12 Jul 2017 BPC Action Applauds House Passage of Bipartisan FDA Reauthorization Act, Calls on Senate to Act in Health
Washington, D.C. – The House of Representatives’ passage of the Food and Drug Administration (FDA) Reauthorization Act of 2017 today represents a significant step forward in improving the development and delivery of safe and effective cures and treatments for Americans.
Legislative provisions align with and support the implementation of the bipartisan 21st Century Cures Act, as well as the Bipartisan Policy Center’s recommendations contained in several reports, including Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the U.S.: Key Considerations for the FDA User Fees Reauthorization.
Janet Marchibroda, BPC director of health innovation, said of the bill:
“In addition to providing industry user fees that support a significant part of the FDA’s operating budget, the FDA Reauthorization Act will increase scientific expertise and capacity at the FDA, bring the patient voice to the medical product development process, and both modernize and improve regulatory decision-making through expanded use of real-world evidence, adaptive trial designs, and drug development tools.
Failure to pass the FDA Reauthorization Act before current user fee agreements expire in September would result in lay-offs at the FDA and delay implementation of many of the important provisions contained in the 21st Century Cures Act.”
BPC Action commends the House’s swift passage of the FDA Reauthorization Act and urges the U.S. Senate to act before the August recess to assure that the resources are in place to continue to carry out critical activities that will accelerate the availability of safe and effective cures and treatments for patients.