FDA to authorize plasma treatment over scientists' objections
The Food and Drug Administration will issue an emergency authorization for blood plasma as a coronavirus treatment, President Donald Trump is set to announce Sunday evening, according to three administration officials.
The agency held off on the decision last week over concerns from government scientists that evidence for the treatment's effectiveness is thin — prompting Trump to accuse the FDA of slow-walking the therapy to harm his reelection chances without offering any evidence to support his claim. It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy's use.
An emergency authorization normally paves the way for expanded use of an experimental therapy. But it is not clear what effect the FDA's decision will have in the case of so-called convalescent plasma, which more than 70,000 Americans have already received — largely outside of randomized, controlled clinical trials that could prove whether the approach is effective.
Trump will announce the emergency authorization alongside his health secretary, Alex Azar, and FDA Commissioner Stephen Hahn, in a press conference one day before the start of the Republican National Convention. White House Press Secretary Kayleigh McEnany said the announcement would involve a "major therapeutic breakthrough," but experts have said the treatment is unlikely to be a game-changer in the fight against a pathogen that's killed more than 170,000 in the United States.
https://www.politico.com/news/2020/08/23/plasma-treatment-coronavirus-fda-trump-400390
= new reply since forum marked as read
