FDA chief says agency’s vaccine approval process won’t be influenced by “pressure from anybody”


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Dr.Stephen Hahn testifies during a US Senate Senate Health, Education, Labor, and Pensions Committee hearing in Washington, on September 23. Alex Edelman/Pool/AFP/Getty Images

The US Food and Drug Administration won’t allow political pressure to interfere with the agency’s decision-making on a potential Covid-19 vaccine, FDA Commissioner Dr. Stephen Hahn said. 

Hahn sought to reassure Americans about the FDA’s vaccine development process at a discussion recorded on Tuesday with the National Consumers League.

When it comes to authorizing or approving drugs and therapeutics, “science will guide our decisions,” he told the group. “FDA will not permit any pressure from anybody to change that.” 

“I want to assure you that every one of the decisions we have reached has been made by FDA scientists, based on science and data, not by politics,” he said.

Hahn has been responding in recent days to concerns about political pressure potentially influencing the approval or authorization of coronavirus treatments or vaccines in recent days after President Trump said last week that the White House could overrule FDA rules on vaccine development.

But even before that, Hahn was criticized for announcing an emergency use authorization for convalescent plasma at a news conference with Trump in August. The agency also revoked an EUA for the malaria drug hydroxychloroquine in June, a drug pushed by Trump, because it didn’t work in Covid-19 patients and in fact, may have caused harm, studies found.

“I know that there’s been particular attention paid to a few of the decisions reached by FDA scientists over the past few months,” Hahn admitted. “As Commissioner, it’s my responsibility to help explain why support for and confidence in the FDA is justified,” he added.

“I want to assure you that every one of the decisions we have reached has been made by FDA scientists based on science and data, not by politics.”

Hahn told the NCL that if and when a Covid-19 vaccine is authorized or approved, Americans “should have complete confidence in that decision.”

“I will fight for science and data to guide our decisions,” he said. 

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