The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder. It’s the latest move by the Trump administration signaling a shift in policy toward treatments that also give users a high — coming a day after the Justice Department said it would ease restrictions on state-licensed medical marijuana.
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The administration declined to say which pharmaceutical companies have been issued priority vouchers for what’s usually a lengthy, months-long FDA review. Two of the companies are expected to submit applications for psilocybin to treat either major depression or depression that is resistant to standard treatments. Another unnamed company has been investigating a drug called methylone, which is similar to MDMA, for PTSD.
In a press release Friday, FDA commissioner Marty Makary said the medications “have the potential to address the nation’s mental health crisis, including conditions like treatment resistant depression, alcoholism and other serious mental health and substance abuse conditions.”
On Monday, Makary told NBC News that with the accelerated application process, the FDA could potentially approve the first psychedelic drug by the end of summer.
The FDA’s priority voucher program began in June 2025. It’s intended as an effort to speed up the review process for drugs or products deemed urgently needed — and can cut the time it takes for FDA approval from a year to just a few months.
Critics of the program say it was put in place without seeking input by Congress, and could ultimately undermine trust in the FDA’s regulatory process by opening the door for companies to make financial contributions to the administration in an attempt to secure such a voucher.
Research into psychedelics has been limited. The drugs are illegal in the U.S. and any real-world effects have been anecdotal and based on usage in other countries.
Last weekend, President Donald Trump signed an executive order meant to spur U.S.-led research into psychedelics.
Experts who study such drugs welcomed rigorous, scientific scrutiny.
Dr. Peg Nopoulos, chair of the University of Iowa’s psychiatry department, said she was “happy to see that the wheels are being greased” on such research. Nopoulos has led research comparing psilocybin to ketamine for alcohol use disorder. Both can give users a psychedelic experience.
Psychedelics are “powerful drugs. I’ve seen them save lives,” Nopoulos said. “However, I’m a scientist, and there’s no way we can approve a drug without understanding who’s going to benefit from it, who’s not going to benefit from it and what the risks are.”
“The science behind it has to be rock solid,” she said.
Friday’s action also permits researchers to study a form of the psychedelic ibogaine for the first time within the U.S. Miami-based drug company DemeRx NB will research a derivative of the drug, noribogaine hydrochloride, as a potential treatment for alcohol use disorder. Nearly 28 million — 1 in 10 — Americans have alcohol use disorder, according to the National Institute on Alcohol Abuse and Alcoholism.
Noribogaine reportedly does not induce the intense, hours-long and sometimes emotionally upsetting high associated with ibogaine.