The Food and Drug Administration (FDA) granted this Friday an expedited review of three experimental psychedelic drugs intended for the treatment of major depression and post-traumatic stress disorder.
It is the latest move by Donald Trump’s administration to signal a policy shift toward treatments that also produce a euphoric high in users, and comes a day after the Justice Department announced it would ease restrictions on state-authorized medical marijuana.
The Administration declined to reveal which pharmaceutical companies have received priority vouchers for what is typically a months-long FDA review. Two of the companies are expected to file applications for psilocybin to treat major depression or depression resistant to standard treatments. Another unnamed company has been researching a drug called methylone, similar to MDMA, for PTSD.
The push to increase research and access to alternative therapies for mental health problems, specifically psychedelics, has been led in part by war veterans.
“There’s a battle that’s still going on in his mind that we don’t fully understand biochemically,” said FDA Commissioner Marty Makary. “When you see something that looks promising for a community suffering from mental illness, despair and suicidal ideation, you can’t help but recognize it.”
On Monday, Makary told NBC News that with the priority voucher program, the agency could approve the first psychedelic drug by the end of summer.
The program was launched in June of last year. It aims to speed up the review process for drugs or products that are considered urgently needed, and can reduce the time it takes to obtain FDA approval from a year to just a few months.
Critics of the program say it was launched without consulting Congress and could ultimately undermine confidence in the FDA’s regulatory process by opening the door for companies to make financial contributions to the Administration in an attempt to obtain such a coupon.
The road to approval of any drug can be bumpy. In 2024, the FDA rejected MDMA, a psychedelic drug commonly known as ecstasy, for the treatment of post-traumatic stress disorder (PTSD), despite intense political pressure from veterans groups to have it approved. The agency informed pharmaceutical company Lykos Therapeutics that there was insufficient evidence that the therapy was safe and effective. An independent FDA advisory committee highlighted serious concerns regarding the research, including poor study design, allegations of sexual misconduct during one of the trials and the potential for health risks from taking the drug, including heart problems and abuse.
Research on psychedelics has been limited. The drugs are illegal in the United States and any real-world effects have been anecdotal and based on use in other countries.
Last weekend, President Donald Trump signed an executive order aimed at boosting U.S.-led research on psychedelics.
Experts studying these types of drugs welcomed rigorous scientific scrutiny.
Dr. Peg Nopoulos, chair of the department of psychiatry at the University of Iowa, said she was “happy to see they are paving the way” for this type of research. He has led studies comparing psilocybin to ketamine for the treatment of alcohol use disorder. Both substances can cause a psychedelic experience in users.
Psychedelics are “powerful drugs. I’ve seen them save lives,” Nopoulos said. “However, I am a scientist, and there is no way we can approve a drug without understanding who is going to benefit from it, who is not going to benefit from it, and what the risks are.”
“The science behind it has to be rock solid,” he added.
Friday’s move also allows researchers to study a form of the psychedelic ibogaine for the first time in the United States. Miami-based pharmaceutical company DemeRx NB will investigate a derivative of the drug, noribogaine hydrochloride, as a possible treatment for alcohol use disorder. Nearly 28 million Americans — 1 in 10 — suffer from 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 disturbing high associated with ibogaine.
