FDA head needs to tell Trump the agency is not part of ‘deep state’ – STAT

The next 73 days are going to be very difficult for Stephen Hahn.

As the Nov. 3 election nears, the Food and Drug Administration commissioner can expect intensifying pressure from President Trump to approve a vaccine or a drug to combat Covid-19. Desperate to win and angry at criticism of his handling of the pandemic, Trump twice this week complained that the deep state may cause a delay.

But on Saturday morning, Trump also singled out the FDA by tweeting, without evidence to support his claim, that the agency is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. To make sure the FDA head got the message, Trump tagged Hahn at the end of the tweet.

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These sorts of self-serving remarks are terribly wrongheaded, because they continually raise the specter of political interference with a key agency during a severe public health crisis. Who would trust a vaccine that is being rushed out the door just so Trump can say he delivered what everyone wants as soon as possible? His tweets are about his re-election, not our well-being.

For Hahn, however, this creates a different kind of crisis, because the political appointee has to work harder than ever to ensure the FDA remains independent.

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One of the great things about FDA is that decisions are made by full-time civil servants without conflicts, former FDA commissioner Robert Califf tweeted in response to Trumps tweet.

But Hahns track record gives me pause, and Im not so sure he can stand up to Trump.

After all, last March, the agency authorized emergency use of hydroxychloroquine, a decades-old malaria tablet that Trump was touting, even though there was only tenuous evidence it could help patients infected with the coronavirus.

Hahn should have fought harder to resist that move. Sure, by late June, the FDA did an about face and revoked the authorization, after more solid data began appearing that made it clear the tablet was not the salve Trump and others thought and might be harmful.

By then, though, the damage was done. Too much energy was spent testing a tablet simply because Trump had a hunch it could be useful, and this may have precluded researchers from exploring other possibilities that could have yielded something beneficial.

Since then, Hahn has tried to atone.

Earlier this month, he took a double-barreled approach with a pair of editorials targeting the medical community and the political crowd. He co-authored an op-ed in JAMA about upholding standards for vaccine approvals and made the same vow in an op-ed of his own in The Washington Post.

But it was hard to miss that Hahn failed to rule out the possibility of another emergency use authorization. Yes, the FDA needs this authority, but only if it is put to proper use. So this begs the question will he acquiesce a second time?

Look, I understand Hahn is in a rough spot. Trump is mercurial and selfish. Hes not interested in upholding FDA standards for assuring safe and effective products. He has an election to win.

Ironically, the FDA hardly appears to be an impediment to getting a vaccine or therapy ready. Vaccine makers, for instance, are moving faster than was previously imagined possible to develop and test Covid-19 candidates. And the agency has already scheduled an Oct. 22 meeting to review data from vaccine trials underway.

The challenge for Hahn is to push back and not sign off on any vaccine or drug unless there is credible evidence that it meets the criteria the agency uses to assess safety and effectiveness.

Earlier this month, Peter Marks, who heads the FDAs Center for Biologics Evaluation and Research and is part of a vaccine working group organized by the National Institutes of Health, threatened to resign if the FDA rubber stamps a Covid-19 vaccine.

Marks didnt make that threat publicly, but it was subsequently reported and only further raised concerns about the possibility of politicizing any FDA approvals.

Hahn should do the same. Well-placed editorials may preserve views for the record, but Hahn needs to make clear not only to the public, but to Trump that FDA decisions are made to serve the public, not help re-elect a president.

After all, Hahn is an experienced oncologist who has helped run a major cancer center. Unlike the millions of Americans out of work right now, he can find another job.

Rather than duck, Hahn needs to push back even more and defend the FDA staff. He should tweet that the agency is not part of the deep state and that a vaccine will be approved only when one is ready.

Otherwise, those 73 days are going to be very agonizing for all of us.

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.

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FDA head needs to tell Trump the agency is not part of 'deep state' - STAT