11 May 2017 Senate HELP Committee’s Passage of Bipartisan FDA Reauthorization Important Milestone for Patients in Health
Washington, D.C. – BPC Action today released the following statement on today’s Senate Health, Education, Labor, and Pensions (HELP) Committee’s approval of the Food and Drug Administration (FDA) Reauthorization Act of 2017:
“Today’s Senate HELP Committee passage of FDA legislation by a vote of 21-2 represents a good model for bipartisanship, and an encouraging milestone for patients.
“This legislation reauthorizes pharmaceutical, medical device, generic and biosimilar drug user fee agreements, giving the FDA new tools and support to efficiently approve safe and effective treatments and cures for patients. These build upon and support goals in the 21st Century Cures Act enacted with broad support in 2016.
“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.
“These goals align with Bipartisan Policy Center recommendations in: Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the United States and Advancing Medical Innovation for a Healthier America.
“We encourage continued bipartisan collaboration and support for these important goals as the legislation advances to the Senate Floor, and as the House Energy and Commerce Committee moves to consideration of its version of the legislation.
