FDA User Fee Hearing Scheduled for Thursday

The House Energy and Commerce Health Subcommittee announced a forthcoming hearing on the reauthorization of the Food and Drug Administration (FDA) User Fee programs scheduled for March 2. The hearing will focus on both the generic drug and biosimilar user fee programs. The programs expire in September 2017, and must be reauthorized for fiscal years (FY) 2018-2022. Approximately half of the FDA’s annual budget is funded through user fees paid by drug and device manufacturers. The programs were enacted to reduce the backlog of applications pending at the FDA, and legislators will hear about how the programs have been implemented to date. During the hearing, the subcommittee will also consider H.R. 749, the Lower Drug Costs Through Competition Act. This bipartisan legislation aims to increase competition and lower prices in the pharmaceutical industry. It encourages the development of generic medications in the case of shortages or absence of competition, particularly among high-priced drugs that have lost patent protection.

Upcoming Congressional Hearings/Meetings

House Veterans’ Affairs Oversight and Investigations Subcommittee hearing on “Assessing VA’s Risks for Drug Diversion;” 3:30 p.m., 334 Cannon Bldg.; February 27

House Judiciary Committee markup of H.R.372, the “Competitive Health Insurance Reform Act of 2017”; H.R.1215, the “Protecting Access to Care Act of 2017”; and H.Res.111, Resolution of inquiry directing the attorney general to transmit certain documents to the House of Representatives relating to the financial practices of the president; 10:00 a.m., 2141 Rayburn Bldg.; February 28

House Homeland Security Emergency Preparedness, Response and Communications Subcommittee hearing on “The Future of FEMA: Recommendations of Former Administrators;” 2:00 p.m., CVC-210, U.S. Capitol; February 28

House Science, Space and Technology Committee markup of the “NIST Cybersecurity Framework, Assessment, and Auditing Act of 2017;” 10:00 a.m., 2318 Rayburn Bldg.; March 1

House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee hearing on “Member’s Day;” 10:00 a.m., 2358-B Rayburn Bldg.; March 1

House Education and the Workforce Committee hearing on “Legislative Proposals to Improve Health Care Coverage and Provide Lower Costs for Families,” including H.R.1101, the “Small Business Health Fairness Act”; the “Self-Insurance Protection Act”; and the “Preserving Employee Wellness Programs Act;” 10:00 a.m., 2175 Rayburn Bldg.; March 1

House Energy and Commerce Health Subcommittee hearing on “Examining FDA’s Generic Drug and Biosimilar User Fee Programs;” 10:00 a.m., 2123 Rayburn Bldg.; March 2

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