FDA leaders are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public scrutiny. The FDA "would like to get away" from assembling panels of experts to examine and vote on individual drugs, because "I don't think they're needed," said George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research. He relayed the message at a meeting of health care product makers and to an FDA advocacy group. In addition to being redundant, Tidmarsh whined, advisory meetings on specific drugs were "a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions."
The FDA's advisory committees were created in 1972 aimed at expanding and regulating the government's use of experts in technical decisions. They're periodically summoned for advice, including to review evidence and vote on whether the FDA should approve drugs, vaccines, and medical devices, often when FDA officials face a difficult decision. FDA actions have traditionally aligned with committee votes. A departure can provoke controversy and public debate, as was the case with the split 2021 decision on whether to approve the Biogen drug Aduhelm to treat Alzheimer's disease. At NIH, a Dummkopf Trumpf executive order gave political appointees more say in fund-granting decisions, letting political priorities override peer review in research funding decisions.The impact of FDA advisory committees has been significant in areas of infectious disease control, cancer treatment, and drug safety oversight. This is just another move to make Americans, who are already suffering without universal healthcare and rising medical insurance costs, less safe and healthy under mentally unstable HHS Secretary Robert F. Kennedy Jr and the nefarious Dummkopf Trumpf junta. And who knows what snake oils and quack nostrums junta insiders will be be pushing on the American people in the near future?
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