Can Trump Order the FDA to Approve a Treatment for Unscientific Reasons?

Editor’s Note: Lawfare is not a public health law site, and normally, we would not run a piece on food and drug law and the authority of the FDA. This post, however, involves a matter core to Lawfare’s concerns: the authority of the president to direct the conduct of a federal agency in apparent defiance of clear statutory language.

Over the past several months, President Trump has claimed repeatedly that a novel coronavirus vaccine could be made available before the 2020 presidential election. All along, vaccine experts have thought this timeline very unlikely, and the recent release of information about the design of some of the most promising vaccine candidates confirms that trial results will likely come, at the earliest, later in the fall.

The U.S. Food and Drug Administration (FDA) has expressed openness to a possible Emergency Use Authorization (EUA) for a coronavirus vaccine. The statute permitting EUAs was enacted as part of the Project BioShield Act of 2004 to enable the U.S. Department of Health and Human Services to quickly authorize the distribution of unapproved medical products (including drugs, vaccines and therapeutics) in the event of a public health emergency. The department has long delegated authority to issue EUAs to the FDA. Ensuring that the FDA and Health and Human Services exercise their EUA authority responsibly and free from political interference is critical to ensuring public safety. Consider the current crisis. Any errors in authorizing a treatment or vaccine for the novel coronavirus could have serious repercussions for the United States’s ability to get the pandemic under control, and for health security more broadly. Recognizing the importance of reaching a scientifically sound decision on issuing an EUA for a coronavirus vaccine, the FDA recently set forth in draft guidance the evidence it will require for such a step. When read with the trial designs, it is now almost certain that a vaccine could not be authorized before the election.

In September, Trump castigated the FDA for its approach, and he and his political appointees initially blocked the FDA’s release of its draft guidance. Then, on Oct. 7, two days after the president returned to the White House after being hospitalized with COVID-19, the respiratory disease caused by the novel coronavirus, he tweeted a video message in which he acknowledged receiving Regeneron’s experimental antibody cocktail. He then suggested that he has already personally intervened, or might do so, in the FDA’s consideration of whether to issue an EUA for the Regeneron therapeutic—which is still the subject of clinical trials—because he “felt good immediately” after taking it and because it “was the key” to his returned health.

The politicization of the race to approve safe vaccines and therapeutics for the novel coronavirus raises significant dangers to the public and serious legal questions. Could the president or the secretary of Health and Human Services legally direct the FDA to issue an EUA based on an unscientific belief in the medical product’s effectiveness, or with an intent to influence an election? The short answer is no. Though Congress granted Health and Human Services broad discretion to issue EUAs, it also established clear standards, requiring that emergency authorizations be issued only on the basis of “scientific evidence” and for the purpose of protecting public health. A decision by the president or the secretary of Health and Human Services to issue an EUA on the basis of unscientific claims, or for a different reason, would exceed their authority, and would be illegal and illegitimate.

The enforcement of these standards will, however, likely rely in the first instance on FDA officials and scientists themselves. While there are avenues that could theoretically allow courts to invalidate a political or unscientific grant of an EUA, there is little case law to rely upon. Litigation likely offers a plausible remedy only in cases where the improper nature of the grant is quite obvious. The first line of defense, in all probability, is that the secretary and all federal employees at the FDA have sworn an oath to uphold the Constitution. To fulfill that oath, and to protect the public trust and the agency’s reputation, they must insist that all authorizations or approvals of vaccines or therapeutics follow the scientific, public-health-justified process set forth by Congress.

Legal Standards

Under ordinary circumstances, a manufacturer seeking FDA approval of a vaccine or therapeutic would need to disclose the product’s contents to the agency and demonstrate its safety and efficacy with data from three increasingly rigorous stages of clinical trials, which are generally conducted over the course of several years. Even then, the FDA might approve a product only on the condition that it undergo postapproval studies to learn of potential risks or benefits not discovered during earlier trials.

Congress has also provided Health and Human Services with authority to issue EUAs for vaccines and therapeutics in extreme public health emergencies. The issuance of an EUA allows a manufacturer to begin distributing its product immediately, though the decision is not a full approval, and it also can be conditioned on the completion of further studies. But even in public health emergencies, Congress did not grant the department unbounded discretion to issue EUAs. Instead, Congress set statutory conditions that must be satisfied before the department is empowered to issue an EUA. Two such conditions are relevant here.

First, the secretary of Health and Human Services must “make a declaration that the circumstances exist justifying an [emergency] authorization … on the basis of” a determination by the secretary that there is an emergency threat to public health. Secretary Alex Azar has previously and appropriately […]

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