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Response of Stephen W. Schondelmeyer, Pharmd

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Response of Stephen W. Schondelmeyer, Pharmd Response of Stephen W. Schondelmeyer, PharmD, PhD Co-Principal Investigator, Resilient Drug Supply Project, University of Minnesota to Post-Hearing Questions for the Record From Chairman Gary C. Peters COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps Wednesday, May 19, 2021 Thank you Chairman Peters for submitting Post-Hearing Questions for the Record. The responses to your three questions are provided below. 1. How would you assess the federal government’s ability to coordinate and manage increasing drug supply shortages leading up to and during the initial pandemic response? The federal government has authority1 to collect many types of information to assist in coordinating and managing the emergence and mitigation of drug shortages. Among the information that the FDA can request and collect are: (1) details about the process for manufacture of drug products and devices; (2) a list of the active and inactive ingredients used in the manufacturing process of a given drug product or device; (3) the registration of facilities (both domestic and foreign) where such drug products and devices are manufactured, prepared, propagated, compounded, processed, packaged, labeled, repackaged or relabeled; and (4) a list of specific drug or device products processed at each registered facility. The federal government assigns a unique identification number for each drug product or device and for each registered facility. The information itemized above should have provided the federal government with the ability to build a comprehensive upstream supply chain map for drug products and devices sold in the U.S. market. However, for the information listed above, it is not clear: (1) if all of the information is actually collected by FDA; (2) how the various types of collected information are stored and accessed; (3) the extent to which the information is, or can be, integrated internally or with other data; and (4) if the information can be used to assess the overall market capacity and vulnerabilities in drug supply chains or the actual quantities of product available in the U.S. market. The FDA points out that it lacks information that would be needed to assess if, and how quickly, “U.S.-based manufacturers [can] increase their production of APIs [or finished dose forms] to meet domestic demand if China or India, or another country, ceased supplying the United States.”2 Furthermore, on October 30, 2019—just 2 or 3 months before the COVID-19 outbreak— the FDA testified before Congress that “we do not have information that would enable us to assess 1 21 U.S. Code §360 and other statutes and regulations. 2 Janet Woodcock, Safeguarding pharmaceutical supply chains in a global economy. Testimony of Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research, Before the House Committee on Energy and Commerce, Subcommittee on Health, Oct 30, 2019. 1 the resilience of the U.S. manufacturing base, should it be tested by China’s withdrawal from supplying the U.S. market.” 3 Among the other types of information needed regarding drug products, and which are not now readily available to the federal government, are: (1) the total and unused manufacturing capacity (both quantities and types of products) of U.S.-based and all registered foreign facilities; (2) the time required to produce additional quantities of needed drug products by U.S.-based and all registered foreign facilities; (3) comparison of quantities of drug products that can be produced by increased U.S.-based production versus increased quantities needed due to demand from a pandemic or decreased quantities resulting from a reduction in drug product supplied by China, India, or another country; and (4) how long would it take to increase, build, or re-shore the needed production and what other incentives would be needed to make such production sustainable for the pharmaceutical industry. The federal government needs authorization and appropriation to collect, coordinate and manage additional information to better facilitate the prediction, prevention, management, and mitigation of drug shortages. While the FDA has the authority to, and actually does, collect and use certain information related to the manufacture and marketing of drug products to manage drug shortages, the issue of drug shortages has continued to be a substantial problem in the United States. The FDA Drug Shortage Staff have been managing and coordinating the FDA’s drug shortage activities in recent years. In the past four years (2017 to 2020), the annual number of new drug shortages grew by 10.3% from 39 to 43 new drug shortages.4 Fortunately, during the same period (2017 to 2020), the annual number of FDA-prevented drug shortages increased by 37.2% from 145 to 199 prevented drug shortages. These results are to be commended. The net result, however, is that the annual number of ongoing drug shortages as reported by the FDA has more than doubled in the last four years with an increase of 109.8% from 41 to 86 ongoing drug shortages from 2017 to 2020. Both the absolute level of drug shortages (86) and the rate of growth (109.8%) in ongoing drug shortages are unacceptable results with respect to their impact on the health of U.S. patients. In order to minimize drug shortages, both before and during the pandemic, the federal government’s ability to coordinate and manage the increasing drug supply shortages required not only additional information, but also cooperation and the ability to share information across a number of federal agencies and with other stakeholders and academic researchers. Early in the emergence of the pandemic (mid-January 2020), several federal agencies began to meet and work together to anticipate and estimate the potential impact of the pandemic on the U.S. drug supply. Among the issues that arose with regard to coordination of drug shortage policy issues was: (1) which agency would take the lead in drug shortage policy and planning efforts; (2) what information did various government entities have to address drug shortage issues; (3) whether the federal agencies could share information across agencies or with appropriate stakeholders or 3 Woodcock, Testimony Before the House Committee on Energy and Commerce, Subcommittee on Health, Oct. 30, 2019. 4 U.S. FDA, Report to Congress, Drug Shortages for Calendar Year 2020. Accessed on July 3, 2021 at: https://www.fda.gov/media/150409/download. 2 academic researchers; and (4) how could information be securely shared and coordinated across federal agencies and with appropriate stakeholders and academic researchers. The Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (and the FDA) has authority to collect specific and detailed information regarding drug manufacture and marketing in order to ensure the quality and availability of drug products in the U.S. market. Among the data collected by FDA is information that could be used to anticipate, predict, monitor, and mitigate drug shortages in the market. A number of other federal agencies have information on drug use, demand, or purchasing including: (1) the Centers for Medicare and Medicaid Services (CMS) with data from the Medicaid and Medicare programs; (2) the Veterans Administration (VA) with data from the VA hospitals and clinics that serve America’s veterans; (3) the Department of Defense (DOD) with data from facilities serving America’s war fighters as well as their families and dependents; (4) the Department of Administration’s Federal Employee Health Benefit Program serving federal employees and their families and dependents; and (5) a number of other federal agencies. Other federal agencies have some insight and responsibility related to federal policy that can influence the market for drugs and related drug shortages issues, including, but not limited to: (1) the Federal Trade Commission; (2) the Department of Commerce; (3) the U.S. Trade Representative; (4) the DHHS Assistant Secretary for Preparedness and Response; (5) the Assistant Secretary of Defense for Health Affairs; (6) the National Security Advisor to the Secretary of Health & Human Services, (7) the Department of Homeland Security; (8) the Biomedical Advanced Research and Development Authority (BARDA); (9) the Federal Emergency Management Agency (FEMA); (10) the U.S. Department of the Treasury; (11) the Drug Enforcement Administration (DEA) within the U.S. Department of Justice; and (12) other federal agencies. The federal government needs explicit authorization to share drug manufacturing and drug shortage-related information across federal agencies and with appropriate stakeholders and academic researchers in order to facilitate timely management, coordination and planning for prediction, mitigation, and elimination of drug shortages in the United States. Senate bill 3781, known as the ‘‘Pharmaceutical Accountability, Responsibility, and Transparency Act’’ or the ‘‘PART Act’’, addresses both the authority for FDA to collect additional information related to the drug supply chain and drug shortages; and, it authorizes the sharing of information across federal agencies for the following purposes: (1) Maintaining the strategic national stockpile under section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b); (2) Evaluating health infrastructure under the Division of Critical Infrastructure Protection of the Office of the Assistant Secretary for Preparedness and Response; (3) Preparing for and responding to public health emergencies and
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