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Politics, Policy & Law

Angered by NIH’s Collins, Trump misfires and hits FDA Commissioner Hahn

Concerns about pace of trial enrollment for COVID-19 mAbs cause president to lash out

Concerns about the pace of clinical trial enrollment for COVID-19 mAbs cause the president to lash out.

Aug 24, 2020 | 10:16 PM GMT

President Donald Trump’s recent attacks on FDA were prompted by Trump’s anger at NIH Director Francis Collins for delaying authorization of COVID-19 convalescent plasma, individuals who have been in close touch with the White House told BioCentury. Trump’s misunderstandings about the roles of FDA and NIH, and concerns about the pace of clinical trial enrollment for COVID-19 mAb candidates, caused the president to lash out at FDA and its commissioner, Stephen Hahn, rather than Collins.

FDA was poised to issue an Emergency Use Authorization (EUA) last week for COVID-19 convalescent plasma. It put the plans on hold after Collins objected, citing a lack of data from randomized, controlled trials. NIH has no formal role in FDA’s regulatory decisions and the agency has in the past disregarded his concerns.

The delay infuriated Trump, who attributed the delay to foot-dragging at FDA, sources told BioCentury.

Trump learned about Collins’ intervention in the plasma EUA process around the time he was told that clinical trial enrollment for a COVID-19 mAb candidate from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) was proceeding more slowly than officials at Operation Warp Speed officials had hoped.

Trump conflated NIH with FDA, failed to distinguish between mAbs and vaccines, and vented his anger in a tweet on Aug. 22, sources who are in touch with Operation Warp Speed and senior White House officials told BioCentury. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA.”

The tweet reflected Trump’s belief that government officials were slow-walking the convalescent plasma EUA, White House Chief of Staff Mark Meadows said on an Aug. 23 Fox News program. Trump’s remarks broke the EUA logjam, he said. “It was a fumble by a number of people in the federal government that should have done it differently. Having been personally involved with it, sometimes you have to make them feel the heat if they don't see the light.”

Speaking at a press conference Aug. 23, Trump reiterated his belief that unidentified government officials at FDA and HHS are deliberately slowing the development of COVID-19 medicines for political reasons.

The accusation, along with Trump’s public pressure on FDA to grant the plasma EUA and Hahn’s failure to defend his staff, dismayed former senior FDA officials.

While opinions among former FDA officials about the EUA decision are mixed, there is widespread agreement that it was marred by political posturing, including statements by Hahn, HHS Secretary Alex Azar and Trump exaggerating the strength of the evidence supporting the EUA (see “Ex-FDA Officials: EUA May Be Merited, but FDA Put Politics Ahead of Science”).

Responding to criticism of the EUA on Twitter, former FDA Commissioner Scott Gottlieb said the authorization decision was made by staff at FDA’s Center for Biologics Evaluation and Research (CBER). He also criticized the way it has been presented to the public. “I am confident in the science part of the evaluation executed by CBER. The way the public part was handled will erode precious public confidence,” he wrote, adding that public confidence is earned “in small drops” and lost “in buckets.”

Hahn, who has not refuted the president’s assertion that FDA staff are holding up COVID-19 treatment to diminish his chances of being reelected, has taken steps to assure Trump of his loyalty. These include retweeting Trump’s use of the term “China virus” to describe SARS-CoV-2, and issuing a press release that called the plasma EUA “another achievement in [the] administration’s fight against [the] pandemic.”

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