WASHINGTON, D.C. – 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.
“As our nation faces mental health and substance use disorder crises, Congress has a role to play to ensure that our loved ones, including our veterans, have access to treatment options,” Rep. Dean said. “Our bipartisan legislation reduces barriers that will enable better research and compassionate use of two innovative and potentially lifesaving treatments — MDMA and psilocybin. We must always work to break stigma and help make recovery possible for more people.”
"Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses. It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies,” Rep. Mace said. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.
“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,” Sen. Booker said. “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.”
“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,” Dr. Paul said.
A letter of support from Reason for Hope can be found here.
A letter of support from the Veteran Mental Health Leadership Coalition can be found here.
Rep. Madeleine Dean is a mother, grandmother, attorney, professor, former four-term member of the Pennsylvania House of Representatives, and U.S. Representative for the Fourth District of Pennsylvania.
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