Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
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Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
The emergency use authorization for convalescent plasma in August 2020 on weak data from an expanded access program has largely been viewed as a politically charged decision by the Trump administration. But newly revealed emails from the run up to the decision indicate Center for Biologics Evaluation and Research Director Peter Marks backed the plan.