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 manu