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Editor’s Commentary

FDA should maintain ‘social distance’ from the White House

Aug 31, 2020 | 11:47 PM GMT

One of the most important public health tools to emerge this year is the concept of social distance. Its benefits aren’t limited to outdoor dining or supermarket checkout lines; they extend to interactions between science-based public health agencies and politicians.

FDA Commissioner Stephen Hahn’s failure to maintain social distance from President Donald Trump is imperiling the ability of the U.S. — and other countries that are looking to the U.S. for leadership — to respond to COVID-19.

The appropriate social distance between Hahn and Trump is about 12 miles, the space between the agency’s headquarters and the White House.

In case evidence was needed, the examples of hydroxychloroquine and convalescent plasma show that White House press conferences are the worst place for FDA commissioners to disclose complex, controversial regulatory decisions like emergency use authorizations (EUAs).

Those debacles, which have vaporized decades of public trust in FDA, will seem inconsequential in comparison to a botched COVID-19 vaccine EUA.

Decisions about authorization of a vaccine in the midst of a pandemic, based on a small fraction of the data ordinarily required, are about as complex as it gets. They should not be made under political pressure, and they certainly should not be announced in a partisan setting or against a political backdrop.

Hahn has irrevocably lost the trust of large portions of the American public.

The best he can do now is ensure and communicate that future decisions will be based on the expert judgments of career staff acting transparently based on publicly available data.

FDA has already laid out reasonable criteria for authorizing or approving COVID-19 vaccines. Now it needs to use its Oct. 22 Vaccines and Related Biological Products Advisory Committee meeting to commit to adhering to those criteria, obtain advice on how it should do so, and listen to that advice.

Critically, the committee needs to spell out the distinction between FDA determining that a vaccine candidate has met the legal threshold for an EUA and a decision to grant an EUA. The fact that FDA can do something doesn’t mean that it should.  

When FDA receives a COVID-19 vaccine EUA request, Hahn should commit to reconvening the committee to recommend whether authorization is in the public interest.

Benefits and risks

FDA and its advisory committee will need to consider whether the risks posed by delaying authorization of a COVID-19 vaccine based on a promising but small dataset are greater than the benefits of waiting a few months for more certainty.

Allowing a vaccine onto the market prematurely would make it almost impossible to fully characterize its safety and efficacy because it would be difficult to conduct additional placebo-controlled trials. Jumping the gun would also fuel vaccine hesitancy, especially if unanticipated adverse events are detected after authorization.

The decision will be difficult and controversial.

Delaying a safe, effective vaccine would cause further deaths and long-term pathologies from COVID-19, worsen economic devastation and prolong the harm students and others have experienced as a result of measures to contain SARS-CoV-2.

The COVID-19 situation is unusually complex because there are compelling public health arguments in favor of ensuring that multiple vaccines are available. Whenever a vaccine is authorized or approved, FDA must take care to minimize the disruption of ongoing and future trials of other vaccine candidates.

The political dimension

While regulators grapple with considerations of benefit and risk every day, the pandemic raises unique concerns of a different dimension. A paramount question is whether the public can trust FDA’s leadership to decide on EUA of COVID-19 vaccines based on an independent assessment of the data, untainted by political considerations.

By elevating concerns about White House interference in FDA’s decisions from the realms of conspiracy theories to a topic of legitimate concern, Hahn, Trump and HHS Secretary Alex Azar have created a situation that has undermined confidence in regulatory decisions.

They have done this in part by touting ineffective treatments and by exaggerating the strength of data about potentially useful treatments.

The public can only be kept safe by regulators who are appropriately skeptical of unproven claims — and by leaders who accept science-based decisions.

FDA’s job is to carefully assess imperfect and incomplete evidence, weigh benefits and risks, and arrive at decisions that it can credibly justify to the public.

To prevent a catastrophic loss of confidence, the agency must adhere to the criteria it articulated in guidance on approval standards for COVID-19 vaccines.

Because Hahn has lost credibility, any decision to authorize a vaccine, especially if it is made prior to the elections, should come only after an independent and public assessment of the evidence.

Too much is at stake to simply hope for the best, or to allow a good decision to be marred by chest-thumping, divisive political boasting.

Editors’ commentaries do not necessarily reflect the views of BioCentury.

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