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Top FDA official overrules staff to approve gene therapy that failed trial
Peter Marks overruled three teams and two top directors.
In fact, the decision to expand the approval of the therapy— called Elevidys(delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research. Advertisement The move, which follows a string of controversies in recent years of the FDA issuing questionable approvals over the assessments of advisors and its own staff, has quickly drawn criticism from agency watchers. In a comment to Stat News, former FDA chief scientist Luciana Borio echoed concerns about how decisions like this will affect the agency in the longer term.
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