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FDA Touts Bipartisan FDARA, Now Law

Aug 21, 2017

Friday night, President Trump signed into law a bipartisan health care bill – H.R. 2340, the FDA Reauthorization Act (FDARA) of 2017. Composed of a five-year reauthorization of FDA’s critical medical product user fee programs and other important reforms, H.R. 2430 ensures the agency has the tools it needs to more efficiently deliver safe and effective drugs, devices, and treatments to patients.

But don’t take our word for it. FDA’s leading officials took to the agency blog today highlighting how this new law will make “a difference for industry and patients.”

“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,” write the agency officials. “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.”

FDARA: Making a Difference for Industry and Patients

By Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, and Dr. Janet Woodcock, 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.

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 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.

Click HERE to read the blog online.

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