Reps. Dean and Mace Join Sens. Booker and Paul to Introduce Bipartisan Legislation to Promote Research and Access to Potential Life Saving Drugs

Today, Congresswoman Madeleine Dean (PA-04) and Congresswoman Nancy Mace (R-SC) introduce the Breakthrough Therapies Act; U.S. Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) introduced a companion bill in the Senate. This bipartisan 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.

In recent years, two substances currently classified as Schedule I drugs — MDMA and psilocybin — have shown exceptional promise in treating 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.

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