Federal Bipartisan Effort Seeks to Reschedule Psychedelic Breakthrough Therapies

Federal lawmakers – from both sides of the aisle and in both Congressional bodies – are pushing for a means of streamlining so-called “breakthrough therapies” that involve psychedelic drugs like MDMA and psilocybin for the purpose of promoting drug research and development.

As longtime Los Angeles cannabis business attorneys, we help break down what legislators are after.

The new bill, introduced by Democrats and Republicans in both the House and Senate, is titled the, “Breakthrough Therapies Act.” It seeks to revise the U.S. Controlled Substances Act by establishing a procedure through which certain Schedule I narcotics can be considered “therapies” by the U.S. food & Drug Administration. Either that, or they could qualify for a waiver via the U.S. food, Drug, and Cosmetic Act (FDCA). This waiver would allow the drugs to be transferred under a lower-schedule classification to research facilities and pharmaceutical laboratories.

The bill says that drugs that meet certain criteria making them eligible for legitimate research could be rescheduled as Schedule II medications – which are heavily restricted, but accepted for certain medical uses.

The bill notes that substances like psilocybin (what’s found in so-called “magic mushrooms”) and MDMA (also known by the street name “ecstasy”) have already been identified as having potentially significant value in the treatment of conditions like addiction, depression, and post-traumatic stress disorder (PTSD). If Congress passes the bill, it would do away with rules and regulations that are unreasonably overbearing and either delay or outright prevent research that could be potentially very valuable for those struggling with serious and potentially fatal mental health conditions. Sen. Corey Booker (D-NJ) identified the patients who could benefit from this research as “urgently needing care.”

Across the aisle, Republican Senator Rand Paul (R-KY) said he was “proud to co-lead this legislation,” which he hopes will compel the government to take a backseat and allow doctors, scientists, and researchers to do the work necessary to determine whether these substances can prove a greater benefit to those grappling with mental health and addiction issues.

An older version of the same bill left out provisions that would have simplified the registration process and paperwork researchers needed to complete to request a reschedule of certain Schedule I narcotics.

As Los Angeles marijuana and CBD lawyers, we know that scientists and doctors have long lamented the burdensome process that accompanies research of drugs restricted by the U.S. Drug Enforcement Administration under the CSA – particularly Schedule I drugs, which marijuana still is. A bill addressing this issue with respect to marijuana – the “Medical Marijuana and Cannabidiol Research Expansion Act”  – was signed by President Joe Biden last year.

The new measure contains a provision that indicates any drug that is rescheduled from a Schedule I to a Schedule II for a breakthrough therapy or via a waiver could still be reverted back to a the high-level Schedule I if it’s established that there isn’t any accepted medical use absent the strictest of regulations. The process for doing so would require a recommendation from the leadership of the U.S. Department of Health & Human Services to the U.S. Attorney General’s Office. From there, the AG’s office would have three months to issue a final ruling regarding the drug’s scheduling.

A separate bill introduced last year called the “Right to Try” law would have given very ill patients the opportunity to take Schedule I narcotics (including psychedelics) under the recommendation of a physician. That measure, however, did not gain enough support to pass.

The Los Angeles CANNABIS LAW Group represents growers, dispensaries, ancillary companies, patients, doctors and those facing marijuana charges. Call us at 714-937-2050.

Additional Resources:

Cory Booker And Rand Paul File Revised Bill To Reschedule Psychedelic Breakthrough Therapies, March 7, 2023, By Kyle Jaeger, Marijuana Moment

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