We remain committed to ensuring that Veterans and others living with treatment-resistant mental health conditions have access to safe, evidence-based care. We respectfully urge the FDA to continue its evaluation of entactogen- and psychedelic-assisted therapies with transparency, urgency, and scientific rigor as the agency carries out its statutory responsibilities.
Ensure veterans and others with treatment-resistant mental health conditions have access to safe, evidence-based care, including continued FDA evaluation of entactogen- and psychedelic-assisted therapies with transparency, urgency, and scientific rigor.
Occurrences
Evidence
People reported in the last lookback window that former Navy SEAL Marcus Capone and VETS have helped fund treatment for nearly 1,300 ex-military personnel and are campaigning to legalize and research ibogaine further in the U.S.; the article describes ibogaine as illegal in the U.S.
AP reported that President Trump signed an order accelerating federal reviews of psychedelic drugs, including ibogaine, and that FDA would issue fast-track national priority vouchers for three psychedelics while human trials of ibogaine were set to begin in the U.S.
The Washington Post reported that Rep. Lou Correa co-founded the Congressional Psychedelics Advancing Therapies Caucus, that lawmakers in both parties were working on legislation to boost the field, and that FDA priority vouchers went to companies studying psilocybin for depression and methylone for PTSD.
FDA issued draft guidance to sponsors developing psychedelic drugs for medical conditions including psychiatric and substance use disorders; FDA states the term includes classic psychedelics such as psilocybin and LSD and entactogens/empathogens such as MDMA.
FDA convened a public advisory committee meeting on new drug application 215455 for midomafetamine (MDMA) capsules submitted by Lykos Therapeutics for PTSD, with discussion of benefit-risk profile and a public comment docket.
AP reported that an FDA advisory panel voted against MDMA for PTSD, citing flawed study data, research misconduct, safety risks, lack of follow-up data, and lack of demographic diversity.
Assessments
The promise has not been fully delivered because broad safe, evidence-based access for veterans and others with treatment-resistant mental health conditions remains limited, and the leading MDMA-assisted PTSD application was not approved after FDA advisory concerns. However, there has been meaningful same-term progress: FDA issued psychedelic-drug clinical investigation guidance, held a public MDMA/PTSD advisory process, and federal review acceleration continued. Correa also appears directly connected through congressional organizing on psychedelic-assisted therapy research, which supports candidate credit for material advancement but not full fulfillment.