Several leading scientists — including a Johns Hopkins University researcher leading randomized, controlled trials of plasma — have said they can’t figure out how the administation arrived at its 35-to-1 statistic, based on the data the Mayo team published this month.
In a statement released Sunday, the FDA said plasma “does not yet represent a new standard of care based on the current available evidence.”
“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 wrote on Twitter on Monday. “The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”
Hahn’s defense comes as his agency has already faced pressure from all sides as it races to get a coronavirus vaccine to market in record time.
The FDA commissioner has worked in recent weeks to rebut concerns that his agency might bow to political pressure as it expedites oversight of work on coronavirus treatments and vaccines. Hahn has offered assurances that FDA won’t sacrifice the safety or efficacy of a coronavirus vaccine for the sake of speed — even as the president is pushing the agency to move faster.
The commissioner’s actions Sunday, which came after Trump accused the FDA of slow-walking the therapy to harm his reelection, renewed many public health experts’ fears that the administration will rush through a Covid-19 vaccine without proof that it works.
In an interview with POLITICO, Hahn explained that “I thought it was really important for the American people and the agency, the FDA, to correct that record” the plasma decision, which he said he wanted to stress was made by career officials.
“I 100 percent stand behind” the scientists at the Center for Biologics Evaluation and Research and its director, Peter Marks, Hahn added. “As we get more data, if we have to change the EUA, we will change it.”