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Senate HELP Committee’s Passage of Bipartisan FDA Reauthorization Important Milestone for Patients

Thursday, May 11, 2017

Washington, D.C.– The Bipartisan Policy Center applauds the Senate Health, Education, Labor, and Pensions (HELP) Committee for passing the Food and Drug Administration (FDA) Reauthorization Act of 2017. This bipartisan legislation reauthorizes important industry user fees, which make up a significant part of the FDA’s budget for prescription drugs, devices, and biosimilars over the next five years.

The legislation contains several important provisions that will improve the development and delivery of medical products for patients. It also helps realize the goals of the 21st Century Cures Act, which was passed in December 2016 with nearly unanimous, bipartisan support.

Provisions would:

  • Increase scientific expertise and capacity at the FDA;
  • Accelerate the use of real-world evidence to inform and improve regulatory decision-making;
  • Incorporate the patient voice into the medical product development process;
  • Enhance the use of drug development tools—such as biomarkers;
  • Advance the development of combination products; and
  • Facilitate harmonization of international standards.

Bringing real-world data—and the patient’s voice—to the regulatory decision-making process, will modernize drug development and evaluation processes.

These goals align with BPC’s recommendations for the FDA user fee agreements in its 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.

“This bill is a big win for patients,” said Janet Marchibroda, BPC’s director of health innovation. “Bringing real-world data—and the patient’s voice—to the regulatory decision-making process, will modernize drug development and evaluation processes. It will also improve evidence-based medicine, and enable better insights on both benefits and risks of drugs and devices.”

KEYWORDS: 21ST CENTURY CURES, FOOD AND DRUG ADMINISTRATION, JANET MARCHIBRODA, SENATE HELP COMMITTEE