Government agencies are increasingly expressing support for allowing greater access to psychedelic drugs such as psilocybin and ibogaine and research into the therapeutic potential of those substances.
In April, President Donald Trump signed an executive order instructing the Food and Drug Administration and Drug Enforcement Administration to accelerate research, approval, and rescheduling for psychedelic pharmaceutical formulations demonstrating promise as medications for individuals with serious psychiatric diagnoses.
The EO also called on the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) to create a pathway for eligible patients to access some psychedelic pharmaceuticals through the Right to Try Act, which allows some patients with life-threatening illnesses to try investigational drugs not yet approved by the FDA.
In July the FDA released updated guidance for the development of psychedelic pharmaceuticals and entered into a partnership with the Department of Health and Human Services and Department of Veterans Affairs to advance Trump’s April EO by providing a “framework for collaboration and the exchange of information to accelerate action on treatments for substance use disorder and mental health conditions.”
A document shared with Health Care News by the veteran advocacy group Veterans Exploring Treatment Solutions, also known as VET Solutions, notes although the EO sends a strong political signal and “Dramatically accelerates FDA review timelines,” it “Does not create new law.”
As a result, the scientific investigation of potential psychedelic therapeutics remains difficult while the timeline for patient access is still unclear.
Implications of Schedule I Status
Most psychedelics are considered Schedule I drugs by the DEA, meaning they are more tightly regulated than other drugs and by definition lack any known medical use and have a high potential for abuse.
Although evidence presented in the scientific literature and by patient experiences has challenged the appropriateness of this definition for psychedelic drugs, the continued designation of many psychedelics as Schedule I drugs makes research more difficult and creates additional obstacles for both pharmaceutical companies trying to bring psychedelic therapies to market and patients who wish to pursue them as treatment options.
Research Hurdles
Michael Silver, a professor at the University of California-Berkeley’s Helen Wills Neuroscience Institute who studies the effects of psilocybin on visual processes, as well as its effects on older adults, says working with a Schedule I drug creates a “huge regulatory burden for researchers.”
Comparing his work with psilocybin to previous work he did on prescription medications for Alzheimer’s disease, Silver said, “It’s easily ten times more effort and money to do that kind of research with Schedule I substances.”
In part, Silver, who also serves as faculty director of the Berkeley Center for the Science of Psychedelics, said this is because of the need to comply with regulations over how the drug is “properly stored and recorded, and is not diverted.”
Vincent Joralemon, director of the Life Sciences Law and Policy Center at the UC-Berkeley School of Law, said, “When a drug is Schedule I, there are just huge amounts of hurdles.”
“I know a lot of researchers who really want to research this stuff, but they just go, ‘It’s just not worth it. It would be too difficult,’” Joralemon said.
Rescheduling Necessary
As for navigating the drug approval process, John Clifton, director of research and education at VET Solutions, says getting a drug through clinical trials and the FDA approval process can be difficult enough for any drug, and the situation for psychedelics is unique.
“New drugs don’t usually have to contend with the DEA,” Clifton said. “If a drug gets approved through the FDA, then they go through the kind of medical process of ‘Alright, we’ll move it into prescription.’ They don’t have to figure out rescheduling of that drug.”
Even if the FDA were to approve a psychedelic pharmaceutical to treat a condition such as post-traumatic stress disorder or treatment-resistant depression, doctors could still find themselves prohibited from prescribing it if the DEA does not reschedule the drug, says Clifton.
“My understanding is that even if the FDA approves a [psychedelic] drug, then the DEA has to independently go through their own process of review … and they decide ultimately if they’re going to take it off the Controlled Substances Act or if they’re going to change it from Schedule I to II, III, IV, etc.,” said Clifton.
“It’s not automatic,” said Joralemon. “Ideally, that’s something [that], with Trump’s executive order, will be expedited.”
State Action Needed
A bipartisan bill introduced in the U.S. House of Representatives on June 30, the “Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy Act,” or “IBOGAINE Act,” would expedite DEA review for rescheduling if a Schedule I drug were to complete Phase III clinical trials successfully.
Even if it were to pass, additional obstacles at the state level would remain. Logan Davidson, director of policy and advocacy at VET Solutions, says FDA approval and DEA rescheduling alone would not guarantee a psychedelic drug would be readily accessible in all 50 states.
States, said Davidson, need to be “thinking about licensure, provider training, all the things that are going to take [a psychedelic pharmaceutical] to not just being approved but to where you as a patient can go to your medical provider and say ‘Hey, I’ve got this diagnosis and I want to get this treatment,’ and they’ll actually know where to send you.”
Davidson says states would have to decide on rescheduling.
“Across the fifty states, there are a lot of different approaches to state rescheduling,” Davidson said. “Some of them, it’s automatic with the federal government. Some, there’s an agency review process. … Some require the state to pass an entirely new law.”
Off-Label Prescriptions
If a psychedelic pharmaceutical were approved by the FDA and subsequently rescheduled by the DEA, access and affordability might remain difficult for some patients as the drug, at least initially, would be approved only for a specific condition, though that status would “crack open a whole world of off-label use,” said Clifton.
Insurance coverage poses a problem for off-label uses, says Joralemon.
“The complicating factor there is that insurance often covers [only] FDA-approved indications, and it usually does not approve off-label uses,” said Joralemon. “The downside to that is if you have, for example, treatment resistant-depression, insurance might cover it and it will be way cheaper for you. If you have major depressive disorder, it might not.”
