Washington, D.C.– Provisions in draft legislation reauthorizing the Food and Drug Administration’s (FDA) user fee programs will play a critical role in accelerating the development and delivery of safe and effective treatments and cures to patients. That’s the message of a new Bipartisan Policy Center report released today to help inform Congress as they consider updating and reauthorizing fee agreements the FDA collects from industry for prescription drugs, medical devices, and biosimilars. The fees make up a significant part of the agency’s budget and are set to expire on September 30, 2017, risking staff layoffs and timely approvals of new treatments and cures.
Recommendations in BPC’s new report, Accelerating the Development and Delivery of Safe and Effective Cures for Patients in the United States, were developed through its Advancing Medical Innovation effort under the guidance of former Senate Majority Leader Bill Frist, M.D., and former Rep. Bart Gordon. Proposals include 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’s voice into the medical product development process, and improving the review of combination products.
On April 14, 2017, leaders of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee released a discussion draft of the Food and Drug Administration Reauthorization Act of 2017. The bill contains provisions that align with BPC’s recommendations in its current report and its 2015 report, Advancing Medical Innovation for a Healthier America and the 21st Century Cures Act passed in December 2016.
User fees play a critical role in providing the FDA the resources it needs to maintain the gold standard in both the review and approval of drugs.
“The draft user fee legislation builds upon and is crucial to the implementation of the 21st Century Cures Act,” said former Senate Majority Leader Bill Frist, M.D. “We look forward to swift and timely passage to accelerate the development and delivery of safe and effective medical products for millions of Americans.”
“User fees play a critical role in providing the FDA the resources it needs to maintain the gold standard in both the review and approval of drugs and devices in the United States,” said Rep. Bart Gordon. “They also support our nation’s ability to compete effectively in the global marketplace.”
“Legislation that provides flexibility and improves both hiring and retention will enhance the FDA’s ability to tackle rapidly increasing complexity in both science and technology,” said Andrew von Eschenbach, former FDA commissioner and senior advisor to BPC. “The discussion draft also implements provisions that will modernize the science of evidence generation, including those related to biomarkers, real-world evidence, and adaptive trial designs.”
The new report also encourages policymakers to consider other BPC recommendations this year, 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.
“BPC was pleased to participate in numerous patient stakeholder meetings convened by the FDA to inform the development of the user fee agreements,” said Janet Marchibroda, BPC’s director of health innovation. “This legislation is a critical next step toward improving the FDA’s ability to deliver safe and effective cures and treatments to patients who need them most.”