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.
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.
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.
My hope is that a politically independent FDA would be much *more* likely to approve a EUA for a vaccine than the current one. The FDA right now, due to popular pressure, consistently makes mistakes in refusing to approve things that are safe and effective because it is too worried about backlash. It would gladly kill tens of thousands or hundreds of thousands of people from unapproved medicines to avoid hundreds of bad side effects. The FDA is *very* reluctant to approve medicines, which is why our approval process (even for sunscreen) is far slower than anywhere else, including everywhere that dealt with COVID-19 better. The FDA is purely horrified at the idea of at-home testing.
The FDA’s reluctance to approve things is ingrained in the body, but it is neither scientific nor ethical. It is politics, perhaps, but the popular unscientific fears are on the other side as Trump when it comes to vaccines (though not to testing, where Trump’s reluctance fits it well with the FDA’s natural reluctance.)
Perhaps a more truly independent FDA would help things, by making the FDA feel freer to approve things even when there is some risk of side effect, so long as the expected result is strongly positive. That’s what elsewhere in the world does, and why other countries, even European ones, will have a vaccine approved before the US.
The FDA made a blunder during the covid 19 test kits. They rejected the test kits applications made by other companies when CDC kits failed.
Trump push the FDA to make emergency approval of test kits.
So no, the FDA had proven that it cannot be independent. Otherwise it might drive our country to greater disaster with its rules and regulation that cannot bend to emergency and life and death situation. It is incapable of thinking and making judgment but only follow rules.
This argument feels backwards. First, the example of the risk of the Trump administration approving a vaccine early didn’t come to pass. If anything, it is an example that the system works. With an unconventional president in the middle of an intense reelection going around telling voters that the vaccine will be out soon, the FDA announced tough standards for an EUA that ensured that they won’t even consider an EUA until after the election. Heck, through all of this, the FDA has been one of the more conservative agencies. For example, keeping the AZ trial on hold weeks longer than its foreign counterparts.
Second, the real argument should be whether the FDA could be politically motivated to withhold a drug, because it has more power to halt a good drug than to push a bad one. The FDA is just one link in a chain of independent actors that have to accept the drug: manufacturer (including their lawyers)->FDA->insurance->doctor->patient. To the degree that the FDA is transparent, it would be readily apparent to all, whether the drug meets their individual safety and efficacy standards.
Third, as far as I am aware, the FDA does not have an independent enforcement function. It isn’t great practice to get yourself into the possibility of having a fight break out between the enforcement and regulatory functions. The current stalemate around marijuana, where it is illegal, but nobody is willing to enforce just begs for the creation of a black market and degrades respect for rule of law (please do not misunderstand: I am not taking a position on marijuana, just that the ban should either be enforced or repealed; an unenforced ban is the worst of all possible outcomes).
Fourth, like it or not, the FDA doesn’t deal exclusively in scientific questions. Science can tell you that a particular drug can cure a depression 99% of the time but cause blindness 1% of the time. It cannot tell you whether it is worth it. That is a value judgement which properly belongs in the political sphere and allowing politicians to hide behind: I didn’t do it, some board I don’t control did it, doesn’t do a service to voters.
Stiffly disagree with any move towards making the FDA independent of government oversight; this is from more than 30 years with of background having to deal with the FDA with regard to the review of medications necessary for the treatment and management of Digestive Tract Paralysis; if anything FDA has been too independent of government oversight and too much subject to the whims and vagaries of “public interest groups” such as Public Citizen; when government does not oversee groups like Public Citizen cause review decisions to not be based upon science, but rather the desires of consumer interest groups and at times class action litigators of the day.
If science was fully tied to FDA decision making in these cases, then drugs like Reglan would not have seen the light of day, see: https://www.drugwatch.com/reglan/ and drugs like Domperidone, developed specifically to better manage side effects would have, https://goldwaterinstitute.org/article/sickening-fda-bureaucracy-blocks-common-miracle-dr/.
You are right that science needs to control over FDA review; we fear who may hold sway over FDA oversight of government does not exert appropriate and measured control, review and the opportunity for patients and providers to be heard.