Bipartisan, Bicameral Breakthrough Therapies Act proposed by Mace

U.S. Rep. Nancy Mace (R-SC) this week introduced a bipartisan, bicameral bill that would eliminate burdensome rules and regulations that delay or prevent researchers from studying breakthrough mental health treatments, and would provide access to such promising therapies for eligible patients.

“This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially life-saving therapies,” said Rep. Mace on Tuesday.

The Breakthrough Therapies Act, H.R. 1393, which the congresswoman cosponsored alongside bill sponsor U.S. Rep. Madeleine Dean (D-PA), would update the Controlled Substances Act and improve access to potentially life-saving treatments for patients with mental health conditions. U.S. Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) introduced the same-named S. 689 in the Senate.

“Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses,” Rep. Mace said. “It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies.”

MDMA and psilocybin, two Schedule I drugs under the Controlled Substances Act, have shown great promise in treating a variety of mental health conditions, prompting the U.S. Food and Drug Administration (FDA) to designate both as “breakthrough therapies,” which means the drugs demonstrate substantial improvement over any currently available treatments with a clear demonstration of efficacy, according to information provided by Rep. Mace’s office. 

Despite the promising research, accessing Schedule I substances remains a major roadblock to both the research and use of breakthrough therapies, the information says. 

If enacted, the measure would address this issue by modifying and updating the law’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, among other provisions, states the information. 

“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.”

More than 40 organizations support the bill, including the Veteran Mental Health Leadership Coalition, Reason for Hope, and Special Operations Association of America.