Washington, D.C.– With a nearly unanimous vote in the Senate today, Congress took an important step to bring safe and effective treatments and cures to patients by passing the Food and Drug Administration (FDA) Reauthorization Act of 2017.
The Bipartisan Policy Center applauds Congress for working together over the last several months to develop and pass this bipartisan legislation that will improve the development and delivery of drugs and devices for patients and support the implementation of the 21st Century Cures Act.
In addition to reauthorizing industry user fees—which make up a significant portion of the FDA’s budget over the next five years—the legislation contains important provisions that affect the lives of individuals across the United States.
- Increasing scientific expertise and capacity at the FDA;
- Accelerating the use of real-world evidence to inform and improve regulatory decision-making;
- Incorporating the patient voice into the medical product development process;
- Enhancing the use of drug development tools—such as biomarkers;
- Advancing the development of combination products; and
- Facilitating harmonization of international standards.
Provisions 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.
“The FDA Reauthorization Act plays a critical role in providing the resources needed to implement the groundbreaking 21st Century Cures Act,” said former Senate Majority Leader Bill Frist, MD, co-chair of BPC’s work on advancing medical innovation. “It is also a demonstration of how by working together, Congress can take big steps to improve the lives of the American people.”
“User fees will enable the FDA to both build capacity and expand its scientific expertise to tackle increasing complexity in both science and technology,” said former Rep. Bart Gordon, co-chair of BPC’s work on advancing medical innovation. “Not only is this good for patients, it also supports our nation’s ability to compete effectively in the global marketplace.”
“We’re delighted to see Congress act on this important bill before the August recess,” said Janet Marchibroda, BPC’s director of health innovation. “This legislation is a big win for patients. It will help bring real-world data and the patient’s voice to the regulatory decision-making process and advance the modernization of the drug development and approval process.”