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.

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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.

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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.

  • Covid is unprecedented. FDA lost public confidence when they proclaimed to not wear masks. Then playing favors to the Dems. Are Big Parma playing favors to the Dems as well? It’s time to get on with this emergency and not play to over-arching requirements. We sometimes call it Engineering Judgement.

  • And we are supposed to believe that the pharmaceutical industry’s motives are pure? Pardon my skepticism, but isn’t this exactly what we need to fear the most: that the pharmaceutical industry vociferously denies that they allowed themselves to be pressured by politics when they report a successful vaccine test just before the election; wink wink.

  • The FDA feels very compromised to me in several areas related to our food supply.
    Poor quality foods, often referred to as “junk” foods are readily available at low prices and wreak havoc with the health of our population, but may take a decade or so to appear as “sickness “, such as obesity or type 2 Diabetes.
    Many of the pandemic deaths in this country are related to people with these issues.

  • so if Big Pharma is so concerned abut the health of Americans then why in 2018 citizens in the US spent 365 BILLION with a B on drugs and medicines or 3 to 4x what any other country in the world spends on drugs per capita ; furthermore then why did congress pass a law making it illegal for Medicare part D to negotiate drugs prices which are 70 % cheaper at the VA for he same drugs ; so much for caring about the health if it’s citizens where many can not even afford the drugs to keep them alive ; a total PR con

    • Yes this article feels like the superhero is coming to the rescue so people get a different perspective of big pharma. At the same time- I am against hurrying a vaccine as well but the bigger question is why aren’t we looking closer at Sweden’s approach. They admit to not protecting their elderly early on?

  • So STAT doesn’t like our President? Who cares? These graceless jabs only serve to inspire questioning your publication’s credibility about everything else, whether the rest has been similarly tainted by “attitude.”
    Also, it’s frankly nit-picking to accuse the President of “bullying” the FDA, given the recently revealed illegal intimidation tactics of his predecessor. (You won’t read about this in mainstream press). Our President could be bullying the FDA. After all, he is generally transparent in his attitudes toward others, perhaps sometimes to a fault. On the other hand, could it be the FDA needs some bullying? Someone has to tell them to do their jobs whether they like Mr. Trump or not. Their precious “feelings” about the President are irrelevant.
    Weren’t we all supposed to have learned that in Kindergarten?
    All one has to do is peruse the FDA minutes of a drug approval meeting to grasp the magnitude of trade-off’s made that are never spelled out to the patient.
    That would make an interesting article. As a practitioner and patient, I don’t care who you like or not like. Give me real news about what’s not disclosed or is tucked in an addendum that will help me guide patients and myself.
    Peggy Finston MD

    • Don’t we all feel better already? And what is the logic backing up your rant? I’m sure your portfolio is doing well… as it should, in the short term, after four years of wild deficit spending. I’m sure your taxes are lower, so you can by the bigger BMW. But it won’t last.

    • Great comment! Why-because your disclosing a bias in the author of this topic! If you look at Adesh Amilja(spelling?) he supports AOC. Take a look at the interview between the two regarding Covid. I do not advocate finding a vaccine for political gain in any circumstance. Vaccines are not the only end all like in countries in Sweden for the remedy to this pandemic. Pharmaceutical companies are portrayed as a hero in this article in my opinion and it is an illusion of the mind. Summary- individuals who are educated in biases who exploit them should be held at a higher standard. Are vaccines held too high for life saving measures when people like Fauci have a conflict of interest in them? Thoughts?

    • Dr. Finston appears to be one of the supporters Trump bragged about supporting him even if he killed someone in cold blood on Fifth Avenue in New York City. Her rant reads more like a Trump stump speech than a rational challenge to the very real loss of faith in both the FDA and CDC because of the willingness of their directors to kowtow to Trump’s deranged beliefs.

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