08 Jun House Energy and Commerce Committee’s Unanimous Action Paves the Way for Swift Passage of FDA Reauthorization Act in Health, Report

Washington, D.C.– BPC Action commends the House Energy and Commerce Committee for advancing the Food and Drug Administration (FDA) Reauthorization Act (FDARA). Following the Senate Health, Education, Labor, and Pension Committee’s action last month this unanimous vote sets the stage for swift passage of the bill.

The legislation reauthorizes FDA user fee programs for prescription and generic drugs, biosimilars and medical devices, which otherwise would expire at the end of September. Importantly, the legislation will also increase scientific expertise and capacity at the FDA, accelerate the use of real-world evidence to inform and improve regulatory decision-making, and incorporate the patient voice into the medical product development process.

These goals align with commitments negotiated between the FDA and industry representatives, with a thorough and open process for public input. They also align with recommendations by the Bipartisan Policy Center contained in the April 2017 report, Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the United States, as well as BPC’s initial recommendations contained in the report, Advancing Medical Innovation for a Healthier America.

Following unanimous approval by House and Senate committees, Congress should act swiftly to pass FDARA before current user fee agreements expire in September, and if possible before adjourning for August recess. This will be critical not only for providing certainty for the agency, but also for supporting the goals of the 21st Century Cures Act to accelerate the development and delivery of safe and effective treatments for patients.