Bipartisan Bill Would Reschedule ‘Breakthrough Therapy’ Psychedelics & Improve Research

Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced a bill last week for the federal lame-duck legislative session that would boost research opportunities for psychedelic substances with a “breakthrough therapy” designation from the FDA, Marijuana Moment reports. The bipartisan Breakthrough Therapies Act would update the Controlled Substances Act to reschedule potential new drug candidates like psilocybin and MDMA from Schedule I to Schedule II as they are flagged by the FDA, in turn improving new drug research and development opportunities.

Sen. Paul said in a press release he was “proud” to propose a bipartisan solution to “make it easier for researchers to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions.”

The proposal shadows a trend of psychedelics reform including statewide legalization votes in Oregon and Colorado and significant decriminalization reforms in many U.S. cities such as Denver, Oakland, Seattle, and Washington D.C.

“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. 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.” — Sen. Cory Booker, in a press release

The bill’s introduction also coincided last week with the launch of the bipartisan Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus — formed by Reps. Lou Correa (D-CA) and Jack Bergman (R-MI) — which seeks not to legalize or regulate psychedelic substances but to educate lawmakers and the public about their therapeutic potential.

Additionally, Congress last week passed the Medical Marijuana and Cannabidiol Research Expansion Act, the country’s first-ever standalone cannabis reforms bill, which will expand research opportunities into medical cannabis and protect doctors while discussing the risks and benefits of cannabis with their patients.