Psychedelics are on the FDA’s mind
September 11, 2026 - Politico
The FDA is focusing more attention than usual on psychedelics this month as the prospect of the first agency approval for the drug class gets closer.
The agency will hold a public hearing on the potential future therapeutic use of psychedelic drugs on Monday. Regulators seek comment on several issues pertaining to their use in supervised settings, including patient safety, access considerations, data-collection best practices and provider training and credentialing.
President Donald Trump signed an executive order in April directing federal agencies to boost research efforts into psychedelic medicine, and the Food and Drug Administration issued priority review vouchers to three companies developing psychedelics to treat mental health conditions. One of them, Compass Pathways, is expected to complete its application for a synthetic psilocybin therapy for treatment-resistant depression by the fourth quarter.
The ‘new framework’: FDA officials — led by newly minted Center for Drug Evaluation and Research Director Mike Davis — published an opinion piece Wednesday in The New England Journal of Medicine outlining how they expect to approach psychedelic drug applications, building on July guidance on clinical studies of the substances.
The commentary underscores that the agency could consider alternative controls, like dosage differences, to traditional placebos that might risk unblinding trial participants, or revealing to them whether they received experimental treatment.
The officials said the FDA is also “receptive” to initially approving applications based on relatively short efficacy studies — suggesting 12 weeks as a viable period — while requiring further study in the postmarketing period, such as safety studies on the ideal number of doses and time between them. The agency may also mandate a Risk Evaluation and Mitigation Strategy — its drug safety program known as REMS — for psychedelics to stipulate specific conditions to assure safe use.
Speaking of which: Federal officials are also eyeing psychedelics as they consider ways to reduce the clinical use of opioids, POLITICO’s Amanda Friedman reports.
The FDA convened a meeting Wednesday with the Reagan-Udall Foundation — a nonprofit that Congress established to support agency initiatives — to discuss potential regulatory pathways to help reduce patients’ reliance on opioid medications like methadone and buprenorphine to treat drug addiction and oxycodone to manage pain.
The discussion will inform a congressionally required report, due in December, evaluating the public health effects of the addictive drugs.
Think of us: Ahead of next week’s meeting, the American Academy of Pain Medicine has already submitted comments urging federal officials to consider the next wave of indications — especially chronic pain management — likely to come for FDA-approved psychedelics, given those patients’ unique needs compared with psychiatric uses.
“The delivery infrastructure being contemplated now, which includes curricula, credentialing pathways, screening protocols, monitoring standards, common data elements, and payment models, will nonetheless become the default scaffolding for every indication that follows,” the group wrote. “If those differences are not accounted for at the design stage, the resulting framework will require expensive retrofitting or will function as a barrier to indications FDA may later approve.”
* Also read related article:
There Will Be ‘Enormous Demand’ For Psychedelic Treatments, RFK Says, Praising Trump’s Action On The Issue - Marijuana-Moment, Sept 11, 2026
|
Threaded
Previous
Index
Next
Unfolding Nature: Being in the Implicate Order 
Mono Tub Substrate
veggie
Edit 
Reply 
ClusterHead
TinTree
Seuss
1 2 all )
bowling-name
Anno