House passes bipartisan FDA user fee legislation as it aligns with Senate on accelerated approval reforms
Last night the House overwhelmingly passed a package of legislation, by a vote of 392-28, that will reauthorize FDA user fee programs — funding agency reviews of drugs, medical devices, generics and biosimilars — as well as other attached reforms, setting up what is expected to be some heavy negotiating with the Senate as the two sides have several major differences.
The quinquennial (every 5 years) user fee bill will fully fund the FDA and allow the agency to hire new reviewers, particularly in CBER, and hit new review marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years. (Congressional appropriations make up less than half of the FDA’s latest budget.)
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