STAT Examines Involvement Of BARDA Official In Emergency Use Authorization Decision Over Malaria Drug, Usually Overseen By FDA
STAT: Why was an obscure federal bureaucrat involved in Trump’s emergency hydroxychloroquine authorization?
“Rick Bright, a bureaucrat at an obscure federal agency, burst onto the political stage this week with allegations that the Trump White House put politics ahead of science to advance an untested malaria drug as a coronavirus treatment — explosive claims that beg the question: Why was Bright involved in decisions about the drug at all? Bright does not work at the Food and Drug Administration, which governs nearly all of the nation’s decisions about whether medicines are safe and effective. … The Trump administration, though, did involve him in a controversial decision to use an arcane emergency authorization process to beef up U.S. supplies of the malaria drug, hydroxychloroquine. Bright says he pushed back vehemently and was subsequently demoted as a result. The Department of Health and Human Services, which oversees his old post, says Bright was the one who requested the emergency authorization in the first place. The issue raises a litany of questions about exactly who should have been — and who was — involved in the decision to ramp up supplies of the drug, especially since a STAT review of 10 years’ worth of public emergency authorizations shows that no one in Bright’s role has before been so closely involved. Sources tell STAT, too, that even high-ranking FDA officials were kept out of the loop in this instance…” (Florko, 4/24).