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Trump signs FDA Reauthorization Act of 2017 into law
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President Donald J. Trump recently signed the FDA Reauthorization Act of 2017 into law.
The FDA Reauthorization Act of 2017 (H.R. 2430) reauthorizes the user fee programs for prescription drugs, medical devices, generic drugs and biosimilars, and amends FDA authorities and activities related to medical products. The user fees, which are paid by manufacturers of drugs and medical devices, account for $8 billion to $9 billion during a period of 5 years. The law includes the Generic Drug User Fee Amendments, the Biosimilar User Fee Act, the Prescription Drug User Fee Act and the Medical Device User Fee Amendments, which must be reauthorized by Sept. 30.
“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,” Tom Price, MD, HHS Secretary, said in a statement. “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.”
A discussion draft of the FDA Reauthorization Act of 2017 was released in April by bipartisan leaders of the Energy and Commerce Committee and bipartisan leaders of the Senate Health, Education, Labor and Pensions Committee. The draft was followed by a series of hearings that examined the four, individual user fee programs before being advanced through a voice vote in May and passed out of the full committee by a vote of 54-0 in June. The legislation was passed by a voice vote in the U.S. House of Representatives on July 12 and by the U.S. Senate on Aug. 3. – by Casey Tingle
References:
www.alexander.senate.gov/public/index.cfm/pressreleases?ID=DBFB7836-3531-419F-B042-719933341E05