Psychedelics Policy Newsletter: DEA considers rescheduling psilocybin, FDA releases rejection decision, and more

Welcome to Reason Foundation’s newsletter on psychedelics policy. This edition covers:

• DEA petition to reschedule psilocybin
• Reason testimony on ibogaine in Mississippi
• FDA releases MDMA decision
• Interview for a new book on psychedelics

DEA petition requests psilocybin rescheduling

The Drug Enforcement Administration (DEA) has requested that the Department of Health and Human Services (HHS) review the scheduling of psilocybin under the Controlled Substances Act. This means that the federal government could choose to change psilocybin from Schedule I (where all use is banned) to a lower schedule (where use may be allowed under certain guidelines).

Schedules III through V are for approved pharmaceuticals subject to varying levels of controlled access. Companies or individuals that traffic in these substances can access basic financial services and are not subject to special penalties on their federal income taxes, even if state laws allowing the sale of these substances differ from federal law. A key takeaway of the potential change is that psilocybin service centers in state-regulated markets, such as Oregon, would be able to deduct business expenses on their federal income taxes under the “ordinary and necessary” standard that applies to most businesses.

This request from the DEA follows a protracted legal battle by proponents, including Sunil Aggarwal, a Washington State-based doctor, who sought to treat a patient with psilocybin under “Right to Try,” a federal law that permits the use of drugs not approved by the Food and Drug Administration (FDA) under certain conditions. There is no word yet from HHS regarding when or how it will respond to the DEA’s request. Legally, the U.S. attorney general has the authority to change the status of a drug, provided that DEA and HHS have jointly considered a number of factors outlined in statute.

Reason testimony in the state roundup

Reason Foundation’s Geoff Lawrence traveled to Mississippi to testify during a hearing related to ibogaine. Lawrence discussed the medical benefits of ibogaine as a potential treatment for opioid addiction. He also discussed recent states that have approved millions of dollars in funding for clinical trials involving ibogaine, such as those in Texas and Arizona.

These public grants could contribute enough funding to take ibogaine through the initial phase of the Food and Drug Administration’s (FDA) drug approval process.

Read this and more about state-level policies in the state round-up here.

FDA releases rejection decision

The FDA has released details of its decision to reject a New Drug Application for MDMA. Last August, the FDA made headlines for rejecting the application of Lykos, a pharmaceutical company that had long been the frontrunner for medicalizing psychedelics with a patented version of MDMA for the treatment of post-traumatic stress disorder. The Multidisciplinary Association of Psychedelic Sciences (MAPS) published a critique of the decision, arguing that the FDA “moved the goal posts” on the clinical trial design.

According to MAPS, the FDA was fully aware of many of the limitations when it greenlit the organization’s clinical trial design. For instance, the FDA was ultimately concerned that too many participants ”broke” blinding because they were able to guess whether they received the drug or a placebo. Genuine blinding is a gold standard of clinical trials, but a challenge with mental health-related drugs that have acute effects (like potent psychedelics).

The FDA is now requiring more research. MAPS leadership had created a for-profit company, Lykos, to conduct the trials. Currently, it is unknown if and how Lykos will address these challenges in further research.

Book interview

Reason Magazine Editor-at-Large Nick Gillespie interviewed Joe Dolce about his new book, Modern Psychedelics: The Handbook for Mindful Exploration. Dolce argues that psychedelics have moved from an obscure interest of the counterculture to a mainstream treatment.

“No matter what happens, people are going to use these substances,” says Dolce, when asked about possible legalization policies. Gillespie noted that better public policies would help users make more informed decisions.

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