The Covid-19 pandemic has turned obscure regulatory bodies into front-page news. Among these is the Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee, the group that reviews the safety and effectiveness of vaccine candidates and then makes recommendations to the FDA about whether to authorize and license vaccines.
The committee meets on Thursday to discuss the development of Covid-19 vaccines, including where the scientific evidence currently stands and possible timelines for vaccine Emergency Use Authorizations or approvals. The FDA will publicly livestream the proceedings, and I think that all Americans should tune in. This FDA hearing can help increase trust in regulators, refocus attention on Covid-19 science and away from Covid-19 politics, and demonstrate that sound governmental processes persist even in the face of partisan pressures.
The FDA is the world’s most powerful regulatory body largely because of its longstanding reputation for competence. Watching the agency at work can help bolster the public’s faith that 2020’s abnormal politics have not destroyed normal governance. Observing experts reviewing evidence while following a robust set of standard procedures should serve as an important reminder that dedicated public health experts and officials, and not presidential tweets, sit at the core of the public policymaking process in the United States.
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It is a signal of some health in our governing institutions that amid intense political pressures, previously obscure officials like the FDA’s Peter Marks, bodies like the Vaccine and Related Biological Products Advisory Committee, and procedures like Emergency Use Authorizations, are central to public conversations.
The 20-person advisory committee includes 17 non-FDA experts who are based at academic medical centers, public health organizations, advocacy groups, and companies. Their expertise ranges from infectious diseases and pediatrics to biostatistics and health law. The FDA follows the recommendations of such committees, which aren’t binding, about 80% of the time.
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By drawing on external authorities to advise internal regulators, and by including patients or their representatives, scientists, and firms, FDA advisory committees can merge expert guidance with public accountability and transparency. Hearing directly from this diverse, representative, and authoritative body can help increase the public’s trust in government regulators and the products they authorize, including future Covid-19 therapeutics and vaccines.
Thursday’s FDA hearing also provides an opportunity to amplify the voices of independent expert scientists, and to refocus attention on data and evidence and away from politics and partisanship.
From the FDA’s Emergency Use Authorization of hydroxychloroquine in March and its June revocation of it, to President Donald Trump at a campaign rally in Nevada mocking Vice President Joe Biden’s intention to “listen to the scientists,” the politicization of science stands among the pandemic’s many casualties. Given that politics and partisanship have already played large and problematic roles in deliberations about Covid-19 vaccines and therapeutics, it is essential to reduce the politicization of science. The FDA hearing on Thursday of its vaccine advisory committee can help counteract this worrisome trend by focusing collective attention on the evidence and on the science.
More generally, Thursday’s meeting should help demonstrate that sound governance and competent policymaking persist even when under the serious threat of nonexpert political meddling.
To be clear, none of the benefits of Thursday’s proceedings turn on whether the evidence of the safety and effectiveness of Covid-19 vaccines are strong or weak, or whether the committee suggests that the president will or won’t get the swift authorizations and approvals he seeks.
Independent of the outcomes, it is the process itself and the experts behind it that can engender trust. If the committee suggests that the existing evidence should quickly yield safe and effective vaccines, Democrats should trust that determination. Likewise, if it suggests that more testing is needed to yield safe and effective vaccines, Republicans should trust that assessment.
Of course, many regulatory decisions are combinations of policy and politics, and it would be implausible to suggest that decisions about Covid-19 therapeutics and vaccines are any different. But the FDA’s vaccine advisory committee’s public deliberations on Thursday can raise the salience and weight of the policy side of the ledger. Its livestreamed discussion should help ensure that science, expertise, and sound regulation will win out over politics and partisanship.
Herschel Nachlis is a research assistant professor of government and a policy fellow at the Rockefeller Center for Public Policy, both at Dartmouth College.
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October 22, 2020 at 04:01AM
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Watching this FDA hearing can help ease your Covid-19 anxieties - STAT
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