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September 14, 2020 by J. RUSSELL TEAGARDEN and ARTHUR L. CAPLAN | Stat News

‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA

(Image: James Palinsad/Flickr)

How can Americans tell when the Food and Drug Administration has become so politically impaired that it cannot serve its mission to protect the public? One measure is when pharmaceutical manufacturers become the voice of caution and prudence about when new vaccines should be released to the public.

Hell has frozen over. Nine leading pharmaceutical and biotechnology companies issued a joint statement this week to assure the public they will not distribute their vaccines for Covid-19 before their safety and effectiveness have been firmly established.

There’s no question that the FDA is politically impaired. The Trump administration cowed it into announcing emergency use authorization for hydroxychloroquine and chloroquine for the prevention and treatment of coronavirus infection, only to revoke it later for lack of effectiveness and worries about adverse effects. A nervous public was then told of Operation Warp Speed for the development of a Covid-19 vaccine. We then witnessed the administration make a public display of its pressure on FDA leaders to approve a vaccine before the November elections.

The FDA’s leaders have done little to convince the public they will not capitulate to pressure from the Trump administration.

Trust in the FDA is an essential ingredient in introducing new drug therapies and successful vaccination programs. People won’t have confidence in medicines or vaccines that have not been evaluated by a credible and independent source.

This need was a driving motivation for the federal government to establish what was to become the FDA in 1906. Back then, consumers could not be sure which medicines were “snake oil” and which were “ethical” products that were not tainted or did not make false claims of benefits.

Over the ensuing decades, as the pharmaceutical industry took shape and began sophisticated marketing operations, the FDA became an important counterforce to the commercial objective to sell as much product as possible. That industry relied on the FDA to stop commercial practices that could pose greater risks than benefits.

Without a functioning FDA, pharmaceutical manufacturers can lose this important guardrail.

Except, apparently, when the guardrail is damaged. Incredibly, it is the long-term reputational risks and business motives of the pharmaceutical industry that are left to prevent a collapse in public trust. Vaccine makers are sensing this could currently be the case, with huge numbers of Americans expressing hesitancy about the Covid-19 vaccines in development because of the warp speed at which they are to receive FDA approval. So the companies are pledging to withhold their vaccines from commercial distribution until they themselves are satisfied they can be used with the confidence the FDA is otherwise expected to generate.

Should the public be grateful? We shouldn’t have to ask.

The two of us have a combined eight decades in health care. We have seen a lot during that time. But we never would have expected to see the pharmaceutical industry feel compelled to step into the role FDA is mandated to fill. It is ironic and tragic at the same time.

The political impairment the FDA is now experiencing is not irreversible. Leadership at the FDA strong enough to withstand pressure from an administration attempting to bend the agency to its political will — or an administration that would not pressure the agency to bend in such a way — could eventually win back public confidence.

The American people should have confidence that the FDA will protect us from half-baked or potentially harmful therapies. It’s unconscionable that we must rely for that instead on protection fueled in part by the business objectives and reputations of pharmaceutical and biotech companies.

 

Russell Teagarden is a member of the New York University School of Medicine’s Working Group on Compassionate Use and Pre-Approval Access. Arthur L. Caplan is professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics.

 

 

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