#FDA chief clarifies remarks about COVID-19 treatment following criticism

#FDA chief clarifies remarks about COVID-19 treatment following criticism

August 25, 2020 | 11:48am | Updated August 25, 2020 | 12:01pm

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.”

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“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.”

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

The agency’s reversal was announced Sunday, 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.

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At a news conference with Hahn and Health and Human Services Secretary Alex Azar on Sunday, 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.”

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“We feel broader use of plasma will truly benefit many patients but will require further study,” he said.

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