On August 18, 2017, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).
“By signing the FDA Reauthorization Act of 2017 into law, President Trump is ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices,” said Health and Human Services Secretary Tom Price, M.D. “The law will support our team at FDA as they carry out the HHS mission to enhance and protect the health and well-being of the American people and continue to advance medical breakthroughs.”
Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research; Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health; and Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research said in a joint statement on the FDA Voice blog, “As directors of FDA’s three medical product centers, we want to applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA), which President Trump signed into law on Friday.”
For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product user fee act in 1992, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in the United States allowing patients access to new and innovative treatments as quickly as possible without compromising the FDA’s high standards.
FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing the FDA to continue to collect medical product user fees through fiscal year 2022. The new law marks the culmination of two years of negotiations with industry and discussions with stakeholders. This is a compelling example of what can be achieved when the FDA, industry, patients, Congress, and other stakeholders work together towards the same goal.
FDARA will help the FDA continue the essential work it is doing in many of its priority areas. The new law provides critical support for important FDA activities related to medical product regulation, including:
- Allowing the FDA flexibility to inspect medical device facilities based on risk, enabling the FDA to focus its resources where they are most needed, while providing greater predictability and transparency to the inspection process.
- Advancing and facilitating the development and timely approval of drugs and biologics for rare diseases, including diseases of children. In particular, FDARA provides the FDA with new authority to require a pediatric investigation into an adult cancer drug if that drug is directed at a molecular target that is relevant to a pediatric cancer.
- Providing resources for the popular, highly successful, and resource intensive breakthrough therapies program for drugs.
- Continuing to leverage the use of “real-world” health data to inform regulatory decision making, including enhancing the capabilities of the FDA’s Sentinel System for drugs.
- Strengthening the FDA’s partnership with patients by providing funding for the development of the National Evaluation System for health Technology (NEST) to help pay for a NEST Coordinating Center and pilot projects. NEST is intended to facilitate the use of real world evidence to support premarket activities.
- Establishing a flexible and more efficient path to market for certain new medical device accessories, to enable new and innovative accessories to come to market more rapidly and enable accessories to be used with a wide range of devices – creating important options for patients.
- Creating a category of over-the-counter hearing aids which will help lower costs and enable access for patients who greatly need these devices.
- Providing new opportunities for early consultation on the use of new surrogate endpoints.
- Streamlining combination product review to enhance coordination and transparency between the FDA and industry.
- Improving FDA hiring and retention efforts including a dedicated unit for scientific staff and continuous independent assessment of the FDA’s hiring and retention operations.
As a whole, the reauthorization of PDUFA, MDUFA, GDUFA, and BsUFA will allow the FDA to improve upon the demonstrated successes of these programs, and in so doing, further benefit patients and affirm the United States’ standing as a global leader in biomedical innovation.
See the FDA Voice Blog post
See HHS Secretary Price’s Statement on the Signing of the FDA Reauthorization Act of 2017
See the FDA User Fee Program site