FDA Commissioner Stephen Hahn issued a mea culpa late yesterday, conceding that he had overstated the benefits of convalescent plasma as a treatment of coronavirus at a press conference last weekend with President Trump
for the treatment on Sunday, the White House billed the decision as a “historic announcement.”
The authorization was based on anecdotal data from a 70,000-person program run by the Mayo Clinic. Hahn defended the use of that data to issue the emergency use authorization, arguing that FDA scientists made the decision to approve emergency use of the treatment “a few weeks ago” and that while questions may remain about its efficacy, “the safety profile is well defined.”
“We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program,” Hahn tweeted. “The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”
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