All signs point to the Food and Drug Administration quickly authorizing the emergency use of several highly effective vaccines for COVID-19. This is an extraordinary scientific achievement given only a year has passed since the deadly coronavirus emerged in central China.
It will take an equally extraordinary effort to convince enough Americans to take the shots. Public confidence in the two agencies responsible for guaranteeing vaccine safety and effectiveness and their fair distribution—the FDA and the Centers for Disease Control and Prevention—has reached a nadir.
In polls taken a few months before the election, two-thirds of Americans believed the vaccine approval process had been tainted by politics. More than a third of the public—including substantial numbers of front-line healthcare workers—said they wouldn’t get vaccinated.
It’s easy to understand how two agencies once considered gold standards in their fields were brought low. The outgoing administration did everything in its power to undermine their credibility.
The FDA caved to the president’s demand to grant emergency use for a drug that eventually proved useless in fighting the disease. HHS Secretary Alex Azar took away health agencies’ authority to issue new rules, then sought to block the FDA’s new guidelines governing emergency use authorizations—all to further his boss’ re-election.
The CDC leadership stood by silently as political appointees censored its flagship publication. CDC scientists and Dr. Anthony Fauci at the National Institutes of Health were “disappeared” from coronavirus task force briefings. The White House repeatedly contradicted CDC guidelines while state public health officials in some parts of the country worked under death threats.
It will take a sustained effort by the incoming Biden administration to rebuild trust in America’s public health infrastructure. It begins by his appointing new leaders at HHS, and the CDC and FDA who are fully committed to insulating agency scientists from political pressure.
After Biden’s inauguration, the administration should rapidly push legislation to permanently restore independence at science-based agencies. Such legislation should give the heads of all such agencies—not just at HHS but throughout the government—fixed terms of office whose expiration does not coincide with a presidential election year.
The legislation should also guarantee scientific judgments at agencies can not be overruled by political appointees. Government scientists should be given the right to speak publicly and publish their findings without prior restraint or political editing.
This is not a call for science uber alles. Congress still gets to decide what needs regulatory oversight when it comes to our food and drug supply, our air and water, and our workplace protections.
Agencies still have to give notice, allow comment and respond publicly when issuing rules and guidelines. Outside advisory committees will still serve as an additional layer of oversight and still be made up of independent scientists, members of the public and relevant stakeholders. But even here, some new laws are called for. Many scientists have financial ties to regulated industries, especially in the medical field. Current law merely calls for disclosure of such conflicts of interest.
The time has come for a total ban on individuals with ties to industry from serving on advisory committees. To encourage more independent scientists to volunteer for these oversight roles, and to increase diversity in their ranks, Congress should provide modest reimbursement—say about $20,000 or comparable to a drug company consulting fee—for their two-year terms.
Everyone wants the vaccine rollout to succeed. But for that to happen, the government must first restore trust in its public health agencies.
That mission will be greatly advanced by guaranteeing that power-hungry politicians and self-interested corporations will never again be allowed to override science in determining what best serves the public interest.
