FILE PHOTO: Psilocybin or “magic mushrooms” are seen in an undated photo provided by the U.S. Drug Enforcement Administration in Washington, May 7, 2019.
DEA | Reuters
The US Food and Drug Administration on Friday announced a series of measures aimed at speeding the development of psychedelic treatments for serious mental illnesses.
This comes after President Donald Trump signed an executive order on Saturday directing federal health agencies to expand access to emerging therapies.
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, the FDA said.
“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 therapies with Breakthrough Therapy designation, where initial evidence shows significant improvement.”
As part of the announcement, the FDA said it would issue national priority vouchers to companies studying psilocybin for depression and methylone for post-traumatic stress disorder.
The agency also authorized 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 a compound like this has been cleared for study in the US and trial in humans.
“These drugs have the potential to address the country's mental health crisis,” FDA Commissioner Marty Makary said in the announcement. “It is essential that its development is based on sound science and rigorous clinical evidence.”
The FDA said allowing these studies to continue does not mean the drugs are approved or proven safe and effective. 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 the drugs that are prescribed and picked up at a pharmacy,” Makary told CNBC.
Makary went on to say that decisions on some of these therapies could be made as soon as this summer or fall.
Rapid turnaround time for drug approvals has been a priority for the Trump administration, which earlier this year abandoned the decades-old standard of requiring two clinical trials for standard drug reviews. The new policies have drawn some criticism, as industry experts have warned of potential problems with a faster schedule.
With Friday's psychedelic announcement, the Trump administration also said price remains an important consideration in accelerated trials.
“We've said very openly that affordability is an important part of a drug's effectiveness at the population level,” Makary said. “Reducing drug prices is a top priority of this administration, and it's something we think about in every decision, including how we prioritize vouchers.”
The announcement also comes after the Trump administration said it would ease restrictions on state-licensed medical cannabis operators.
