The bipartisan co-chairs of a congressional psychedelics caucus are touting the Food and Drug Administration’s (FDA) new draft guidance on researching substances like psilocybin and MDMA.
Reps. Lou Correa (D-CA) and Jack Bergman (R-MI), who founded the Psychedelics Advancing Therapies (PATH) Caucus last year, applauded the agency in a joint statement on Wednesday, commending FDA for “their considerable work in releasing the non-binding guidance for comment regarding the clinical study and development of psychedelic therapies for those suffering from mental and behavioral health conditions.”
They noted that FDA has already designated psilocybin and MDMA as “breakthrough therapies” for the treatment of severe depression and post-traumatic stress disorder (PTSD), respectively.
“As our country continues to suffer tragic rates of suicide and opioid overdose deaths, which disproportionately impact our Nation’s military Veterans, it is critical that policymakers such as those in our caucus pursue additional pragmatic measures—alongside the relevant agencies—to ensure that those who would benefit most from these potentially lifesaving therapies can get access as soon as possible,” the congressmen said.
The release of the draft guidance came just days after another set of bipartisan lawmakers filed a bill that specifically asked the agency to take that step.
Reps. Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) also reacted to the FDA move last week, crediting it for making progress in a way that was responsive to their legislation.
FDA’s draft guidance provides scientists with a framework to carry out research that could lead to the development of psychedelic medicines. A 60-day public comment period is open for interested parties to submit feedback on how final guidance should be shaped.
Interest in psychedelics has grown exponentially over recent years as cities and states across the country have moved to promote research, remove criminal penalties and regulate access to entheogenic substances.
The agency’s draft guidance “describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements,” FDA said.
The related bipartisan bill filed last week called on the secretary of the U.S. Department of Health and Human Services (HHS), acting through the FDA commissioner, to “issue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration.”
If enacted, it would have required FDA to produce that draft guidance within 180 days. But the agency was evidently prepared to release it much sooner. The bill would also mandate FDA to finalize its guidance 180 days after the draft document’s publication, so lawmakers may still be interested in advancing the measure with that provision.
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The FDA’s Federal Register filing notes that a public docket has been made available for people to submit comments on the draft guidance.
The move is timely, as lawmakers and health officials have shown serious interest in quickly expanding research into psychedelics as studies have revealed their potential in the treatment of conditions such as severe depression, post-traumatic stress disorder and addiction.
Marijuana Moment asked HHS Secretary Xavier Becerra last month about the department’s current thinking around psychedelics policy, and he said he needed to “defer” to the expertise of the National Institute on Drug Abuse (NIDA), which also falls under his agency, “because I want to make sure that I touch base with what they’ve been doing on that.”
Last month, NIDA called for research into the impact of evolving laws around psychedelics, including the effects of allowing regulated access to substances like psilocybin.
NIDA separately announced in May that it is soliciting proposals for a series of research initiatives meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.