FDA’s Woodcock on authorizing emergency use for hydroxychloroquine: ‘We did the best we could’
Over the past few weeks, the Food and Drug Administration has been criticized for some of the steps taken – and not taken – to combat Covid-19. High on the list was a decision to grant an Emergency Use Authorization to allow hospitals to provide a pair of decades-old malaria drugs, which were touted by President Trump, even though there is no evidence the medicines may be useful in patients stricken by the novel coronavirus. We spoke with Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, about this decision, as well as the steps her division is taking to maintain quality control standards at manufacturing plants and keeping advisory committee reviews on track. This is an edited version of our conversation.
Do you worry that hydroxychloroquine overuse threatens to undermine the standard FDA review process and the respect that the public has for that process?
