2021 Sep 21, 9:37am
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Study: FDA Has 'No Tradition or Structure to Ensure Consistency' in Decisions— Has regulatory "flexibility" gone too far? Former employees, advisor say yesby John Gever, Contributing Writer, MedPage Today September 20, 2021... "A perception of inconsistency with prior decisions breeds distrust in FDA decisions and belief that they are not being driven primarily by evidence, threatening the FDA's scientific, public, and political standing," Janiaud's group argued.Piling on was one of those advisory committee members who quit in protest. In an accompanying editorial, Joel Perlmutter, MD, of Washington University in St. Louis, suggested that industry influence was too strong at the FDA, "with more than half of the FDA budget provided by applicant companies."Not only should the "financial tether between the FDA and industry" be severed, but the agency needs "prospective rules for transparency," as well as more funding from Congress, Perlmutter wrote.