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

Seeks to update the Controlled Substances Act and improve access to lifesaving treatments for patients 

Washington, D.C. - Today, Rep. Nancy Mace and Madeleine Dean, with Senators Rand Paul and Cory Booker, introduced the Breakthrough Therapies Act, which looks to update the Controlled Substances Act and improve access to potentially lifesaving treatments for patients with mental health conditions.

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

“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.

“As our nation faces mental health and substance use disorder crises, Congress has a role to play to ensure that our loved ones, including our veterans, have access to treatment options,”said Rep. Dean.“Our bipartisan legislation reduces barriers that will enable better research and compassionate use of two innovative and potentially lifesaving treatments — MDMA and psilocybin. We must always work to break stigma and help make recovery possible for more people.”

Background:

 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.

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ABOUT

Congresswoman Nancy Mace represents SC-01. She grew up in the Lowcountry. Before being sworn into Congress, Nancy earned accolades as one of the most fiscally conservative members of the South Carolina General Assembly; she’s also one of the most pro-conservation lawmakers in South Carolina. Nancy is the recipient of the 2019 Taxpayer Hero Award from the South Carolina Club for Growth; she has a 100% record of voting to lower taxes. Nancy also has a 100 percent rating with Conservation Voters of South Carolina.

Media Contact: 

SC01press@mail.house.gov