Cory Booker And Rand Paul File Bill To Reschedule Psychedelic Breakthrough Therapies And Remove Research Barriers
By Kyle Jaeger
November 17, 2022
Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill on Thursday that would require the Drug Enforcement Administration (DEA) to transfer breakthrough therapies like psilocybin and MDMA from Schedule I to II, while also removing research barriers for strictly controlled substances.
The “Breakthrough Therapies Act” was filed on the same day that bipartisan House lawmakers announced the formation of a congressional psychedelics caucus that’s meant to promote the development of novel treatments derived from currently controlled entheogenic substances.
The new Senate legislation proposes to make a series of amendments to the federal Controlled Substances Act (CSA), including by creating a procedure through which current Schedule I drugs that are deemed breakthrough therapies by the Food and Drug Administration (FDA) or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA) could be transferred to a lower schedule that would make them easier to study and promote drug development.
As soon as any drug receives a breakthrough therapy designation or qualifies for the FDCA waiver, that would trigger the administrative process for DEA to place it in Schedule II, which is reserved for drugs with “currently accepted medical use with severe restrictions.”
The other key components of the bill are largely borrowed from provisions of previous standalone legislation that are meant to simplify and expedite research into Schedule I drugs, which would cover certain psychedelics, as well as marijuana and other controlled substances.
...
Reply With Quote
Connect With Us