The head of the US Food and Drug Administration has clarified his remarks about a new COVID-19 treatment — and insisted politics had nothing to do with his agency’s decision to authorize its emergency use.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” FDA Commissioner Stephen Hahn tweeted.

“What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

Hahn also said the decision to authorize emergency use of convalescent plasma — which is derived from the blood of people who recovered from the coronavirus — “was made entirely by FDA scientists.”

“We at FDA do not permit politics to enter into our scientific decisions,” he said in a series of tweets Monday night.

“This happens to be a political season but FDA will remain data driven. On behalf of FDA’s 18,000 career employees, I want to reassure the American public about this commitment.”

Hahn’s mea culpa and defense of the FDA’s move followed the publication of a New York Times report that quoted medical experts who criticized his claims about the effectiveness of convalescent plasma.

During a Sunday news conference announcing the FDA’s authorization of its emergency use, Hahn, President Trump and Health and Human Services Secretary Alex Azar all suggested that a recent study showed the plasma had reduced coronavirus deaths by 35 percent.

The figure appears to have been based on a small subgroup of patients in a Mayo Clinic study, all of whom were younger than 80, weren’t on ventilators and got antibody-rich plasma within three days of being diagnosed with COVID-19, the Times said.

“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the paper.

Dr. Robert Califf, who was FDA commissioner under then-President Barack Obama, also tweeted that Hahn should “publish a correction.”

“I’m sure he meant to correctly state the translation from relative effect to absolute effect,” Califf added.

The FDA’s decision came after the agency had earlier halted emergency approval for the use of convalescent plasma.

It reversed course one day after President Trump accused “deep state” opponents within the agency of delaying action on the treatment to hurt his reelection bid against Democrat Joe Biden in November.

At Sunday’s news conference, Trump called the FDA’s decision a “truly historic” development that “will dramatically expand access to this treatment” and “save countless lives.”

Hahn tweeted Monday that the FDA’s scientists relied on “significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.”

“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,” he said.

Hahn also said that the emergency authorization was “not a final approval” that “FDA 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 said.



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