A group of federal lawmakers seeks to remove regulatory barriers that inhibit psychedelics in research and compassionate use cases.

Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) introduced an updated version of the Breakthrough Therapies Act to the Senate. If passed, the bill would make it easier to use Schedule 1 drugs with a breakthrough therapy designation.

Specifically, it would allow drugs, including MDMA and psilocybin, which have the breakthrough designation, to be transferred from a Schedule I to Schedule II drug, enabling more patient access and more 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,” Booker said in a statement. “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.”

A version of the legislation will also be introduced into the House by Representatives Nancy Mace (R-SC) and Madeleine Dean (D-PA).

Psychedelics in research

Several new studies have demonstrated the positive impacts of psychedelic-assisted treatment. For example, JAMA published a study in August, which showed patients with alcohol use disorder (AUD) that received psilocybin-assisted treatment, lowered their percentage of heavy drinking days significantly.

Additionally, the Multidisciplinary Association for Psychedelic Studies’ (MAPS) ongoing research on psychedelics treatment for PTSD has been lauded by industry insiders as a pivotal trial. MAPS finished its second Phase 3 trial on MDMA to support the substance’s FDA approval in 2022. MAPs anticipates that MDMA-assisted therapy will land an FDA evaluation by the end of the year. MAPS currently has an FDA breakthrough designation for its treatment.

In MAPS’ first Phase 3 study of MDMA, researchers found that 88% of participants with severe PTSD taking MDMA significantly reduced their symptoms, compared to 60% of placebo patients.

“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,” Mace said. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”