Congress takes another look at reclassifying psilocybin and MDMA

Months after Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced a bill that would expand access to Schedule I drugs for terminally ill patients, the lawmakers are taking another stab.

Booker and Paul on Thursday introduced a new bill called the Breakthrough Therapies Act, which would allow the Drug Enforcement Administration to make the necessary findings to reclassify breakthrough therapies such as MDMA or psilocybin as Schedule II drugs.

The Controlled Substances Act was enacted in 1970, and separates substances into five schedules, with Schedule I being the most serious. MDMA and psilocybin are currently Schedule I substances, meaning they have “no currently accepted medical use and a high potential for abuse” according to the CSA’s language. Schedule II drugs are still characterized as having a high risk of abuse, though they include medicines such as OxyContin and Dilaudid.

Reclassifying certain therapies that contain Schedule I substances would “help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs,” the senators said, and “remove burdensome federal regulations that impede research and development.”

The new bill differs from their previously introduced Right to Try Clarification Act, which would skirt around the FDA’s expanded access program and the DEA’s regulations around controlled substances, and allow patients to potentially access Schedule I drugs more easily.

“Recent studies suggest that some Schedule I substances such as MDMA and psilocybin could represent an enormous advancement for the treatment of severe post-traumatic stress disorder, depression and addiction,” Booker said in a news release on Thursday. “Unfortunately, regulatory red tape and a series of bureaucratic hurdles involved in studying Schedule I substances impedes critical research on these and other promising Schedule I compounds.”

Psilocybin, an active substance in “magic mushrooms,” is currently under development by a variety of companies for conditions such as PTSD and treatment-resistant depression. Similarly, MDMA has been studied in PTSD and anxiety in terminally ill patients.

Booker and Paul aren’t the first to suggest that certain therapies containing Schedule I substances should be reclassified. Just last month, Seattle doctor Sunil Aggarwal took his fight to change psilocybin’s CSA status to federal court. While Aggarwal had asked the DEA in February to reclassify psilocybin as a Schedule II substance, the agency responded that the FDA “has not articulated any accepted medical use” for the drug. On Oct. 20, he petitioned the Ninth Circuit Court of Appeals to review the DEA’s decision.

Robert Barrow, whose company MindMed is developing a range of therapies based on psychedelics such as psilocybin, LSD and MDMA, told Endpoints News on Friday that “seeing a step in the right direction in terms of enabling more streamlined research is really exciting.”

“One thing I would want to think about more fully and want to digest fully is the exact implication that it does put a high degree of focus on the designation of a product as a breakthrough therapy,” he added. “We see opportunities beyond just breakthrough therapy-designated products that could benefit from streamlined regulatory function here in the US.”

Read More