Bipartisan Bill Would Promote Medical Research

Capitol Comments

Senator Cory Booker

WASHINGTON, D.C. – U.S. Senator Cory Booker (D-N.J.) and U.S. Senator Rand Paul (R-KY) 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.

“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 Senator 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.”

“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.

“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 Martin R. Steele, a retired Lieutenant General in the United States Marine Corps., and President of Veteran Mental Health Leadership Coalition. “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.”