Cross-Posted on Notice & Comment
On April 18, 2026, President Trump issued Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” with the purpose of “increase[ing] access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.” The Executive Order, among other things, directs the U.S. Food and Drug Administration (FDA) to issue “Commissioner’s National Priority Vouchers to appropriate psychedelic drugs” and, with the Drug Enforcement Administration (DEA), to facilitate “Right to Try” access to ibogaine compounds and other psychedelic drugs. The Executive Order’s instructions for FDA are limited in some important ways, including leaving it to FDA to determine which psychedelic drugs meet the criteria, and are appropriate, for vouchers. At the same time, the Executive Order focuses on a specific group of products (psychedelics) and comes amid an alarming break with policies and strongly-held norms that previously limited political involvement in FDA’s decision-making about specific products. Against that background, this post considers what Executive Order 14401 directs FDA to do, how FDA has thus far responded, and how that compares with the ways in which Executive Orders have addressed FDA decision-making in the past.[1]
What Does Executive Order 14401 Tell FDA To Do (and What Has FDA Done So Far)?
Executive Order 14401 directs FDA to do three primary things, the first two of which involve programs that are controversial in their own rights (one established in this Administration, the other in the first Trump Administration) and are likely to receive the most attention. First, the Executive Order directs FDA to issue Commissioner’s National Priority Voucher (CNPV) program “vouchers”[2] to appropriate psychedelic drugs. The CNPV program is a new one. In June 2025, then-FDA Commissioner Marty Makary announced this program for drugs that “align with one of five critical U.S. national health priorities,” with the stated aim of shortening the time that FDA takes to review a drug application from 6 months for priority drugs to 1-2 months. Under the program, FDA decides whether a particular drug application meets the criteria for a national health priority such that it will receive this faster review process. Former FDA officials, lawmakers, industry, consumer advocacy groups, and scholars have raised a number of questions about the program, including about the legal basis and process for creating the program (e.g., the other voucher programs that FDA administers were created by statute, whereas the agency created this program via an announcement on the agency webpage without first issuing guidance or following any policy process); the program’s establishment of a new role for political appointees in initial drug approval decisions for products that receive a voucher; whether 1-2 months is enough time for FDA to carefully review safety and effectiveness data; what trade-offs FDA is making to devote the resources necessary to accomplish such quick review of certain products and what strains the program is imposing on a dramatically-diminished FDA workforce; and, perhaps most relevant to Executive Order 14401, that vague eligibility criteria for these vouchers potentially opens the door to political interference with FDA decisions about which drugs or drug companies are prioritized. Indeed, that FDA issued three vouchers for psychedelic drugs about a week after the Executive Order published has been cited as evidence that the CNPV program is susceptible to political interference.
The Executive Order also directs FDA and DEA to facilitate “Right to Try” access to ibogaine compounds and other psychedelic drugs. As with the CNPV program, “Right to Try” has its own backstory. After about 40 states passed “Right to Try” laws, in 2018 President Trump signed the federal “Right to Try” Act, which created a second, limited pathway for companies to distribute unapproved, investigational drugs outside clinical trials for treatment use, without first getting FDA authorization. The law created a second such pathway because, when it was enacted, there already was a pathway for this kind of distribution outside trials, known as “expanded access,” that involves FDA authorization and oversight. Particularly because FDA authorizes almost all expanded access requests and typically within a matter of hours or days, “Right to Try” is, according to many experts (myself included) and patient groups, at best a solution in search of a problem. Companies also choose to use it quite rarely, compared to expanded access. With at least one psychedelic company having successfully used expanded access to distribute investigational products outside clinical trials, it is curious that Executive Order 14401 declines to ask FDA to take any actions with respect to expanded access, the pathway with the far more substantial FDA role. Conversely, FDA, by statutory design, does not have a role in authorizing “Right to Try” programs and thus, at first glance, it may not be clear how FDA even could carry out Executive Order 14401’s instruction to facilitate such access. But Congress specified numerous criteria that must be satisfied for “Right to Try” to be an option, including that the relevant unapproved drug be the subject of an FDA-authorized Investigational New Drug (IND) application and a completed Phase 1 (i.e., first-in-humans) trial. And, about a week after the Executive Order was published, FDA announced that it authorized the first IND for an ibogaine compound to allow such a clinical trial to begin.[3] Under the Federal Food, Drug, and Cosmetic Act and FDA’s regulations, FDA’s decision on an IND is a product-specific one, which, at this early stage of drug development, is focused on safety (while at later stages FDA’s primary objectives also include assuring that trial design is sufficient to permit evaluation of effectiveness). The timing of FDA’s decision on this IND, coming both shortly after Executive Order 14401 and shortly after reports of what seemed to be a promise from the President to Joe Rogan that ibogaine would get approved, might give one pause about whether FDA’s decision was based on the scientifically-grounded statutory and regulatory criteria or instead was a politically-motivated one.
The third directive for FDA is to collaborate with the Department of Veterans Affairs (VA) “to increase clinical trial participation, data sharing, and real-world evidence generation about psychedelic drugs.” This collaboration is intended to “facilitate the timely evaluation and approval” of psychedelic drugs. From what is publicly announced, it seems that FDA has yet to take concrete steps related to this aspect of the Executive Order.
Finally, although not directed by the Executive Order, it is worth noting that FDA took a few additional psychedelic-related actions in July 2026. FDA finalized its guidance on clinical investigations using psychedelic drugs. FDA also announced a public meeting, to be held in September 2026, on the potential therapeutic uses of psychedelic drugs. (Anyone can request to speak at that meeting, if they submit the request by August 21, or submit a written comment by October 5.)
How Have Executive Orders Generally Addressed FDA Decision-Making?
As noted at the outset, the Executive Order does, on its face, preserve some key discretion for FDA decision-making. It does not, for example, say, “FDA will issue a CNPV voucher to Company X’s psylocibin product.” Rather it tells FDA to issue such vouchers to some psychedelics that the agency identifies as appropriate for them. One might wonder whether there is anything so unusual about an Executive Order commanding FDA to take such actions consistent with an Administration’s policy goals. FDA, after all, is an executive agency.
But based on a quick search of other Executive Orders, it does seem a bit unusual for an Executive Order to direct FDA decision-making. A search of federalregister.gov for Executive Orders with the phrases “Food and Drug Administration,” “Food & Drug Administration,” or “FDA” turns up 19 Executive Orders. The earliest is from 1999 and the most recent is Executive Order 14401. Of those 19 Executive Orders, 8 do not include directives related to FDA decision-making (e.g., they only mention the agency in a descriptive manner or as part of a multi-agency working group).[4]
That leaves 11 Executive Orders, including Executive Order 14401—across the 1300+ Executive Orders issued over the last 30+ years—that direct FDA to do something substantive. Of these 11 Executive Orders, 7 were issued by President Trump. Considering only the remaining 4 for simplicity and brevity, there is some precedent for Executive Order 14401. For instance, President Obama’s 2014 Executive Order, Combating Antibiotic Resistant Bacteria, directs FDA to coordinate with the U.S. Department of Agriculture (USDA) to “continue taking steps to eliminate the use of medically important classes of antibiotics for growth promotion purposes in food producing animals” and President Biden’s 2021 Executive Order, Promoting Competition in the American Economy, instructs FDA to work with the Federal Trade Commission to address efforts to impede generic drug and biosimilar competition. At a high level, neither of these is dissimilar to instructing DEA and FDA to work together to facilitate access to psychedelics via the “Right to Try” Pathway. As another example, President Obama’s 2011 Executive Order, Reducing Prescription Drug Shortages, provides that FDA, “to the extent practicable and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply,” will “take steps to expand its current efforts to expedite its regulatory reviews . . . whenever it determines that expedited review would help avoid or mitigate . . . drug shortages.”[5] This instruction, like commanding FDA to issue CNPV vouchers to appropriate psychedelics, involves FDA’s decision-making about how to prioritize application review and allocate its regulatory resources.
Yet there does seem to be something different about Executive Order 14401 in that it singles out a particular group of drugs and thus gets close to singling out particular drug companies or products. For example, while some drugs have more risk factors for going into shortage, any drug could be in shortage—and any drug potentially addressing a drug shortage would be treated the same under the relevant 2011 Executive Order. In contrast, although Executive Order 14401 mentions serious mental illness, it doesn’t direct FDA to prioritize that disease area or a public health issue, like drug shortages. Instead, it directs FDA to prioritize a specific set of products. Likewise, while directing FDA to collaborate with another agency on a policy priority has precedent, FDA authorizing an IND is supposed to be an application-specific decision grounded in the scientific evidence and the agency’s assessment of the adequacy of the trial design, not one made to advance policy priorities. If Executive Order 14401’s directive to FDA to work with DEA to facilitate “Right to Try” for ibogaine compounds is, effectively, a directive to authorize INDs for such products, that is concerning (though perhaps not as troubling as a directive to approve a specific product).
To be clear, this search was somewhat cursory and there are limitations. Documents from before 1994 are not word-searchable on federalregister.gov. There may be other search terms to include (e.g., certain directives to HHS may ultimately be carried out by FDA). There are other databases to search. I didn’t do a comparison with how frequently other agencies are mentioned in Executive Orders. Executive Orders are far from the only way that the White House directs agencies on its policy priorities. And so on. But, based on this preliminary search, Executive Order 14401 seems neither wholly unprecedented nor wholly aligned with how the White House has typically interacted with FDA in the past.
So What?
Mental illness is a serious public health issue deserving the government’s attention. Research on promising products, including psychedelics, should go forward so clinicians and patients will have the information they need to judge whether any given product is safe and effective. And there are developments involving FDA more worrisome than this Executive Order. But to the extent Executive Order 14401 tells FDA, even implicitly, to take certain actions on specific products, it is noteworthy.
What happens with one drug or class of drugs doesn’t happen in isolation—it can set a precedent that reaches beyond that specific drug, affecting the broader landscape of drug regulation and innovation. And, as Rachel Sachs and I discuss in an article on FDA independence forthcoming in the Utah Law Review, there is widespread agreement that scientific experts and scientific evidence, not political appointees and political considerations, should drive FDA’s product-specific decisions. Indeed, the FDCA requires that there is scientific evidence demonstrating that new drugs are safe and effective before they are marketed because patients need treatments that actually work, with benefits that outweigh the risks, not drugs that happen to be politically favored. Political meddling in drug approval decisions also poses risks for biomedical innovation, for which companies need predictability about how FDA will make evidence-based benefit-risk judgments to plan their research and development programs. It is perhaps for these reasons that Executive Orders appear to have been used infrequently to direct FDA decision-making and, even when they were used, they have generally steered clear of FDA’s decisions about specific products. (There could be other reasons for this infrequent use of Executive Orders as well—for example, a different Notice & Comment symposium explores, among other things, agencies’ roles in shaping Executive Orders.)
This is not to say there is no appropriate role for political involvement in FDA’s policy choices. There, of course, is. But Executive Order 14401 should be understood in the context in which comes: at a time when there is a high rate of political involvement in FDA decisions in ways that break longstanding norms that former career officials and political appointees from Republican and Democratic administrations have identified as critical for public health. In light of the ways those previous norms have served public health and innovation, it is important to identify when there are deviations from past practices and think carefully about whether those deviations are beneficial for FDA’s ability to satisfy its statutory obligations and for the patients whom FDA’s authority over drugs is ultimately designed to serve.
Thanks to Emma MacGuidwin of Ohio State’s Law Library for her expert research support, and Erika Lietzan and Rachel Sachs for their comments on an earlier version of this essay.
[1] This post was substantially drafted shortly after the May 2026 Conference on Psychedelics and the Law hosted by the University of Texas School of Law, with minor edits made in early August 2026.
[2] Although FDA is using the term “voucher,” the program does not involve vouchers that can be transferred, as the vouchers that Congress has created can. Rather, it involves a promise from FDA to review a company’s specific application on the faster timeline.
[3] At the time of the announcement, there were a few studies of ibogaine involving U.S. institutions already listed in clinicaltrials.gov as underway or withdrawn, though it may be that for all those studies the drug was obtained and administered outside the United States, without the need for an IND.
[4] Four mention FDA in a solely descriptive manner, such as to exclude FDA-regulated products from an Executive Order’s scope (here, here, here, and here). One lists FDA among many other agencies subject to a general labor policy (here). Two only provide for FDA participation in a multi-agency working group or advisory body. One directs agencies other than FDA to consult FDA when procuring certain products.
[5] The fourth executive order in this set is President Clinton’s 1999 order, Improving Health Protection of Military Personnel Participating in Particular Military Operations. This Executive Order pre-dates Congress creating the emergency use authorization pathway for medical countermeasures. It primarily instructs the Department of Defense (DoD) on how it may administer unapproved products, or approved products for unapproved uses, to military personnel, though it does instruct FDA on its role in reviewing DoD requests for waiving informed consent requirements.