The FDA is accelerating research into psychedelic drugs under Trump’s order
FILE PHOTO: Psilocybin, or “magic mushrooms,” are seen in an undated photo released by the U.S. Drug Enforcement Administration in Washington on May 7, 2019.
DEA | Reuters
The U.S. Food and Drug Administration announced Friday a series of actions 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 officials to expand access to new therapies.
The move represents a significant shift toward supporting psychedelic 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,” U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in the release. “The FDA will prioritize breakthrough therapy designations for which initial evidence shows meaningful improvement.”
As part of the announcement, the FDA said it would issue national priority vouchers to companies studying 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 disorders. This is the first time a compound of this type has been approved for U.S. studies and human testing.
“These medications have the potential to address the nation’s mental health crisis,” FDA Commissioner Marty Makary said in the announcement. “It is crucial that their development is based on sound science and rigorous clinical evidence.”
The FDA said that approval of these trials does not mean that the drugs are approved or have been proven to be safe and effective. Officials said the data will be closely monitored as the research progresses.
“If they are approved, they will be approved under certain conditions. These are not the drugs that you get a prescription for and pick up at the pharmacy,” Makary told CNBC.
Makary continued that decisions on some of these therapies could come as early as the summer or fall.
Fast 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 guidelines drew some criticism as industry experts warned of potential problems with a faster timeline.
With Friday’s psychedelic announcement, the Trump administration also said pricing remains an important consideration in accelerated trials.
“We have been very open about the fact that affordability is an important factor in the effectiveness of a drug at the population level,” Makary said. “Reducing drug prices is one of this government’s top priorities and we think about it in every decision, including when prioritizing vouchers.”
The announcement also follows the Trump administration’s announcement of easing restrictions on federally licensed medical cannabis operators.
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