The FDA announced a public hearing to gather feedback on the potential future therapeutic use of psychedelic drugs in supervised treatment settings.

The hybrid hearing will be held on September 14, 2026, from 12:30 PM to 4:30 PM EST. Registration must be completed through the meeting registration page. All requests to present at the hearing must be received on or before 11:59 (sic) ET on August 21, 2026. Written comments may be submitted to the Federal Register :: Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments electronic filing system on or before 11:59 PM ET on October 5, 2026.

Ongoing psychedelic research and regulatory activity on state and federal levels could influence future treatment options for injured workers with PTSD and other behavioral health conditions, particularly among first responders and other high-risk occupations.

This new hearing aligns with the current Administration’s focus on advancing research into innovative treatments for serious mental health conditions, including post-traumatic stress disorder (PTSD), depression, and substance use disorders, while maintaining FDA standards for safety and effectiveness.

Although no psychedelic drug products have been approved by the FDA for general medical use in therapeutic settings, research activity in this area has increased in recent years.

The FDA recently finalized guidance information for clinical trials, three years after issuing an initial draft that underwent much review and public discussion. Additionally, the FDA issued priority vouchers in April to three companies developing drugs based on psychedelics; one to a company studying psilocybin for treatment-resistant depression; one to a company studying psilocybin for major depressive disorder, and another to a company studying methylone for PTSD.

From 2017-2019, the FDA granted Breakthrough Therapy Designation, which speeds development of potentially significant new treatments, to investigational psilocybin therapies for depression and MDMA-assisted therapy for PTSD. Later in 2024, the FDA declined to approve the first New Drug Application for MDMA-assisted therapy for PTSD, citing the need for additional evidence on safety and effectiveness and concerns regarding aspects of the clinical trial data.

All of this is particularly interesting as two recent psychedelic clinical trials announced positive results from Phase III clinical trials, the state prior to an FDA drug submission.

One trial for DT120, a pharmaceutical formulation of lysergide (LSD) tested for the treatment of major depression, demonstrated significant improvements in depression. The drug was well tolerated in patients, out-performing Spravato, an FDA-approved formulation of ketamine, which is used for the treatment of severe and hard-to-treat depression.

One trial for COMP360, a pharmaceutical formulation of psilocybin tested for the treatment of chronic treatment-resistant depression, found the drug resulted in clinically meaningful reductions in depression scores, which were maintained at the 26-week mark. The drug was well tolerated, and FDA review is already underway. Drug developers believe a commercial launch could happen as soon as the first half of 2027.