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.
To build a hub of resources for bereaved families, to create and maintain public gardens to honor of those lost to substance use and other deaths of despair, and to explore viable solutions for those suffering from substance use and mental health issues.
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We aim to be a nurturing community of bereaved families to collaborate and support each other. We are redefining what joy, success, and normal look like and we welcome your input.