March 7, 2023

WASHINGTON, D.C. – Today, U.S. Senators Rand Paul (R-KY) and Cory Booker (D-NJ) introduced an updated version of the Breakthrough Therapies Act. This legislation will remove regulatory hurdles that inhibit research and compassionate use access to potentially lifesaving treatments that are heavily restricted by Schedule I of the Controlled Substances Act.

U.S. Representatives Nancy Mace (R-SC) and Madeleine Dean (D-PA) introduced companion legislation in the House of Representatives.

In recent years, two substances currently classified as Schedule I drugs—MDMA and psilocybin—have shown exceptional promise in treating an array of mental health conditions, including treatment-resistant suicidal depression, anxiety, PTSD, and substance use disorders. The initial research has been so promising that the FDA has designated MDMA- and psilocybin-assisted therapies as “breakthrough therapies,” meaning that they demonstrate substantial improvement over any currently available treatments.

However, due to the Schedule I status of MDMA and psilocybin, unnecessary red tape hinders critical research and access to treatment even for patients with terminal or life-threatening conditions. The Breakthrough Therapies Act would resolve these problems by expediting the transfer of substances that receive breakthrough therapy designation from Schedule I to Schedule II, which – with DEA oversight – will enable patient access and reduce the burden on further clinical investigation.

“As a physician, I’m proud to co-lead this legislation with Senator Booker to get the government out of the way and expand compassionate medical use for patients in need of care,” said Dr. Paul.

“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,” said Sen. Booker. “This bill will eliminate unreasonably burdensome rules and regulations that delay or prevent researchers from studying these breakthrough mental health treatments, and will provide access to these promising therapies for eligible patients who urgently need care.”

The text of the bill can be found HERE


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