in china and india last year . Predominantly, they were announced. I dont have the exact figures. Remember that we doar not have we are just implementing in the it system to actually have the capability to record whether the inspection has been announced or unannounced. So, once we have the data, we may be able to identify with the outcomes of those inspections are. Im a little bit surprised that you do not have a list of how many. But i would yield back in the interest of time. Thank you. Thank you, mr. Chairman and thanks to the witnesses for being here today. For the safety and quality of the nations supply and Prescription Drug supply is the key priority to respond to the corona virus pandemic. The issue for Prescription Drugs and ppe has been brought to the forefront so i appreciate the discussion today. The as we continue the discussions on the corona virus response efforts, what updates can be fda provide with respect to provisions in the act aims to address the supply chain issues namely requirements for the Greater Transparency regarding supplychain disruptions . Thank you, senator. I appreciate that question. In general, we are very grateful to the provisions in the legislation. We are in the process ofe implementing. We anticipate that we are going to be able to make use of the legislative authority that we are being granted and expand the amount that weho get. Information is power in this setting and as we discussed throughout the hearing, the more we know about the product is moving in the manufacturing chain, the better we can do as far as preventing shortages. So, this is a very important piece for us to and thats what we were able to make do with it. But in the expectation that it is going to be helpful. Ak are you aware of that provision in the act . Im, but i do not have any further information. Just as a followup to the line of questions come and im sure much of this ground has been covered already. The perception has been through the pandemic there have been shortages or disruptions in the supplychain, particularly with regards to pharmaceuticals and ppe as it relates to those that are manufactured and particularly china, but other places around the world. So, i am wondering if you all could comment about the accuracy of those reports and whether or not the concerns people have about the future with those of supply chains are valid and whether or not we ought to be providing incentives to bring many of the capabilities back here to stand up those capabilities in the United States. How reliable are these supply chains when the manufacturers that are operating currently are in Foreign Countries . First, without any question, covid is an unprecedented account on the supplychain with regards to the growth shortages. One that we have been looking to confront for several years. Superimposed on that were unprecedented need for medicines, and its required that the fda change the approaches to identify and respond quickly to those shortages when they occur, agwhether it is in the hospitals and the new york state area or some other area. Weve had to adapt procedures to put in ways to respond quickly within hours wherevers we ca who find new sources of products for the population, whether it is in a state or even in the smaller locality. Going forward, you are also correct that weve got to think about the next challenge so covid will not be the last time we are asked to respond in a National Emergency or one this size. We need to find ways to strengthen the supplychain and find ways to incentivize the supplychain that is robust and reliable. And to bring things into the u. S. Is one way to address that. We are firmly supportive of things like advanced manufacturing, because we think the u. S. Has an advantage in heose areas that could help steer helping all of us both with regards to security, availability and quality for the medicines we need now and medicines we are likely going to need for the next emergency. Mr. Chairman, my time has expired. The next person is senator gains. If he doesnt speak up, i will call on senator young. If senator young doesnt speak up i will call on senator crapo. The next one, senator cortez. Thank you, mr. Chairman. Thank you everyone for the conversation today. Let me say this [inaudible] i would ask the chair consider having a further oversight hearing as it pertains to to the data [inaudible] i would put that in an echo of a request of some of my colleagues as well. Let me start with mr. Abdu. As we look to the development of the covid19 vaccine, how does the agency expects to h balance the scale of production quickly with the need for the oversight [inaudible] thank you, senator, for the question. As you know, vaccines are regulated through the center for biologic evaluation and research and our experts there would be the best situated to get you thatt information. Im happy to bring the question back to them. Thank you. I appreciate that and i think that is going to be very helpful for us in the future. Let me ask you this. I appreciate senator cassidys line of questioning, because i do have questions from the gao report about this unannounced inspection and announced inspection. N whatever information you prove for the followup, you need to provide it to my office. It was reported that most of the unannounced inspections, when we talk about these unannounced, it isun giving them what, 12 weeksr more you will be presenting to the facility so they had enough time to prepare knowing that an inspection is going to occur, is that correct . Thank you for the question. Its not a matter of having them enough time to prepare. Its having enough time for us to prepare to make sure that we have the reasons available and our staff have actually been able to take the state Department Clearance training. It requires more time to plan and investigators must complete the necessary documentation for obtaining official passports, visas and required state department training. Any delays i delays and this can jeopardy or lastminute change in travel. By getting them advance notice that you are coming comment you have concern that they are going to take action in regards to that, and what kind of action would be taken . Again, remember the firms, foreign firms and the Domestic Firms are inspected the exact same way using the same standard and requirements whether they are domestic or foreign commerce of the expectation is for the firms to be able to have quality products developed at any time during the process. What is yourr distinction . To me, unannounced is you have concerns that something is going on and you do not want him to correct it while you are there inspecting and then go back to that. Am i missing something here . The firms have the responsibility to help the process in place that they can develop quality products. The inspection is one aspect. Its a moment in time. So, they haveve to have the Quality Systemsms in place throughout the lifecycle of their product. It isnt just while we are there. While we are there we are looking at the Quality Systems, but its up to the individual facilities and manufacturers to have a role and ownership in providing quality products. Why have an unannounced inspection . Think of it if we are going to do a preapproval inspection, for something that is tied to an application its important that we do give notice on those preapproval inspections, because we want to make sure that they have the Data Available, that we have the people to talk to at the firms that can talk to the types of manufacturing people so we can talk with them to see how they are prepared to manufacture the product that is associated with the application. So thats what we do a preapproval inspection. So we do announce. Then we do announce when we we will not announce if we have concerns that there might be, youu know, issues that have been brought to our attention from manufacturing. If thereve been patients complains or consumer complaints or manufacturing, we would want to go in their unannounced. And why would you want to go unannounced . Sometimes just to not give them any specific insight primarily. Because you have concerns they might do something in response knowing that you are coming . There may be some. What weve seen from the outcomes is that in general, there isnt a huge difference nwhen we have an announced inspection or wewe dont. If we look at our official action indicated where there has been violations from a domestic standpoint, that is not about 7 for medical drug products. Verses in the foreign arena, it is more about 10 . I noticed my time is up. It looks like ive gone over. I appreciate the indulgence. I have other questions for the record. Thank you very much. I guess i will wrap up here with the first panel. I want to thank you for coming to the committee today. We find your perspective and expertise on this very important topic. Chinas coverup and response to the corona virus outbreaks at the world behind and caused this to rage across the globe and devastate economies and Public Health. The Chinese Communist partys reckless actions to downplay and lie about the severity of this has changed the lives of every american. People across the state are losing their jobs. Businesses are closing their doorswo. Working moms and dads are struggling to put food on the table. As more information comeso to light, we must hold china accountable to ensure that this never happens again. Its long overdue we and the reliance on china to produce the medical supply equipment as well as lifesaving drugs. Over 70 of the personal protective equipment coming in,r one third of our antibiotics are imported from china. Being dependent on china as a threat to our health and National Security. Be safer in america will be stronger when we bring our pharmaceutical and ethical manufacturing supply chains and those jobs back to america. Commissioner abdoo, there is substantial concerns that chinas pharmaceutical industry is not effectively regulated by the government. Chinas regulatory apparatus is inadequately resourced to oversee thousands of chinese george manufacturers come even if beijing made such oversight a greaterif priority. This is the result of significant drug safety scandals. What are the most challenging aspects of maintaining Quality Control of chinese pharmaceutical imports into the United States . Thank you for the question, senator. I will start off and turned to y colleagues. Through our office in beijing, we worked extensively with the National Medical Products Administration in china to raise thein standard of their abilityo regulate products within their jurisdiction. We do this by promoting harmony with International Standards and by promoting membership like the eupharmaceutical inspection cooperative that helps create standards for inspections, and we do this also in addition to work with educating industries about requirements for the fda so that they can better comply and improve the quality of the product tha but they are exportg to the United States. With regard to what we do here domestically in terms of importation and so forth, im going to turn over to doctor mcmeekin. So, as mr. Abdoo mentioned, the fda jurisdiction of a foreign firms product begins iswhen the products arrive at te borders and attempt to enter into interstate commerce. Fda uses additional tools to help complement those inspections. And this includes utilizing our import screening tools called predict, and we have and adjusted accordingly. We also conduct physical examinations and or product testing at the borders to make sure that as products come in. We are also requesting records from facilities. So we can request records. We have received authority to request these in advance so that inspections are in lieu of this and we are looking at batch records and program data to be able to see if theyra are complying. Thank you. Hispanics are you are not actually auditing the process, you are looking at documentation without having physical presence on their site. During this pandemic. I have a followup question back to the commissioner. One of the biggest impediments to the truck manufacturing in america, what would be the benefit of having the supply chain for the most critical s drugs . I think doctor throckmorton might be in a better position to talk about the manufacturing in the United States. Thank you, senator. When wee talked before about this, we identified a few factors. One obviously is labor cost. Another relates to the environmental regulations and so far there are very different standards in that regard. Third is the economics of drug manufacturing. In the report that we predicted last fall we believe that there is fundamental disconnect in the incentives to create highquality and reinforcement for the products that are of high quality. We think we can change that if additionalovide transparency identifying products that are very high quality so they could potentially choose the products that barely meetat the mark. I am out of time as well. So, this will conclude. Thank you to the witnesses for answering the questions and we are now ready to see panel number two. Thank you. We will get started with the second panel. Id like to start with introductions first ofl all, david white, biotech entrepreneur and scientist with over ten years in the field. Hes the founder and ceo. They test drugs for carcinogens before dispensing to patients. David helped found, fund and indent the Quartet College he and his named inventor on numerous patents. Our second member of the paneler today is martin, president and ceo of the nonprofit, nonstop corporation founded in 2018 and is part of a new u. S. Government funded partnership to produce essential Generic Medicines and u. S. Ients in the the priority for the partnership will be the covid19 response. To the over 50 Healthcare Systems are representing more than 12 u. S. Hospitals in over 30 of all hospital beds. Since we dont have time restraints, each witness has five minutes for their Opening Statements, and we will begin with mr. Life. Thank you for the honor of being able to speak before you today. I am the founder and ceo where our mission is to help ensure the safety, quality and transparency of medications. With a very simple and novel approach. The only pharmacy that checks the chemistry of every batch of every medication with no additional cost to patients. This is particularly important given the nations reliance on overseas manufacturing and putting additional strains on an already stressful system. We reject over 10 of the medication batches that we tested due to a variety of product defects. The pharmaceutical supply chain is complex and heavily reliant on the selfregulation of overseas manufacturing. Theyve traveled over hundreds of thousands. No one is satisfied to know that the original manufacturer sold its good. D. You want a carfax report and to see a 100 inspection, none of that transparency is available for the medication. We strongly believe more can and must be done. The idea of checking drugs may be new to the industry, but not the academic world. N wever, warnings fromng academs have been largely ignored. A grim example of this is the drug zantac. In 1977 1977, senator senators s very building andnd listened to testimony that certain drugs are unstable and form potent carcinogens. Similar concerns were raised a year later at a summit held by the World Health Organization and the united nations. The zantac has the exact chemical structure of the Scientific Community warned about. And yet the drug was approved only a few years later. In the following decade, dozens of studies implicated zantac is chemically unstable and prone to forming. But the papers had zero impact. By the 1990s, zantac had become the number one topselling drug and, my prescribed to treat acid reflux and pregnant women and infants. S it wasnt until 2019, 36 years after the drugs approval that they performed a simple action of independently checking generic syrup prescribed to the cofounders and didnt bother. The results were so dramatically immediately took the drug off the formulary that we were not satisfied by simply publishing the findings in the journal. We didnt back down from the crystalclear science but its unstable and should be taken off the market. Two months ago after the countries that already banned the dangerous drug the fda finally granted the petition and it was officially taken off the u. S. Market. Without independent testing and the drive to make it broadly transparent, zantac would have remained on the market for many more decades to come. The value of independent testing doesnt have to be limited to just do this pharmacy. I believe there are two clear paths throughout the u. S. Boiled down into those that could be as simple as a red yellow green rating that provides transparency to any drug purchaser. They can use this guidance to buy green, yellow and avoid red. What they call certified drugs. By employing independent batch testing a manufacturer level, we can read out the quality batches and bring certified medications to the millions of americans regardless of which pharmacy they go to. This is entirely reasonable to do for the drugs. The top diabetes drug and fourth most Prescription Medication in the u. S. With over 80 million prescriptions a year. Theyve published two studies showing approximately 40 are contaminated with a carcinogen above acceptable limits. This means billions are taking the drug every day that contain a carcinogen that absolutely should not be there. In summary, we have very Serious Problems in theug drug supply chain that are caused by the complex factors all of which are made worse by covid. Above all, independent, semantic analysis cannot continue to be ignored and must be part of a new how forward. Thank you and i will yield back to the question. Thank you, chairman grassley, Ranking Member and members of the committee. Im the ceo and i am honored to be here and follow a group of dedicated Public Servants. They are a nonprofit 501 c 4 to reduce drug shortages in the United States. We serve patients by making quality medications that are lyways available and affordable. More than 1200 u. S. Hospitals and 50 u. S. Health systems have joined. We also supply the veterans administration, the department of defense as well as the eligible hospitals. R many of our drugs are used in the management of covid and we have been able to supply them without fail. We even contributed 1. 6 million files of dedication for the Strategic National stockpile. Several features of this model they offer insight into the broad supply chain. We rely on the longterm contracts to provide a certainty for us to invest in Quality Systems capacity and staff. We have backed u back that the o create redundancy and we maintain six months of safety stock. We prefer to buy american where possible and then from other highly regulated economies and avoiding chinese ingredients as much as possible. Finally, we select medicines to make based on the needs identified by pharmacists and physicians on the front line. To further support the resilient supply chain, civica recently entered a partnership in the federal government to make essential drugs here in the United States. This agreement will result in an end to end u. S. Manufacturing supply chain for essential drugs which will result if the nonprofit pricing. As Congress Considers other measures to improve the supply chain, we urge you to keep these principles in mind. To focus on a set of essential drugs. Raising issues whether or not this committee with this hearing or anything else that we have done since the pandemic it whether or not we have been putting our attention in the proper direction and obviously a lot of my democratic colleagues. Eel otherwise so it appears the number of democratic colleagues who have commented today and may be some who did not because of the usual courtesy that goes on in this committee whether the colleagues that commented or not you have been out of touch with what the committee has been doing recently based on comments and to mention in a previous response to senator brown the billions of dollars this committee was involved in while responding to the coalbed crisis and the economic turmoil that has resulted from it. I guess some of my colleagues think that somehow you just pass a bill and then you forget about it but the staff and some members have spent weeks to follow up and desist and implemented the 3 trilliondollar relief package that we passed. In addition i have heard other avg ion aco today. So these colleagues on other issues are not aware i have been working with the Ranking Member to have the Unemployment Insurance hearing next week. I also sent oversight letters regarding thedi nursing home homes, waiting on information before any potential hearing because you are to have your ducks lined up before you take all the work that goes into a hearing. If you want that hearing to be productive. It is bottom line like this i request before complaining in the future it would be helpful to talk to me or have your staff talk to the staff of this committee if you did that you have a better idea of what we are talking about and what we have been doing besides its already on the Public Record in regard to our response to the pandemic and the response to the economic turmoil caused by the shutting down of the economy and our government and it is opened ups i will start my questions t and to collaborate with hhs department of Affairs Center for Medicaid Services and working with the Trump Administration and biomedical andnced researchon authority avenue manufacturing plant and for the purpose of the plant is as i understand it to expand generic pharmaceutical manufacturing in the stockpiles and for Public Health agencies which i guess and turn would put us less dependent on china and other countries. Has the Trump Administration t been a good partner to the issues of generics in short supply . I started my testimony today by acknowledging the hard work and dedication of Public Servants and to protect the American People even before the pandemic it talking with officials with hhs to focus on security pharmaceutical supply chain. Because we have a direct relationship with physicians on the front line of the pandemic we have been able to provide information that helps lpthe priorities with those hageneric medications and also i have to add that since covid my faith in Public Servants has only gone up these individuals have worked 24 7 aroundtheclock to make sure they could do the best job possible to bring ppe medical devices and testing to the American Public who needs them the most. Based upon your experience had a congress assist in those Manufacturing Companies to return to the United States . Frequently from allied of organizations or individuals interested in starting their own nonprofit some are interested in drug shortages others drug prices and still others to have a market failure such as the need for new antibiotics that the traditional commercial model notforprofit pharma not as the alternative for the forprofit industry and there were several things to help this succeed and nonprofits cannot raise capital the same way that private sector does. And with those financial commitments and philanthropies but in some cases the government itself may want to look at the model is a solution to the problem using grantsan and low interest loans and other private mechanisms with the firm industry to blossomhe there is a great number of bills that have been introduced in congress recently some very bipartisan and then to have the pharmaceutical industry. And then to apply those efforts. And the last two or three questions so the Business Model includes testing drugs before dispensing to patients do provide the committee a couple of examples the Testing Process to make them more safe and effective . We test for a whole variety of components and dosage that dissolution rate that dissolves in one stomach or intestines and a variety of carcinogens and have been asked us on discussed extensively everything we have looked for some more than others and the carcinogens and just last week i recall on a new drug we test for a variety of these. My second question would be the relationship with fda do you report the contaminated drugs to the fda and what is their response . Because they are outside of the manufacturing system not a good manufacturing facility or a pharmacy that has a laboratory so the guidance we received from the fda is to report these findings to industry which have the freedom not to pay close attention given we are not a facility. I think it underscores the point that independent analysis from academics have been largely ignored we are not part of this regulatory bubble and then that the fda citizen petition so we have sufficient data end up in problems and then to make these recalls. How much does the process cost . And with that particular analysis we use that technologies with it with into no additional cost to patients this cost of independent analysis to actually dispense this to the patient at the pharmacy level and a larger levels manufacturers will be small. My last question is how do you see your system with drug manufacturing . Help to improve the system as a whole like zantac. And then to see this as an opportunity to what has been discussed a few times during this hearing with the quality manufacturers to advance and maturity on the science and evidencebased approach to actually infuse this independent analysis in addition to what the manufacturers already do. I want to thank the two witnesses right now that are still here and on the senate floor the first panelpa left so whether you are government or private sector and covid has created many logistical hurdles did i forget senator wyden . But i guess i have a couple of additional questions. I really apologize. Im sorry. I will wave my closing statement until you get done. I want to make a comment in some constructive ideas a reality. Your company as part of the contract with the Trump Administration recently awarded to t make covid19 drugs. Which drugs are you manufacturing right now . The intent of the grant that was given was not to be making drugs are api today but to put the infrastructure in place for p the next pandemic or crisis. However seneca already has a series of drugs we provide our members for use during the pandemic and those involved antibiotics, agents and medications and local anesthetics. We provided over one. 6 million vials at the request of the government for the stockpile to do that and we are prepared to provide more if asked. I just want to make sure we are clear. You got this g contract, and you said something about working on infrastructure for the future. Always useful. But im not clear on and what you are doing as it relates to covid19 drugs now. Have you given covid drugs to the government we dont know about . Yes. We provided over one. 6 million to supportugsmi Covid Patients of low spectrum antibiotics. That you were doing that before the covid19 pandemic, what you . We were not supplying the national stockpile. And defined by value added the government got for its money what drug contractor made it . And to make the api facility and the precursors as people talked about especially the precursor using brandnew technology and this contract has not been designed to set up manufacturing today but. Im always interested in the future but the urgency of communities like covid19 to get them help now and im still unclear. My time is short i have to make one last point. Is the chairman so there . So i just want to make a brief comment to my friend with respect to the afternoon. I have been here for three and a half hours want my colleagues and i have raised is not day question primarily of courtesy all that were reasonable and tolerant it is the urgency the Racial Injustice of American Healthcare is an immediate need the Africanamerican Community has been hit by covid19 like a wrecking ball. And on our side of the aisle to make sure the finance committee that has such enormous power and 2 trillion annually will use the extraordinary muscle to make sure the Africanamerican Community has been hit so hard and has been responding right now to injustices all across the community will see us use our influence to get those communities of color so raise this but i think its unfortunate nobodys on the other side of the aisle. On a positive note can we agree as i might ranking minority member with members on both sides to move very quickly to put together a hearing and the agenda that actual agenda to use the muscle of the committee of those Racial Injustices. We have been here three and half hours. Is that something we can take from this Going Forward with our staff and colleagues in the Racial Injustices that so many africanamericans are telling us about lederle hour after hour each day. Is this something we can agree on . We can discuss whatever you want to discuss as you sit down with me anytime i suggest we discuss things. The only thing i would ask you to take into consideration is we areevery program involved in with this committee whether Social Security going back to 19 or going back can tell Unemployment Compensation that has been around since the thirties are because we are all americans we have got to pull together and my goal is not to leave anybody behind. Mr. Chairman, if i might it is very clear that these Healthcare Programs are not colorblind we have seen study after study showing communities of color are disproportionately affected that what we are talking about the services for example dont even come to their communities so in the house legislation they did incredibly well. There werent so i will leave this and hope we can work it out quickly and respectfully that they are not colorblind it shows his question it affects the. One people of color and for that and to do that in constructive ways to get a hearing scheduled and an action plan to reverse those distractions. Is and all of those to discriminate against anybody. So once again for the second time thank you to the witnesses the private sector for attendance today. Covid has created many logistical hurdles to make todays hearings happen. I appreciate all that people have done to be a part of this very important discussion. In a addition i want to thank the clerk staff for their hard work and time and attention to make this hearing happen. Today we discussed many important issues that have existed for decades that because of the pandemic they are now more important than ever before the executive branch takes all necessary steps to properly oversee drug supply chain and we must Work Together to ensure safe and effective drugs and with that drug supply chain and also aggressive and unannounced inspections provide the best way to catch those bad actors and i expect hhs in the subcomponents and engaging in inspections so to highlight one aspect of drug supply chain it ends in the United States Going Forward to entertain serious policy discussions to bring manufacturing back to the United States and in the coming weeks ill be working on the next focus of ppe supply chain with that the hearing is over members have one week to provide questions i hope you will respond appropriately. Meeting adjourned. Meeting adjourned. [inaudible conversations]