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Key Considerations for the Food and Drug Administration’s User Fee Reauthorization Bill


Since the passage of the bipartisan 21st Century Cures Act in December 2016, tremendous progress has been made to accelerate bringing safe and effective treatments and cures to patients. The legislation included several provisions that will improve the discovery, development, and delivery of medical products for millions of Americans and improve U.S. global competitiveness.

Congress is now poised to advance biomedical innovation in the United States through “must-pass” legislation reauthorizing FDA user fees for prescription drugs, devices, and biosimilars. These fees make up a significant part of the agency’s budget. The deadline for reauthorizing these agreements with industry is September 30, 2017.

On April 14, 2017, leaders of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee released a draft of the Food and Drug Administration Reauthorization Act of 2017. Timely completion and passage of this legislation before Congress adjoins for its August recess is a crucial next step toward helping Americans in need of medical treatments and realizing the promise of the 21st Century Cures Act.

Timely completion and passage of FDA user fee reauthorization legislation is a crucial next step toward helping Americans in need.

BPC’s report, Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the United States, provides insights and recommendations to inform Congress as it finalizes and passes user fee reauthorization legislation in the coming weeks. The recommendations draw from BPC’s work over the last several months and developed through BPC’s Advancing Medical Innovation effort under the guidance of former Senate Majority Leader Bill Frist, MD and former Rep. Bart Gordon.

The draft legislation implements several important provisions, including increasing scientific expertise and capacity at the FDA, accelerating the use of real-world evidence and other drug development tools to improve regulatory decision-making, incorporating the patient voice into the medical product development process, and improving the review of combination products. Such provisions align with BPC’s previous recommendations in Advancing Medical Innovation for a Healthier America. as well as the 21st Century Cures Act.

Other BPC recommendations should be considered through separate legislation, including those related to clarifying and increasing the sharing of scientific information with clinicians to support off-label use of approved medical products, clarifying regulatory authority associated with laboratory-developed tests, and supporting implementation of a national registry for regenerative cell therapies.

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