Four legislators announced on March 7 that they have refiled their psychedelic therapy 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 such as MDMA or psilocybin for medical 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,” said Mace in a press release. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”
If passed, the bill would amend the CSA’s definition of “currently accepted medical use with severe restrictions” to “include the active ingredients of therapies that receive an FDA Breakthrough Therapy Designation or Expanded Access approval.” In effect, this would allow the Drug Enforcement Administration to move certain “breakthrough therapies” of Schedule I substances into the Schedule II category, which is less restrictive when it comes to research and studies regarding medical compassionate use.
“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 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.”
The newer version of the bill includes a section stating that substances that move 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 severe restrictions and the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule I pursuant to subsections,” the text states. In that case, the Attorney General would act within 90 days of receiving a letter from the Secretary to issue an interim final rule.
Originally, Booker and Paul filed the previous version of this bill in November 2022, but it did not receive any progress in the Senate. Previously, Booker and Paul also introduced “Right to Try” legislation in July 2022. “As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” said Paul last year. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”
The growing support of psychedelics as medicine also lends evidence that patients could benefit from it. A press release from Mace explains that more than 40 organizations have come out in support of the new bill, such as Veteran Mental Health Leadership Coalition, Reason for Hope, and Special Operations Association of America. It’s also important to mention that the Australian government recently announced on Feb 3 that it would be rescheduling MDMA and psilocybin to allow physicians to prescribe those substances to patients suffering from post-traumatic stress disorder (PTSD) or treatment-resistant depression.
Many patients could benefit from access to MDMA and psilocybin treatments, especially veterans. There are other efforts currently underway to help boost research efforts for cannabis as a way to treat PTSD and chronic pain in military veterans. Senate Bill 326, or the VA Medicinal Cannabis Research Act, would require that the U.S. Department of Veteran Affairs (VA) conduct research and report findings to congress regarding its therapeutic value.