Rep. Mace & Dean with Sen. Booker & Paul Introduce Breakthrough Therapies Act for Veterans and Patients

“Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses,” said Rep. Mace. “It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies. This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”

Senator Booker echoed her sentiment.

“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,” he 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.”

Background from Rep. Mace’s office:

MDMA and psilocybin, two Schedule I drugs under the CSA, 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 both MDMA- and psilocybin-assisted therapies as “Breakthrough Therapies,” a designation meaning they demonstrate substantial improvement over any currently available treatments with a clear demonstration of efficacy.

Recent research in the United States and the UK has demonstrated the significant medical benefits of psilocybin and MDMA. Phase 2b trial results published in The New England Journal of Medicine showed that one small dose of psilocybin used in medication-assisted therapy caused the remission of treatment-resistant depression in about 30% of patients. Similarly, a 2020 study involving the National Center for PTSD using MDMA found that patients who had served in Operation Enduring Freedom and Operation Iraqi Freedom experienced “significant and very large” reductions in suicidal thoughts, PTSD, depression, and anxiety.

The Breakthrough Therapies Act would:

Despite the promising research, accessing Schedule I substances remains a significant roadblock to critical research and the compassionate use of breakthrough therapies. The Breakthrough Therapies Act aims to address this issue by updating 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. By modifying this definition, the DEA would begin making the findings necessary to transfer breakthrough therapies involving Schedule I substances to Schedule II for limited research and medical compassionate use.

This legislation also creates an expedited process for the DEA to transfer an Expanded Access drug from Schedule II back to Schedule I if the drug is placed on clinical hold. The DEA’s findings could help facilitate a phased roll-out of potentially lifesaving therapies via compassionate use pilot programs. In the case of psilocybin- and MDMA-assisted therapies, these programs would help veterans and other patients manage PTSD & depression and prevent suicide.

Support:

Over 40 organizations have announced their support for this bill, including the Veteran Mental Health Leadership Coalition, Reason for Hope, and Special Operations Association of America. On February 3, 2023, the Australian government announced a rescheduling of MDMA and psilocybin, permitting authorized psychiatrists to prescribe them for PTSD and treatment-resistant depression, respectively, subject to controls over prescribing rights and treatment protocols. The decision acknowledged the current lack of options for patients with specific treatment-resistant mental illnesses.