FDARA: Making a Difference for Industry and Patients

By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D.

Janet Woodcock

Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research

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 Agency’s high standards.

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.

Jeff Shuren

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

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 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 FDA, industry, patients, Congress, and other stakeholders work together towards the same goal.

FDARA builds upon the goals outlined in previous user fee agreements and in the 21st Century Cures Act and will help us continue the essential work we are doing in many of our priority areas. The new law provides critical support for important FDA activities related to medical product regulation, including:

  • Enhancing our ability to capture the patient voice in drug development.
  • Allowing FDA flexibility to inspect medical device facilities based on risk, enabling the Agency to focus its resources where they are most needed, while providing greater predictability and transparency to the inspection process.

    Peter Marks

    Peter Marks, M.D., Ph.D., is Director of FDA’s Center for Biologics Evaluation and Research

  • 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 FDA’s Sentinel System for drugs.
  • Strengthening our 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 FDA and industry.
  • Improving FDA hiring and retention efforts including a dedicated unit for scientific staff and continuous independent assessment of the Agency’s hiring and retention operations.

FDARA will help FDA continue to fulfill its important public health mission.

As a whole, the reauthorization of PDUFA, MDUFA, GDUFA, and BsUFA will allow FDA to improve upon the demonstrated successes of these programs, and in so doing, further benefit patients and affirm our nation’s standing as a global leader in biomedical innovation.

Peter Marks, M.D., Ph.D., is Director of FDA’s Center for Biologics Evaluation and Research

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research

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