FDA Conflict Of Interest Policy May Be Biggest Conflict Of PDUFA Reauthorization
Commissioner Hamburg says the agency likely does not need legislation to improve its conflict of interest policy, but House members still say system needs reform.
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Reforms merit one sentence, which would end waiver caps for conflicts of interest, but it is unclear whether it will solve the problems patient groups and others have with the advisory committee selection process.
Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.
Bill looks to expand accelerated approval rather than create new approval pathways, and also would reform conflict of interest rules for FDA advisory committees.