In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients taking these substances experience significant benefits for various neuropsychiatric conditions.
FDA Commissioner Marty Makary signaled his support for exploring the use of psychedelics to treat neuropsychiatric conditions, noting in an interview last Friday on NewsNation that the FDA will “take an expeditious and rapid review” of clinical data for psychedelic therapies in trials.
“I don’t think the medical establishment is listening to doctors” on the use of psychedelics, Makary said. “I don’t think we’re listening to patients.” He referred to patients and doctors who used what he called “plant-based therapies” and who reported feeling “curative” effects.
“What have we had to treat traumatic brain injury and PTSD [post-traumatic stress disorder] that has really had great results?” Makary asked. He cautioned, however, “I’m not saying they’re effective, I’m not saying the evidence is strong. I’m saying we have to listen to doctors who have these experiences.”
Patients who have taken psychedelics, according to Makary, had medical conditions like PTSD, severe refractory depression and traumatic brain injury. Psychedelics such as MDMA, psilocybin and ibogaine “significantly helped” their conditions, he said, without adding specifics.
Makary during the interview also pointed to ongoing trials that are set to read out “soon,” data from which he said the FDA will review rapidly.
In a Monday note to investors, Jefferies analysts took Makary’s statements as an endorsement of psychedelics, saying that this “suggests developing psychedelics and incorporating them into the CNS/neuro treatment paradigm could be a priority for the new FDA admin.”
Makary’s boss, Health and Human Services Secretary Robert F. Kennedy Jr., has also publicly supported psychedelics, previously accusing the FDA of “suppressing” these therapies, alongside other modalities such as stem cell treatments.
In August 2024—despite months of lobbying from various stakeholders—the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for PTSD. The rejection was in line with the outcomes of an advisory committee meeting, where external experts overwhelmingly refused to endorse the approval of Lykos’ proposed therapy.
Among the issues the advisors named were a problematic trial design, which they said was functionally unblinded because patients could easily determine if they were taking the psychedelic treatment or placebo. Some panelists also pointed to the “potential for some misconduct and manipulating the trial results.”
