Both the Senate and House of Representatives have overwhelmingly passed legislation that reauthorizes FDA to collect user fees from industry to help accelerate the review of new drugs and medical devices. The Senate passed its version of the bill (S. 3187) on May 24, and the House passed its version (H.R. 5651) on May 30.
Industry-paid user fees fund about 60% of FDA’s drug review budget and 20% of its device center budget. Both the drug and medical device user fee programs are set to expire on Sept. 30, the end of the fiscal year for the federal government. If Congress is unable to finalize a reauthorization bill before then, FDA will have to lay off about 2,000 employees and its drug and device review processes will grind to a halt.