Beyond Psychedelics—What Executive Order 14401 Signals for Drug Regulation and Innovation

Published on by Patti ZettlerLeave a comment

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.

What Now?

Published on by Erika LietzanLeave a comment

This is the second in a series of posts on food and drug law scholarship posted to SSRN from January to June 2026.   The 1980s were my decade, and as I read these three pieces, the lyrics to Once in a Lifetime started — and then would not stop — in my head.  They consider … where we find ourselves. 

You may ask yourself, “Where does that highway go to?”
And you may ask yourself, “Am I right, am I wrong?”
And you may say to yourself, “My God, what have I done?”

(Same as it ever was?  Maybe a little bit. See below.)

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Food, Drugs, and Classification Issues

Published on by Erika LietzanLeave a comment

This is the first of a series of posts on scholarship related to food and drug law posted on SSRN in the first half of 2026.  The two pieces below share a topic — the significant difference between regulation as a food and regulation as a drug — and circle around a common question: why do we ask certain things (before market entry) of the one, and not the other, and does this always make sense?

Whose Burden Is It Anyway?

(Subtitle: A Comprehensive Proposal to Reshape Food Safety Review by Treating Food as Medicine.)

The title of this piece, authored by Katya Cronin of GW Law and published in 2025 in the American Journal of Law & Medicine, gave me the (incorrect) impression it would talk about the blurred line between foods and drugs and perhaps even propose reclassification of some (or all) food as medicine.  Instead, it is very solidly grounded in the real world —  with a succinct and clear description of current regulatory requirements with respect to the safety of food ingredients [which she defines to include unintended environmental contaminants], and then detailed suggestions for both Congress, and FDA, to make the food regulatory paradigm much more rigorous with respect to ingredient safety.

What Congress should do. Ultimately, she argues that (1) Congress should eliminate the GRAS carve-out from the food additive definition, or in the alternative limit its application to substances that have at least twenty years of use, and at the very least mandate submission of GRAS certifications to the agency; (2) eliminate the food contact notification program in favor of a full premarket petition process and clarify that the Delaney Clause applies with equal force, and without de minimis exception, to GRAS substances as well as all direct and indirect food additives and food contact substances; (3) enact user fees for all food-related premarket submissions; (4) require clinical studies for any new food or color additive; and (5) authorize FDA to require more extensive reporting from food manufacturers. 

What FDA should so. In the meantime, and even if Congress fails to act, she argues that FDA can and should take numerous steps on its own.  For instance, she says, it should convert the voluntary GRAS notification system to a mandatory notification system and issue guidance stating that novel substances cannot be subject to GRAS determinations.  She also argues that the agency should “enforce in practice the manufacturers’ legal burden of proving safety.”  Thus, she says, it should  “examine all filed GRAS notices and approved food and color additives and should summarily revoke those that are filed without sufficient toxicology, feeding toxicity, and other relevant data.”  It should use artificial intelligence to identify approved additives as to which there are “reputable, peer-reviewed studies with adverse safety results,” she says, arguing that “the very existence of such studies should sufficiently demonstrate that the manufacturer failed to demonstrate reasonable certainty of safety.”  Third, she says, FDA should require food manufacturers to test “every lot” for heavy metals, environmental toxins, and pathogens.  And finally, she argues that FDA should require that all food and color additives be listed on food labels and that the manufacturer’s labeling information (on their website or otherwise available) contain data on the relevant safety testing that supports the determination that the ingredient is safe for use.

Striking while the iron is hot? Most of these proposals are not, I think, new to food policy circles, but they are helpfully gathered here and stated clearly and precisely.  I think there is more to say about the proposals specific to FDA  — in terms of resource availability and options, as well as potential legal constraints — but that would be (perhaps is?) another article.  This is a helpful “gather everything together and start the conversation” piece.  And she has framed this to be exceptionally timely, borrowing from the “food is medicine” zeitgeist (and the observation that “medicine” has much more rigorous safety requirements), and pointing to political momentum to reform the food system. 

As the next piece suggests, though, a more drug-like paradigm would have its costs…

When Food Becomes A Drug

This one, also, was not about the blurred line between food and drugs!  (I’ve been thinking about Lewis Grossman’s article, Food, Drugs, and Droods, as well as FDA’s famous warning letter to General Mills about its Cheerios being a new drug on account of something printed on the cereal box.) 

A new animal drug application … for my grilled salmon. Instead, this article — written by Hadar David, a doctoral candidate at Stanford Law School — concerns itself with genetically engineered food animals, such as AquAdvantage Salmon, which was genetically engineered to grow more quickly than its Atlantic salmon counterpart and approved by FDA in 2015.  And to be clear about the regulatory treatment: this required approval of a new animal drug application (NADA).  David writes, “although food products from GE animals are intended for consumption as food, they are regulated not as food but as drugs, triggering a premarket approval process that involves rigorous and time-intensive data requirements.” (And, both are true. Genetically modifying the salmon in the first instance requires approval of an NADA, but the food product made from the salmon is still regulated as a food. Thus, as FDA explained in a Q&A at the time, USDA would regulate the disclosure of bioengineered content on the labeling of any human food made from the GE salmon.)

Bad for innovation. Part III of David’s article argues that application of the drug paradigm to GE food animals “has had a profound impact on both industry and academic stakeholders.”  Specifically, he says, it has had two deleterious results: (1) “the complexity, cost, and duration of the FDA’s drug approval process have significantly narrowed the field of actors willing or able to engage in GE food animal development,” and (2) “the scope of innovation has been curtailed: regulatory burdens have led to a concentration on a limited number of commercially viable traits, while more experimental or socially beneficial applications remain unexplored.”

Is it really a “drug”? A short section in the middle of this article evaluates FDA’s classification of genetic modifications in GE food animals as “drugs.”   David concedes that courts are unlikely to take into account the policy implications of the classification.  And he notes there are questions about who could (and would) seek judicial review.   But he nevertheless takes up the basic issue, making an argument from the statutory text and legislative purpose that the agency’s interpretation is problematic.  In the end, this argument is unlikely to prevail, and I think he realizes that.  In 2019 — as he notes — a district court in the N.D. California upheld FDA’s authority to regulate the (GE salmon) product.  This was Institute for Fisheries Authorities v. Hahn, 424 F. Supp. 3d 740 (N.D. Cal. 2019).   The court agreed that FDA can treat the recombinant DNA “construct” used to modify the animal as a “drug” because it is intended to affect the structure or function of the animal.  It may also be worth noting that the court reached this conclusion without applying the Chevron framework; i.e., it decided without much fanfare that the plain language of the statute answered the question — placing the construct within the term “drug.”  Consequently there is no reason to think a court would come out differently now, with Chevron overruled.  (And I think some of the arguments in that case were similar to those David offers.)

In search of a better approach. But the heart of David’s argument is more philosophical.  He’s concerned about the policy implications of the classification, and I think also bothered by the basic conceptual difference between modifying an animal for therapeutic purposes and modifying it for food production purposes.  (One could devote an entire article to this — going back to the old question of how to cabin the structure/function prong of the drug and device definitions — but that is a different article.)  In any case, he argues that the complexity of the subject, and the need to consider the broader consequences of the classification chosen, mean the courts are not the right place to turn for a coherent long-term framework.  To be sure! 

Section V then discusses non-drug alternatives (as a food? as a food additive?) before settling on new legislation, which he proposes would take lessons from Argentina and Brazil in particular.  I trust, and hope, this can be fleshed out in a subsequent article in greater detail, but the idea seems to be making some basic distinctions — such as between transgenic modifications (introducing genes from another organism) and non-transgenic alterations (such as knock-out situations), though he notes that this categorical distinction might not correspond to actual risk.  It would be very interesting to see this fleshed out, perhaps in another article. 

Artificial Intelligence & Machine Learning: Recent Scholarship

Published on by Erika LietzanLeave a comment

As FDA has noted, artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare. These technologies could be used at the agency, by other agencies involved in healthcare regulation and finance, by private participants in the healthcare delivery system, and by medical device manufacturers. They can also be embedded in conventional medical devices or, indeed, serve as standalone medical devices. For several years now, FDA has been exploring how its existing medical device framework applies, or should be adapted to apply to, software “as” a medical device as well as software “in” a medical device. In this post, I review four recent law review articles exploring legal and policy issues presented by the emergence of artificial intelligence and machine learning in medical devices and the healthcare setting more generally. 

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Recent Scholarship: FDA and Other Regulators

Published on by Erika Lietzan1 Comment

As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulators. Both, I think, reflect the same notion; as Professor Tammi Etheridge (who writes the second article) says, this work “belies the notion that all agency collaboration is good collaboration.” 

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The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try

Published on by Erika Lietzan1 Comment

This note explains some of the concepts swirling around in the media right now, relating to medicine approval. Much of what follows appears (or will appear) in an article on the U.S. “right to try” law, which I recently wrote with a colleague at the University of Bourgogne in Dijon, France.  Some of the background discussion will be useful here.

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Vaccine Approval 101

Published on by Erika LietzanLeave a comment

Here’s a tutorial on the usual process for vaccine development, testing and approval, for folks tracking the new coronavirus (COVID-19).  In brief: it will take a while and very large clinical trials to get a coronavirus vaccine approved at FDA. But preapproval testing is likely to happen on the ground where the coronavirus is spreading, and there is a potential for expanded access (to the unapproved vaccine) in the meantime.

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Emergency Use Authorizations

Published on by Erika LietzanLeave a comment

Here’s a quick tutorial on the “emergency use authorization” (EUA) process at FDA, for folks following the coronavirus.  This explains in a little more detail the information that Dr. Gottlieb posted in a Twitter thread earlier today. 

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SSRN Reading List . . . or Device Regulation: What Role for Tort Law?

Published on by Erika Lietzan2 Comments

The 2020 annual conference of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (at Harvard Law School) will focus on the future of medical device regulation.  If you’re interested in participating, abstracts are due on October 14, final papers are due March 27, and the conference is May 8.  (Here’s a link to the call for papers.)  I’m working on an empirical project relating to device premarket approval and patent term restoration, but sadly the dataset won’t be ready in time.  Meanwhile, here’s a run-down of some interesting legal scholarship on medical device regulation in the last year and a half. 

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FDA’s Abandoned Proposal to Require Reporting of Data Falsification

Published on by Erika LietzanLeave a comment

On August 6, FDA announced that Novartis’s application for approval of Zolgensma contained “manipulated” data and that the company knew this while the application was pending, but did not tell the agency.  Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.”  It may be helpful to review the concerns that people raised.  Details after the jump.

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