By Kyle Jaeger
Bipartisan congressional lawmakers are applauding the Food and Drug Administration (FDA) for releasing first-ever draft guidance on psychedelics research—a development that they had requested through a new bill just days before the agency took the step.
Reps. Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) filed the legislation this month. And while FDA didn’t say that its decision to release the guidance was directly responsive to the measure, it’s precisely the action that the first part of the bill addressed.
“I’m glad the FDA is taking this first step of issuing guidance for psychedelic clinical trials—and listening to my bipartisan legislation with Reps. Miller-Meeks and Khanna,” Crenshaw said in a press release on Thursday. “It’s critical we get this right for the researchers doing this important scientific work.”
“We need this guidance to expand clinical trial access so that we can push towards life-saving psychedelic therapies for our veterans, servicemembers, and people living with PTSD, traumatic brain injury, and substance abuse disorder,” the congressman, a military veteran who has taken a leadership role on advancing psychedelics research, said.
FDA’s draft guidance provides scientists with a framework to carry out research that could lead to the development of psychedelic medicines.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.
“Many Veterans find guided use of psychedelics with assisted therapy as a way to successfully treat the excruciating, post-traumatic pain they face, with better outcomes and less medication side effects in pilot studies,” Miller-Meeks said. “As a physician, I know the importance of medical research and I am encouraged by the FDA’s support and guidance regarding psychedelic clinical trials. This important step gives our Veterans another option and hope when they feel they’ve run out of methods to cope.”
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 substances such as psilocybin and MDMA—both of which have already been designated by FDA as “breakthrough therapies.”
The agency’s draft guidance “describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application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.
Khanna, for his part, said that the agency’s guidance “is a critical step to help protect the well-being of veterans and those living with PTSD.”
“I’m proud to cosponsor this bill to expand the body of research on psychedelic therapies in the hopes of improving the health of many Americans,” he said.
The lawmakers’ bipartisan bill 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.
“There are open questions related to psychedelic-assisted therapy that need answers,” Veterans Exploring Treatment Solutions (VETS) said. “Unfortunately researching these compounds can be difficult due to administrative requirements related to scheduling status. We welcome efforts that reduce barriers to research and help pave the way for access to these lifesaving therapies.”
On the same day that the legislation was introduced last week, Crenshaw discussed it at a House Energy & Commerce Committee hearing, where he talked about psychedelics as one possible “solution” to the country’s substance misuse issues.
The congressman said that he was working on “getting clinical trial guidance for psychedelic therapies from the FDA,” adding that “this therapy will be earth-shattering. It already has been already changed dozens of lives.”
“We’re not talking about 1960s LSD trips. This therapy is supervised by a medical practitioner [and] often occurs with repeat treatments in a controlled setting,” he said. “And when it comes to the efficacy of this therapy, the proof is in the data, in the testimonies—but we need the FDA to issue clinical trial guidance for psychedelic assisted therapy so that the the industry can actually invest in this.”
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 earlier this 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.”
This 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.
At a Senate committee hearing in May, NIDA Director Nora Volkow told members that there’s emerging evidence that psychedelics carry “significant potential” as therapeutic treatments for certain mental health conditions, and it’s a topic of “great interest” for researchers.
Meanwhile, congressional lawmakers have also pushed for psychedelics reform.
For example, a powerful U.S. Senate panel has called on the U.S. Department of Veterans Affairs (VA) to explore the therapeutic potential of psychedelics.
On the House side, a congressional committee recently approved a large-scale defense bill that includes GOP-led provisions to create a medical marijuana “pilot program” and require a study into the therapeutic potential of psychedelics for active duty military members under the U.S. Department of Defense (DOD).
About three in five American voters say psychedelics should be legalized for regulated, therapeutic use—and nearly half believe possession should be decriminalized for personal use for any reason—according to a national poll released this month.
In a somewhat surprising twist, President Joe Biden’s younger brother disclosed this week that the president is “very open-minded” about the use of psychedelic medicines to treat addiction.
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