Trump promotes psychedelic drug availability but legal issues remain

In an Executive Order (EO) signed on April 18, President Trump directed three key actions aimed at spurring psychedelic drug development:

• The Food and Drug Administration (FDA) must issue Commissioner’s National Priority Vouchers (CNPVs) for appropriate psychedelic drugs that have received breakthrough therapy designations and meet CNPV program criteria.
• FDA and the Drug Enforcement Administration (DEA) will “facilitate and establish” a pathway for eligible patients to access psychedelic drugs under the Federal “Right to Try Act.”
• The Attorney General, in consultation with HHS, will begin product-specific Schedule I review after the completion of a successful Phase 3 trial for that product.

The only specific psychedelic substance named in the EO is ibogaine, a West African naturally derived product seen as a potential treatment for opioid dependence, depression, and anxiety. Speaking at a press conference on the EO, FDA Commissioner Marty Makary announced the agency would issue priority review vouchers to serotonin 2a agonists, a class that covers psychedelics such as LSD and psilocybin. Then, six days after the press conference – in compliance with the EO – FDA announced it is issuing three CNPVs to companies studying methylone for post-traumatic stress disorder (PTSD), and psilocybin for treatment-resistant depression and for major depressive disorder. FDA also said it is permitting an early phase clinical study of noribogaine hydrochloride (an ibogaine derivative) to treat alcohol use disorder to move forward, following an IND submission.

The EO also directs of the Department of Health and Human Services (HHS) to allocate at least $50 million from existing funds to support and partner with state governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses. The EO further orders HHS to collaborate with the Department of Veterans Affairs and the private sector to maximize enrollment in clinical trials testing psychedelic study drugs.

Right to Try

The Federal Right to Try Act provides patients with life-threatening conditions who have exhausted approved treatment options the ability to seek treatment using investigational drugs that are still in clinical trials. The Federal Right to Try law creates a parallel pathway that can be used – where applicable – in lieu of FDA’s Expanded Access program. Importantly, before a drug is eligible to be used under Right to Try, a Phase I trial must have been completed of the drug, and the drug must either be (a) the subject of a pending marketing application, or (b) under investigation in an active pivotal trial. Although some states have broader Right to Try legislation, the Federal law still requires that a condition be “life-threatening,” and many “serious mental illness” conditions for which psychedelic drugs may be used may not meet the “life-threatening” criteria. The EO aims to remove these barriers, which have kept Right to Try from being available to psychedelic therapy candidates, but does not amend the Right to Try Act.

We also note that although the EO raises Right to Try as a means to access psychedelic drugs, it does not exclude parties from instead utilizing FDA’s Expanded Access pathway (sometimes referred to as "compassionate use”). FDA’s Expanded Access regulations provide another pathway for patients who have serious or life-threatening diseases to gain access to investigational drugs, biologics, or medical devices outside of clinical trials.

Controlled Substances Act

The EO’s directive to the Attorney General to initiate rescheduling review upon the completion of a successful Phase 3 trial is generally consistent with the CSA, although it remains to be seen how DEA and HHS will define a “successful Phase 3 trial” in this context. The statute does not require completion of a Phase 3 trial as a trigger for Schedule I review, but allows the Attorney General (delegated to DEA) to initiate scheduling or rescheduling at any time. In practice, scheduling review is typically initiated very late in the application review process, which can delay product availability. The EO appears designed to address this pacing issue by requiring the Attorney General to begin rescheduling review earlier.

Next steps

Details on the implementation of the EO remain thin as neither the EO nor the accompanying Fact Sheet specific formal deadlines for FDA, DEA, or HHS to act. However, qualifying psychedelic drugs are immediately eligible for CNPVs and may represent the area where developments emerge most quickly. FDA pledged to “imminently” issue final guidance to support sponsors of psychedelic therapies, saying it will issue “recommendations related to study design, data collection and generation, patient monitoring and conducting adequate and well-controlled clinical investigations.”

Taken together with other recent statements by leaders of the Trump administration, we see the EO as favoring psychedelic therapy companies with late stage medical products, particular for those targeting “serious mental illness” and veteran populations where unmet need is high—especially taking into account the unprecedented nature of an EO to permit expedited regulatory review of a specific category of drugs.

If you have any questions on psychedelic therapy development, the CNPV program, or regarding clinical trials and FDA approval standards more generally, please feel free to contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Elizabeth Jungman, Heidi Gertner, Robert Church, and Stephanie Agu