Booker, Paul Introduce Bipartisan Legislation to Promote Research and Access to Potential Life Saving Drugs

WASHINGTON, D.C. – Today, U.S. Senator Cory Booker (D-N.J.) and U.S. Senator Rand Paul (R-KY) introduced the Breakthrough Therapies Act, legislation that would enable the Drug Enforcement Agency (DEA) to make the findings necessary to transfer breakthrough therapies involving Schedule I substances such as MDMA and psilocybin from Schedule I to Schedule II, which could help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs. Additionally, the bill would remove burdensome federal regulations that impede research and development of drugs that may be inappropriately listed in Schedule I despite their potential to save many lives.

In recent years, two substances currently classified as Schedule I drugs under the Controlled Substances Act—MDMA and psilocybin—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,” meaning that they demonstrate substantial improvement over any currently available treatments.

“Recent studies suggest that some Schedule I substances such as MDMA and psilocybin could represent an enormous advancement for the treatment of severe post-traumatic stress disorder, depression and addiction,” said Senator Booker. “Unfortunately, regulatory red tape and a series of bureaucratic hurdles involved in studying Schedule I substances impedes critical research on these and other promising Schedule I compounds. This bill reduces these unreasonably burdensome rules and regulations that delay or prevent researchers from studying – and patients from accessing – this entire class of potential medicines.”

“I’m proud to co-lead this legislation with Sen. Booker that would streamline the registration process for breakthrough therapies currently restricted by outdated drug classifications,” said Senator Paul. “This bill will make it easier for researchers to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions.”

“We urge Congress to swiftly pass the Breakthrough Therapies Act, which responsibly reduces the barriers to research and limited access of potentially life-saving treatments like MDMA- and psilocybin-assisted therapy,” said Martin R. Steele, a retired Lieutenant General in the United States Marine Corps., Chief Executive Officer of Reason for Hope, and head of the recently formed Veteran Mental Health Leadership Coalition. “Veterans should not be forced (nor should anyone else) to leave the country – at great expense – to access breakthrough therapies that can be safely provided and further studied in real-world settings here at home.”

“We believe the Breakthrough Therapies Act is the tip of the spear in our fight to ensure that Special Operations Veterans have access to the most advanced and effective medical treatments in the world,” said Daniel Elkins, Special Operations Association of America Founder and Member of the Moral Compass Federation. “The Breakthrough Therapies Act will ensure Special Operations Forces receive the care they deserve from the country they fought for.”

The text of the bill can be found here.

Reason for Hope and the Veteran Mental Health Leadership Coalition’s letter can be found here.

The Special Operations Association of America’s letter can be found here.