Booker, Paul, Mace, Dean 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 an updated version of the Breakthrough Therapies Act. This legislation will remove regulatory hurdles that inhibit research and compassionate use access to potentially lifesaving treatments that are heavily restricted by Schedule I of the Controlled Substances Act. U.S. Representatives Nancy Mace (R-SC) and Madeleine Dean (D-PA) introduced companion legislation in the House of Representatives.

In recent years, two substances currently classified as Schedule I drugs—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 MDMA- and psilocybin-assisted therapies as “breakthrough therapies,” meaning that they demonstrate substantial improvement over any currently available treatments.

However, due to the Schedule I status of MDMA and psilocybin, unnecessary red tape hinders critical research and access to treatment even for patients with terminal or life-threatening conditions. The Breakthrough Therapies Act would resolve these problems by expediting the transfer of substances that receive breakthrough therapy designation from Schedule I to Schedule II, which – with DEA oversight – will enable patient access and reduce the burden on further clinical investigation.

“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.

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

“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 Representative 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.”

“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., and President of 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.”

“The Breakthrough Therapies Act is a common-sense solution to a clear problem,” said Brett Waters, an attorney and Executive Director of Reason for Hope. “We thank Senators Booker and Paul and Congresswomen Dean and Mace for their bipartisan leadership to remove the red tape slowing down research and hindering access to breakthrough mental health treatments. This bill will help save lives and responsibly usher in a new paradigm of mental health care.”

“We have seen the evidence that treatments like MDMA- and psilocybin-assisted therapies can work miraculously for otherwise treatment-resistant forms of depression and PTSD,” said Lt. Diane Goldstein (Ret.), Executive Director of the Law Enforcement Action Partnership. “There are thousands of law enforcement officers around the country who would benefit from these life-saving interventions. Healthier police officers lead to healthier outcomes for our communities. Congress needs to pass the bipartisan Breakthrough Therapies Act.”

“Affinity Healthcare Advocates is pleased to join this coalition promoting alternative therapies for physical and mental health. The 9/11 Community, like Veterans, needs new more effective paths to healing,” said Anne-Marie Principe, Director, Affinity Healthcare Advocates.

“How anyone could oppose removing bureaucratic obstacles to doctors providing breakthrough mental health treatments for terminal cancer patients struggling with end-of-life anxiety, which can be safely administered under medical supervision, is beyond comprehension,” said Dr. Sue Sisley, principal investigator at Scottsdale Research Institute.

“I am grateful to the bill sponsors who are able to see beyond stigma-based misinformation and prioritize the precious lives of Americans. Although it’s too late for my son, actions like this give me hope that we are moving toward a more compassionate country that cares for those who are suffering,” said Susan Ousterman, Founder of Villomah Memorial Foundation.

“The REID Foundation takes pride in endorsing The Breakthrough Therapies Act and its sponsors’ efforts to offer hope and healing to individuals in need,” said Ryan Rodgers, Executive-Director, REID Foundation. “Substances such as MDMA and Psilocybin have demonstrated remarkable efficacy in addressing PTSD and various mental health concerns. It is time for Congress to pass this life saving act and reduce the barriers to research.”

Reason for Hope’s letter of support can be found here.

Veteran Mental Health Leadership Coalition’s letter of support can be found here.

The text of the bill can be found here.