Trump’s FDA Chief: More ‘Safeguards’ Needed Against Presidential Pressure

WASHINGTON, DC - AUGUST 23: FDA Commissioner Stephen Hahn looks on as President Donald Trump announces that the Food and Drug Administration is issuing an emergency authorization for blood plasma as a coronavirus treatment during a press conference in James S. Brady Briefing Room at the White House on on August 23, 2020 in Washington, DC. The move by the FDA comes after President Trump accused the FDA of slow-walking the therapy to harm his reelection chances.(Photo by Pete Marovich/Getty Images)
WASHINGTON, DC - AUGUST 23: FDA Commissioner Stephen Hahn looks on as President Donald Trump announces that the Food and Drug Administration is issuing an emergency authorization for blood plasma as a coronavirus tre... WASHINGTON, DC - AUGUST 23: FDA Commissioner Stephen Hahn looks on as President Donald Trump announces that the Food and Drug Administration is issuing an emergency authorization for blood plasma as a coronavirus treatment during a press conference in James S. Brady Briefing Room at the White House on on August 23, 2020 in Washington, DC. The move by the FDA comes after President Trump accused the FDA of slow-walking the therapy to harm his reelection chances.(Photo by Pete Marovich/Getty Images) MORE LESS
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February 8, 2021 11:54 a.m.
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The FDA commissioner who President Trump pressured for months to approve a COVID-19 vaccine before the 2020 election thinks that the agency should be independent.

Former FDA commissioner Stephen Hahn said on an episode of the In The Bubble podcast released Monday that a “serious conversation” should take place about carving out an independent role for the regulator.

Trump pressed Hahn for months, in public and private, to authorize COVID-19 vaccines for use before the November election and before clinical trial data showed that they worked.

“We were in the middle of an election season, and folks wanted wins, basically,” Hahn said.

In response to a question from podcast host Bob Wachter about the pressure he faced to rush a pre-election vaccine, Hahn described himself as “politically naive.”

“I think we’ve learned from this that, given the importance the FDA has in the regulation of medical products and consumer products, there need to be more safeguards in place,” he added.

The FDA managed to ward off attempts at forcing a rushed COVID-19 vaccine in part by installing regulations that set a timeframe for vaccine safety data. The timeframe effectively made it impossible for drug manufacturers to petition the agency for emergency use authorization until after the election took place.

Hahn said that his agency had “put a stake in the ground” to make sure that the vaccine approval process was followed without political interference.

“What would you have said if we had short-changed that process and truncated that without good explanation or rationale,” Hahn asked Wachter, the podcast host and the Department of Medicine chair at the University of California, San Francisco. “My guess is you would have said, what the heck, you guys are caving to pressure.”

In the interview, Hahn described other episodes of political pressure, ranging from the White House boosterism of hydroxychloroquine at the start of the pandemic to the monumental fight over whether clinical trial data or electoral politics would drive the approval of a vaccine.

He added that Trump’s public enthusiasm for hydroxychloroquine, without data showing that it helped at all against COVID-19, had led to a run on the drug last year.

“A lot of physicians were writing prescriptions for themselves and for nursing staff and for frontline healthcare workers, first responders, etc.,” Hahn said, adding that it had caused “significant pressure on the system.”

Trump accused a “deep state” at the FDA in August of slowing down the vaccine and other drug approvals to damage him. After regulators authorized the vaccine for emergency use in December, Trump told Hahn to “stop playing games and start saving lives!!!” in a now-annihilated tweet.

Hahn said on the podcast that he and Trump spoke regularly.

“We had a very honest exchange,” Hahn said about the COVID-19 vaccine. “I made it clear what our processes and procedures would be, and the reason we had to do it.”

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