File photo: Psilocybin or “magic mushrooms” are shown in an undated photo provided by the U.S. Drug Enforcement Administration in Washington, May 7, 2019.
Drug Enforcement Administration | Reuters
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 on Saturday directing federal health agencies to expand access to new treatments.
The move marks a major shift in support for psychedelic-based medicines 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,” Secretary of Health and Human Services Robert F. Kennedy Jr. said in a statement. “FDA will prioritize treatments with Breakthrough Therapy designation that show meaningful improvement in early evidence.”
As part of the announcement, the FDA announced it would issue national priority vouchers to companies researching psilocybin for depression and methylone for PTSD.
The agency also approved early-stage clinical trials of 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 research and human trials in the United States.
“These treatments have the potential to address the nation’s mental health crisis,” FDA Commissioner Marty McCulley said in a statement. “It is important that its development is based on sound science and rigorous clinical evidence.”
The FDA said allowing these studies to proceed does not mean the drug has been approved or proven to be safe and effective. Officials said the data will be closely monitored as the study progresses.
“If it’s approved, it will be approved with certain conditions. These are not drugs that you get with a prescription and pick up at a pharmacy,” McCurry told CNBC.
McCurry also said decisions on some of these treatments could be made as early as this summer or fall.
Speeding drug approvals has been a priority for the Trump administration, which earlier this year eliminated the decades-old requirement that standard drug reviews require two clinical trials. There has also been some criticism of the new policy, with industry experts warning of potential problems with the faster schedule.
With Friday’s psychedelic announcement, the Trump administration also said pricing remains an important consideration in rapid clinical trials.
“We’ve said very publicly that a key part of a drug’s effectiveness at the population level is affordability,” McCurry said. “Reducing drug prices is one of this administration’s top priorities, and we take it into account in every decision we make, including the prioritization of vouchers.”
The announcement also follows the Trump administration’s announcement that it would ease regulations for state-licensed medical marijuana businesses.
