Psychedelics Policy Newsletter: FDA prioritizes drug reform for psychedelics, Texas advances ibogaine research, and more

Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

• The FDA commission’s statement on psychedelics
• New psychedelics-related hire at HHS
• Roundup of state policies
• DEA permit for a church
• Meet with Reason Foundation staff in Denver

Research reform for psychedelics is a ‘top priority’ for the FDA

In an Interview with Jillian Michaels on NewsNation, Food and Drug Administration (FDA) Commissioner Dr. Marty Makary discussed psychedelics and clinical trial reform. “This is one of our top priorities at the FDA: to listen to doctors, to listen to patients, and to make sure we don’t get in the way with red tape,” noted Makary, referring to doctors who have seen positive results with psychedelics.

New psychedelics-focused hire at the Department of Health and Human Services

Attorney Matthew Zorn has been hired by the U.S. Department of Health and Human Services (HHS) as deputy general counsel and will reportedly be working on psychedelics-related reforms. Zorn has been active in psychedelics policy, including in a court case in 2021 attempting to require the Drug Enforcement Agency (DEA) to permit psilocybin-assisted therapy for a terminally ill patient. Though HHS Secretary Robert F. Kennedy Jr. has been vocal in the past on expanding access to psychedelics, his agency has not announced any major policy reforms. Zorn’s hiring signals that HHS may soon start working on policy changes that could impact psychedelic pharmaceuticals.

Additionally, on June 5, James O’Neill received enough votes in the Senate to be confirmed as deputy secretary of HHS. O’Neill has commented that drugs ought to be approved by the FDA based primarily on the agency’s review of safety data and that evaluations of “efficacy” could be completed after more patients have access to approved drugs.

Church gets DEA greenlight to administer ayahuasca

A Washington-based religious organization, the Church of Gaia, has reportedly been permitted by the Drug Enforcement Agency to administer ayahuasca in a ceremonial setting. Previous petitions have faced agency opposition. Soul Quest, for instance, needed to pursue its petition through lengthy court proceedings before it was ultimately denied by the DEA.

It is unclear if this signals a new approach to approving religious exemptions for the use of psychedelic substances under the Trump administration or whether Gaia approached the approval process differently. According to The Spokesman-Review, a DEA spokesperson said the agency will not disclose details of the petition but confirmed that the Church of Gaia “was among only a few churches that had or were nearing such approval.”

More state policy progress

There were significant wins for psychedelics reform at the state level this spring. The Texas legislature appropriated $50 million for grants to study the medical applications of ibogaine through FDA-supervised clinical trials. Gov. Greg Abbott signed the appropriation, Texas Senate Bill 2308, into law on June 11. Ibogaine has shown tremendous promise as an alternative treatment for opioid use disorder. Reason Foundation provided testimony in support of the study bill.

Next door to Texas, New Mexico became the first state to legalize psychedelic services through a state legislature (instead of a ballot measure). Read more about state-level reform in our state roundup.

Come meet Reason Foundation’s drug policy team

Reason Foundation Vice President of Policy Len Gilroy and Research Director Geoff Lawrence will speak at this week’s Psychedelic Science Conference in Denver, Colorado. Come say hi to the drug policy team at this large gathering of professionals in the psychedelics industry.

The post Psychedelics Policy Newsletter: FDA prioritizes drug reform for psychedelics, Texas advances ibogaine research, and more appeared first on Reason Foundation.