Public health experts and lay observers alike have expressed concerns that, under political pressure, the Food and Drug Administration will prematurely approve an emergency use authorization (EUA) for a Covid-19 vaccine even if the data do not support it. The FDA has pushed back against this possibility.
But the reality is that if the Trump administration has the political will, it can overturn the FDA’s preferences.
The FDA is one component of the Department of Health and Human Services. And by constitutional design, the secretary of health and human services is not independent of the president. If the American people want the FDA to be independent, they need to pressure Congress to make some changes.
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The authority to make decisions on both drugs and vaccines is delegated to the HHS secretary. So is the authority to issue an emergency use authorization. For drugs — but not vaccines — the secretary must exercise these powers through the commissioner of the FDA. The line of authority is clear: The HHS secretary oversees the FDA commissioner and is the one responsible (and, by implication, in charge). Both the FDA commissioner and the HHS secretary are removable at will by the president. Removing either because the president dislikes their policy choices is legal, if not always politically or substantively wise.
As a member of the president’s cabinet, the HHS secretary is expected to represent the president he, she, or they serves. Under long-standing principles of administrative law, the secretary’s decisions, including those made “through the commissioner,” need to be justifiable in court as consistent with law, compliant with legally required procedures, adequately supported by evidence, and not arbitrary or capricious.
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But when it comes to policy, the secretary is a political actor accountable to the president and, like all cabinet members, is expected to be the president’s person. This is how our system is designed.
In practice, throughout its 114-year history, the FDA usually — although not always — has been allowed by the HHS secretary and the president to exercise its independent judgment. But this has reflected the belief of successive secretaries and presidents that the public health and welfare are best served when the kinds of decisions the FDA makes are based on scientifically established facts and reflect expert science-based judgment, not perceived short-term political gain. It But that deference is not required.
To create an FDA independent of the HHS secretary, the public’s representatives in Congress — and the president — need to change the governance of the FDA. As a first step, the laws governing the FDA’s authorization of drugs and vaccines could be changed to make the FDA commissioner the decision maker, rather than the HHS secretary. Congress could also add more specific criteria for issuing an emergency use authorization for a vaccine or drug — criteria already exist for approval of both drugs (which must be “safe and effective”) and vaccines (which must be “safe, pure, potent and effective”).
Criteria for an emergency use authorization would have to account for the emergency nature of the measure, and the harms from slowing access in a real emergency, but the experience with Covid-19 may suggest we need to rethink the current balance between speed and limits.
Congress could also restructure the FDA’s leadership into a multi-member commission protected from removal. Several independent agencies follow that model, such as the Federal Trade Commission and the Federal Communications Commission. The Federal Reserve Board does, too, and I have previously recommended adopting its structure for strengthening the Centers for Disease Control and Prevention’s institutional independence. Under existing Supreme Court jurisprudence, adding removal protections for a single head of an executive agency — like the FDA — is likely unconstitutional. But a multi-member board can — and traditionally has, in our system — enjoyed such protections. Such a measure would increase the FDA’s independence, but will have costs, such as slowing decision-making.
The American people could also make it clear, directly or through their elected representatives, that they expect their elected administration to respect the FDA’s independence.
The FDA was not designed to be independent. Maybe it is time to discuss whether it should be.
Dorit Rubinstein Reiss is professor of law at the UC Hastings College of the Law and a member of the Vaccines Working Group on Ethics and Policy.
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November 03, 2020 at 05:02PM
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Is it time for the FDA to become an independent body? - STAT
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