Keeping Up with the Feds: From FDA to HRSA, Washington Backs Psychedelics

This morning, FDA issued its final guidance on psychedelic clinical investigations and announced a September public hearing “on the potential future therapeutic use of psychedelic drugs” and an associated request for comments. (We provided a detailed breakdown of the final guidance, as well as coverage of the planned hearing, in our Pα+ article: FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies.)

Then, this afternoon, HHS and VA announced that they have entered into a five-year Memorandum of Understanding (MOU) “to strengthen collaboration on the research, clinical development, and responsible deployment to veterans suffering from serious mental health conditions of potential future rapid-acting psychedelic drug products if approved by the Food & Drug Administration.”

The press release featured quotes from various agency and Department leaders, including VA Secretary Doug Collins, who said that Trump has “opened up a world of possibility for treating Veterans and others with mental health conditions, and VA is proud to be part of this important work”, and that the MOU “ensures effective cooperation with HHS as we try to turn research into life-changing treatment.”

More specifically, VA and HHS say that they will work to increase trial participation, train clinicians in preparation for approvals, collect and share real-world data on safety, effectiveness, and costs, coordinate research and evidence sharing, and develop clinical guidance and educational resources for providers.

A second MOU between FDA and VA contemplates an expansion of “information-sharing and scientific collaboration” between the pair, “to help advance the development and evaluation of innovative therapies for serious mental illnesses.”

Elsewhere, the release shares that NIDA “recently revived and validated data from earlier ibogaine studies and shared those data with the FDA and researchers to help inform the drug’s ongoing scientific and regulatory evaluation.”

It was also revealed that NIDA has awarded funding to a multi-phase ibogaine research project that will work toward securing investigational new drug (IND) clearance, which would unlock the first trials of the drug on American soil. (More to follow for our Pα+ readers.)

If that comes to pass, NIDA hopes that trials will be able to answer whether “updated dosing and administration approaches” can manage the risks associated with ibogaine without compromising its therapeutic potential.

ARPA-H, meanwhile, is also carving out funds for ibogaine-related work. It has invited companies and academics to bid for funding to study the drug for opioid use disorder. “Funding will support early clinical development and preparation for FDA review,” the announcement states, “while also exploring ways to keep future treatments affordable and accessible.”

Lastly, HRSA will tomorrow issue a request for information that seeks input on how America’s healthcare infrastructure should prepare for the potential roll-out of psychedelic therapeutics, if approved.

Specifically, it seeks recommendations related to “clinician education and training, evidence-based care delivery models, and approaches for safely delivering these therapies in community-based settings”. That input will apparently help inform HRSA’s future guidance and technical assistance.

It’s a lot to keep track of, so here’s a simplified list of today’s announcements:

• FDA issues final guidance for clinical investigations of psychedelics
• FDA announces September psychedelics public hearing and associated request for comments
• HHS and VA enter into MOU covering research, clinical development, and potential deployment of psychedelics to veterans
• FDA and VA enter into MOU covering information sharing and scientific collaboration
• NIDA awards ibogaine funding
• ARPA-H announces competitive ibogaine for opioid use disorder funding opportunity
• HRSA issues RFI pertaining to healthcare infrastructure readiness

For its part, FDA has now set up a dedicated webpage to feature its efforts in this realm. It says that it “has made significant advances in psychedelic drug development”. It’s coming thick and fast, now: three of the four actions it highlights on that webpage were announced today alone.