Psychedelics Move Forward In Congress: Sens. Booker And Paul File 'Breakthrough Therapies Act'

Thursday was another important day for psychedelics on Capitol Hill Senators Cory Booker (D-NJ) and Rand Paul (R-KY) jointly filed a bill requesting the DEA move psychedelic “breakthrough therapies” like psilocybin and MDMA from Schedule I to Schedule II, reported  Marijuana Moment. 

This happened shortly after Congress announced the creation of a Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus. The two measures are closely aligned, as the Senate bill demands removing research barriers for controlled substances, which includes psychedelics, while the caucus was created to promote the advancement of new treatments derived from these substances.

Booker and Paul's legislation proposes to amend the Controlled Substances Act (CSA) in such a way that current and future drugs designated as “breakthrough therapies” by the FDA, or qualify for a waiver under the Food, Drug and Cosmetic Act and be moved to Schedule II. 

As such, studies with filed registrations on Schedule I drugs would be made available sometime after notifying the Attorney General, while unregistered research would first petition the DOJ for accreditation which, if granted, is to be received within short notice. 

And, furthermore, studies on Schedule I substances led by different researchers within the same organization or taking place over several locations would only need to file a single registration. 

The new classification would still tightly restrict the use of these drugs to the medical field, yet would facilitate research and development.

Booker, who has previously called on the need for “safe and effective” psychedelic therapies, stated: “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.” 

Booker added that the new legislation would reduce these “unreasonably burdensome rules and regulations” delaying or preventing both researchers from studying and patients from accessing these potential therapeutics.

Paul has said he believes it would “streamline” the registration process for breakthrough therapies that are currently restricted by “outdated” drug classifications and thereby potentially offer treatment for “patients battling serious and life-threatening conditions.”

Photo courtesy of Irina Anosova and ANDREI ASKIRKA on Shutterstock.