Bipartisan and bicameral congressional lawmakers have filed an updated version of a bill to streamline the federal rescheduling of “breakthrough therapies” like psilocybin and MDMA in order to promote research and drug development.
Sens. Cory Booker (D-NJ) and Rand Paul (R-KY)—along with Reps. Madeleine Dean (D-PA) and Nancy Mace (R-SC)—announced on Thursday the introduction of the “Breakthrough Therapies Act.”
The legislation proposes to amend the federal Controlled Substances Act (CSA), in part 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.
When a drug meets either of those criteria, they would be placed in Schedule II, which is reserved for drugs with “currently accepted medical use with severe restrictions.”
“According to recent studies, certain Schedule I substances such as MDMA and psilocybin could offer major advancements in the treatment of depression, severe post-traumatic stress disorder, and addiction,” Booker said in a press release. “This bill will eliminate unreasonably burdensome rules and regulations that delay or
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