Lawmakers reintroduce bill on psychedelic therapy

Four lawmakers announced on March 7 that they had resubmitted their psychedelic therapies bill. Rep. Nancy Mace, Rep. Madeleine Dean, Sen. Cory Booker and Sen. Rand Paul introduced the Breakthrough Therapies Act, an updated bill that would amend the Controlled Substances Act (CSA) and open up access to substances like MDMA or psilocybin for medical patients.

“Breakthrough therapies give us the opportunity to improve the lives of all those living with treatment-resistant mental illness. It is our duty to ensure veterans have access to every possible treatment option that shows promise, including MDMA and psilocybin-assisted therapies,” Mace said in a press release. “This legislation will remove the bureaucratic hurdles that have hampered critical research and compassionate application of potentially life-saving therapies.”

If passed, the bill would change the CSA definition of “currently accepted medical use with severe restrictions” to “include the active ingredients in therapies that receive FDA Breakthrough Therapy Designation or Expanded Access Approval.” This would actually allow the Drug Enforcement Administration to move certain “breakthrough therapies” from Schedule I substances to the Schedule II category, which is less restrictive when it comes to medical compassionate use research and studies.

“Recent studies suggest that certain Schedule I substances, such as MDMA and psilocybin, could offer major advances in the treatment of depression, major post-traumatic stress disorder, and addiction,” Booker said. “This law will remove unduly onerous rules and regulations that prevent or delay researchers from investigating these breakthrough mental health treatments and will provide eligible patients in urgent need of care access to these promising therapies.”

The more recent version of the bill includes a section stating that substances moved from Schedule I to Schedule II could be moved back to Schedule I “if the drug no longer has a currently accepted medical use with strict restrictions and the Department of Health.” recommends that the Attorney General control the drug in Schedule I according to the subsections,” the text reads. In this case, the Attorney General would act within 90 days of receiving a letter from the Minister to issue an interim final rule.

Booker and Paul originally submitted the previous version of this bill in November 2022, but there was no progress in the Senate. Previously, Booker and Paul also introduced the “right to try” legislation in July 2022. “As a doctor, I know how important the right to try is for patients facing a life-threatening condition,” Paul said last year. “Unfortunately, the federal bureaucracy continues to block patients who wish to use Schedule I drugs under the right to try. I’m proud to lead this bipartisan legislation with Sen. Booker that will sidestep the government and free up more resources for doctors to help patients.”

The growing support for psychedelics as a medicine also provides evidence that patients may benefit. A press release from Mace explains that more than 40 organizations have supported the new law, including the Veteran Mental Health Leadership Coalition, Reason for Hope and the Special Operations Association of America. It’s also important to note that the Australian government recently announced on February 3rd that it would be moving MDMA and psilocybin to allow doctors to prescribe these substances to patients with post-traumatic stress disorder (PTSD) or treatment-resistant depression.

Many patients, especially veterans, could benefit from access to MDMA and psilocybin treatments. Additional efforts are currently being made to further research efforts into cannabis as a treatment for PTSD and chronic pain in military veterans. Senate Bill 326, or the VA Medicinal Cannabis Research Act, would require the US Department of Veteran Affairs (VA) to conduct research and submit findings to Congress about its therapeutic value.