President Trump signed the FDA Reauthorization Act of 2017 (FDARA) (H.R. 2430) into law on August 18, 2017. The law reauthorizes the FDA’s various user fee programs, which aid in funding the agency’s various oversight activities—providing over one-fourth of all FDA funding. The law extends the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) through fiscal year (FY) 2022 (FDA Reauthorization Act of 2017, August 18, 2017).
User fees. The FDA collects user fees from sponsors of brand name drugs, generic drugs, medical devices, and biosimilar biologics. Some exceptions apply, and no fees are collected for supplemental new drug applications and drug manufacturing facilities, classification of medical devices substantially equivalent to marketed devices, generic drug applications submitted by government entities, and supplements to generic drug applications or supplemental biosimilar applications. The new law eliminates the agency’s authority to waive or reduce medical device user fees in the interest of public health (see Bipartisan bill authorizing FDA user fees heads to the President’s desk, August 4, 2017).
Support. Various members of Congress have offered significant support for the bill. The U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) noted that committee Chairman Lamar Alexander (R-Tenn) and Ranking Member Patty Murray (D-Wash) coauthored the bill, and both senators are pleased to see the bipartisan efforts to strengthen medical research continue through this new law. Several members of the House Energy and Commerce Committee offered their support of the reauthorization, as did HHS Secretary Price.
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