Food and Drug Administration Commissioner Stephen Hahn conceded on Monday night that he had exaggerated the effectiveness of convalescent plasma therapy as treatment for COVID-19 the day before.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn tweeted. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
The official clarified that the agency’s emergency approval of the treatment “is not a final approval” and that FDA scientists will “continue to monitor its use and will revoke authorization if needed.”
“We feel broader use of plasma will truly benefit many patients but will require further study,” he tweeted.
Hahn also denied that the authorization, which had been touted by President Donald Trump in his desperate efforts to bolster his reelection chances, was motivated by politics even as Trump pressures the FDA to approve treatment by November.
“We at FDA do not permit politics to enter into our scientific decisions,” Hahn tweeted. “This happens to be a political season but FDA will remain data driven.”
During a press briefing with Trump on Sunday, Hahn had heaped praise upon convalescent plasma therapy, claiming it had reduced the mortality rate among COVID-19 by as much as 35 percent.
“We dream in drug development of something like a 35 percent mortality reduction,” the FDA official said. “This is a major advance in the treatment of patients. This is a major advance.”
