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Are Stephen Hahn’s days numbered at FDA?

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FDA Commissioner Dr. Stephen Hahn
FDA Commissioner Dr. Stephen Hahn

HHS Secretary Alex Azar has been reportedly discussing the removal of Dr. Stephen Hahn as FDA commissioner, according to Politico.

The Politico report cited a half dozen current and former administration officials.

FDA spokesperson Michael Felberbaum in an email to MassDevice denied an Azar-Hahn feud: “Commissioner Hahn enjoys a good relationship with Secretary Azar and speaks with him regularly.”

Politico‘s claim of a potential Hahn ouster comes after FDA openly defied President Donald Trump by telling COVID-19 vaccine developers that the agency needs two months’ worth of safety data before it will consider emergency approvals.

Hahn said EUAs will come after public hearings held by the Vaccines and Related Biological Products Advisory Committee. The committee, in fact, is holding a public meeting today.

“We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held by medtech trade group AdvaMed early this month.

As for when the process would result in an approval, Hahn repeated a phrase he used when cancer patients asked him about eventual outcomes: “I don’t have a crystal ball.”

The anonymous sources in the Politico report said White House officials were unlikely to greenlight Hahn’s removal before Election Day because of the bad optics. But should Trump win a second term as president, Hahn’s return to the agency is unlikely, the Politico sources said.

There are presently about half a dozen COVID-19 vaccine candidates in Phase 3 clinical trials. Trump has been calling on government scientists to quickly approve a vaccine — and criticizing vaccine trial guidelines.

 

 

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