President Donald Trump touted a COVID-19 vaccine ready for Election Day, and behind the scenes, his officials tried to make it happen. But despite intense pressure, the FDA publicly rolled out stricter safety guidelines that thwarted those hopes—and now Commissioner Stephen Hahn, M.D., is reportedly at odds with his boss, HHS chief Alex Azar.
The agency posted those guidelines—which call for two months of safety data before FDA review for an emergency OK—in defiance of resistance from the White House, according to reports this week from Politico and The New York Times. For instance, before the FDA made its move, chief of staff Mark Meadows told Hahn the White House wouldn't approve the new guidance, so he should forget it, NYT reports.
And in the weeks since FDA went rogue to publish the guidelines, HHS Secretary Alex Azar has openly discussed removing Hahn from his post, Politico reports, citing current and former officials. He’s even considered potential replacements.
Representatives for FDA and HHS told Politico that Azar and Hahn have a good relationship and are in contact often. An HHS spokesperson didn’t directly address the issue of Azar’s confidence in Hahn as FDA commissioner, citing policy against discussing personnel issues in the media, Politico reports.
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Since he was confirmed as FDA commissioner by the Senate in December, Hahn’s tenure has been dominated by COVID-19. He’s faced pressure from the Trump administration throughout the pandemic and wavered back in the spring when the agency issued an authorization for the Trump-backed drug hydroxychloroquine despite limited evidence.
But Hahn’s biggest misstep was in August, when he made inaccurate statements about convalescent plasma at a briefing with Trump and Azar. Hahn said the treatment was associated with a “35% improvement in survival,” but experts pointed out the claim wasn’t backed by evidence.
Though he corrected himself and accepted criticism, the moment led to a crisis of confidence among FDA experts, according to the NYT and Politico. From there, Hahn set out improve the FDA’s standing among the scientific community, and his own standing at the agency.
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Then came the vaccine guidance showdown. The FDA submitted its recommendations to the White House in early September, the New York Times reports, but scientists worried they’d never see the light of day.
As the White House stalled, the FDA released them within materials for an FDA meeting set for today. That move infuriated Azar, but it’s unlikely the White House will remove its commissioner at the moment, sources told Politico.