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A new bill, the Breakthrough Therapies Act, would encourage the reclassification of MDMA and psilocybin from schedule I to schedule II drugs.
Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced a new bill, the Breakthrough Therapies Act, that would allow the Drug Enforcement Administration to make findings to reclassify MDMA and psilocybin as schedule II drugs. MDMA and psilocybin are currently schedule I substances and have “no currently accepted medical use and a high potential for abuse,” according to the Controlled Substances Act.
“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,” Booker said. “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.”1
The passage of this legislation could help facilitate a phased roll-out of MDMA and psilocybin via FDA-approved Expanded Access pilot programs. Additionally, it would lessen federal regulations that impede research and development of drugs listed in schedule I.
“I’m proud to co-lead this legislation with Sen. Booker that would streamline the registration process for breakthrough therapies currently restricted by outdated drug classifications,” said Paul. “This bill will make it easier for researchers to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions.”1
Martin R. Steele, a retired Lieutenant General in the United States Marine Corps, Chief Executive Officer of Reason for Hope, and head of the recently formed Veteran Mental Health Leadership Coalition is strongly in favor of the bill’s passage: "We urge Congress to swiftly pass the Breakthrough Therapies Act, which responsibly reduces the barriers to research and limited access of potentially life-saving treatments like MDMA- and psilocybin-assisted therapy,” said Steele. “Veterans should not be forced (nor should anyone else) to leave the country—at great expense—to access breakthrough therapies that can be safely provided and further studied in real-world settings here at home."1
1. Booker, Paul introduce bipartisan legislation to promote research and access to potential life saving drugs. Cory Booker. News release. November 17, 2022. Accessed November 22, 2022. https://www.booker.senate.gov/news/press/booker-paul-introduce-bipartisan-legislation-to-promote-research-and-access-to-potential-life-saving-drugs