Weekend Reading: FDA’s Rollout of Plasma EUA Draws Skepticism

August 24, 2020

Scientists react negatively to FDA's handling of the Emergency Use Authorization for convalescent plasma in COVID-19.

Sunday’s announcement from FDA of an Emergency Use Authorization (EUA) for the use of blood plasma from those recovered from coronavirus disease 2019 (COVID-19), as a treatment for patients soon after COVID-19 symptoms appear, brought intense reaction from scientists, on Twitter and beyond.

Even physicians who favor studies of convalescent plasma as a treatment for COVID-19 winced at the scene of President Donald Trump announcing a “major therapeutic breakthrough,” with HHS Secretary Alex Azar and especially FDA Commissioner Stephen Hahn, MD, in tow. Not lost on anyone was the fact that days earlier, Trump had accused a mythical FDA “deep state” of moving too slowly on COVID-19. In particular, Hahn’s claim Sunday that plasma with certain antibodies had produced a 35% reduction in mortality rate raised questions, because the source supporting that statement was not immediately clear. STAT News reported that an FDA staff member whose name was left off a memo tempered his enthusiasm.

Ashish Jha, MD, director of Harvard’s Global Health Institute, tweeted that while FDA had the authority to issue the EUA and the “data might even meet the criteria,” the “hyperbole” and overselling of the evidence by Hahn was “very disappointing” and would make clinical trials more challenging. FDA’s credibility took a “big hit,” Jha said.

Meanwhile, former Commissioner Scott Gottlieb, MD, offered his former colleagues a partial defense, saying he firmly rejected Trump’s claims that FDA was “slow walking” coronavirus treatments. Gottlieb tweeted that he was “confident in the science part of the evaluation,” from FDA. He continued: “The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you lose it in buckets.”