On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act. The House bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill would: take a variety of steps to protect the drug supply chain and alleviate drug shortages; permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; make a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); and revise the medical device and drug review processes. On May 24, the Senate approved its version of the legislation, S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1. A conference committee will be appointed to resolve differences between the House and Senate versions of the bills.
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House, Senate approve FDA User Fee/Drug Safety Bills
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