FDA fast-tracks psychedelic drug research following Trump order

The U.S. Food and Drug Administration on Friday announced a series of measures aimed at accelerating the development of psychedelic treatments for serious mental illnesses.

This comes after President Donald Trump signed an executive order Saturday directing federal health agencies to expand access to emerging treatments.

The FDA said the move marks a significant shift toward supporting psychedelic-based medications for conditions such as treatment-resistant depression, post-traumatic stress disorder and other substance use disorders.

“Under President Trump’s leadership, we are accelerating research, approval, and responsible access to promising mental health treatments,” Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services, said in the statement. “The FDA will prioritize treatments called Breakthrough Therapies where early evidence shows meaningful improvement.”

As part of the announcement, the FDA said it would issue national priority vouchers to companies working on psilocybin for depression and methylone for PTSD.

The agency also approved an early-stage clinical trial for noribogaine hydrochloride, a derivative of ibogaine, as a potential treatment for alcohol use disorder. This is the first time such a compound has been approved for study and human trial in the United States.

“These drugs have the potential to address the nation’s mental health crisis,” FDA Commissioner Marty Makary said in the announcement. “It is critical that their development is based on sound science and rigorous clinical evidence.”

Allowing these studies to continue does not mean the drugs are approved or proven to be safe and effective, the FDA said. Officials said the data will be closely monitored as the investigation progresses.

“If they are approved, they will be approved with certain conditions. These are not drugs that you can buy with a prescription and pick up at the pharmacy,” Makary told CNBC.

Decisions on some of these treatments could be made this summer or fall, Makary said.

Fast turnaround time for drug approvals has been a priority for the Trump administration. lowered the decades-old standard Mandatory two clinical trials for standard drug reviews earlier this year. New policies came with some criticismAs industry experts warn of potential problems with a faster schedule.

Along with Friday’s psychedelic announcement, the Trump administration also said pricing remains an important consideration in fast-moving trials.

“We have said very clearly that affordability is an important part of a drug’s effectiveness at the population level,” Makary said. “Lowering drug prices is one of this administration’s top priorities, and it’s something we consider in every decision, including how we prioritize coupons.”

The announcement also comes after the Trump administration said it would ease restrictions on state-licensed medical marijuana operators.