On at least three additional, documented occasions during the Biden administration as Director of CBER, Marks disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda. In addition to ignoring and overruling FDA’s top vaccine scientists during the pandemic, Marks also overruled FDA career scientists and supported the approval of the Alzheimer’s drug ADUHELM; a decision later overturned. In 2023, he overruled his own staff scientists amid their concerns and those raised by an FDA Advisory Board to grant approval of ELEVIDYS, a gene treatment for Duchenne muscular dystrophy (DMD). Furthermore, in 2024 Marks expanded the approval of ELEVIDYS despite FDA staff objections and without FDA Advisory Committee input.
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