Politics
States Should Start Planning Now For FDA Approval Of Psychedelics, Federal Report Says
A federal health agency has published a new report on recent advances in psychedelic medicine, along with recommendations for state policymakers on how to prepare for formal approval of drugs like psilocybin and MDMA. It also notes how the Schedule I status of many psychedelics has hampered scientific studies on their effects for decades.
“Psychedelic-assisted therapy is moving from research settings toward clinical practice faster than most observers anticipated even 5 years ago,” the report published on Wednesday by the Substance Abuse and Mental Health Services Administration (SAMHSA) says.
The document says that substances such as psilocybin, LSD and MDMA “show potential in clinical studies for treating depression, post-traumatic stress disorder, anxiety, and substance use disorders,” though it cautions that the evidence base “remains uneven and important methodological limitations persist.”
The SAMHSA report notes that President Donald Trump issued an executive order aimed at expanding and expediting research on the potential therapeutic benefits of psychedelics in April with an eye toward federal approval of psychedelic medications by the Food and Drug Administration (FDA).
State officials should “consider planning now for the fiscal, legal, and operational implications of potential FDA-approved psychedelic therapies, including any Medicaid coverage obligations,” it says.
They should also work toward “developing oversight frameworks, including credentialing standards, safety protocols, informed consent processes, and complaint mechanisms proactively, before psychedelic therapies are formally made available for state system service recipients,” the SAMHSA report recommends.
“States should engage with the federal regulatory process and coordinate across agencies so that relevant decision-makers in states are informed and prepared when psychedelic policy proposals arise.”
One methodological issue with most psychedelic research to date, the paper notes, is that clinical trials have largely excluded people with serious mental illness, low incomes and complex trauma histories—”precisely the populations that state mental health systems primarily serve.”
The SAMHSA paper provides an overview of the traditional and cultural use of psychedelics, as well as their legal status in the U.S., noting that their placement in Schedule I of the Controlled Substances Act (CSA) meant that “clinical research into psychedelics was substantially limited” for decades.
“This classification was viewed by many as a response to cultural panic surrounding recreational drug use in the 1960s rather than a science-based assessment,” it says.
Research has picked up in recent years, however, and FDA has granted “breakthrough therapy” status to several psychedelics, including psilocybin, MDMA and a 5-MeO-DMT formulation.
If any psychedelics are approved by FDA, key questions will arise about coverage through Medicaid and other programs—both for the drug itself as well as therapeutic sessions that can last for several hours.
“State Medicaid agencies could theoretically cover the drug but not the associated services. Such an arrangement would create a dilemma because the evidence for benefit appears inseparable from the therapeutic framework,” the report says. “Prescribing psilocybin or other psychedelics for unsupervised home use is not supported by the current evidence.”
But “if states are required to cover both the medication and therapeutic services, the budgetary implications are substantial,” the SAMHSA analysis notes.
In any case, the federal overview says that regardless of whether states approve or cover any psychedelic medicines or services, “access and use are already happening.”
“The question is not whether individuals in a particular state will use psychedelics, but whether they will do so in regulated, safe contexts or in underground networks,” it says. This has implications for what information to gather, what public health communications to develop, and what policies to put in place proactively.”
The report also says that an ongoing “fundamental legal tension is that federal and state laws may not align.”
“A state that permits psychedelic-assisted therapy outside of FDA-approval or authorized right-to-try expanded access creates a situation in which the state is facilitating conduct that remains federally criminal. This is not unprecedented (medical cannabis states face similar tensions), but it represents a real legal risk. State attorney general offices may be able to provide guidance on whether prescribers can legally administer Schedule I compounds under state law even when federal law prohibits them.”
Whatever happens at the federal level, psychedelics are unlikely to recede from public attention,” it says. “The science will continue to accumulate, and state agencies will face questions from service recipients, their families, providers, legislators, and others.”
“State mental health directors do not need to become advocates for psychedelic-assisted therapy, but they must be informed. The evidence base, the regulatory momentum, and the budget implications are all substantive enough to warrant serious attention now. The most prudent course is to stay informed, engage with the evidence critically, prepare for the possibility that FDA-approved psychedelic therapies may arrive soon, and think carefully about how these therapies might fit into the broader mission of serving people with mental health conditions and substance use disorders, including individuals with serious mental illness. These decisions are likely to come whether or not states are ready for them, and it will be easier to develop informed positions in advance than to react under pressure.”
Last month, the Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA) announced a partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.
Separately, FDA issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September.
Previously, FDA and HHS in April announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
In May, a bipartisan coalition of 32 members of Congress sent a letter urging FDA to expedite ongoing reviews of psychedelic therapies.
Lawmakers recently filed a new bill that would require the Department of Defense (DOD) to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military.
A separate recently introduced bipartisan measure is intended to codify Trump’s psychedelics executive order into law.
An amendment adopted as part of the National Defense Authorization Act would extend a psychedelics research effort at DOD for an additional six years.
