A bipartisan duo of U.S. senators introduced legislation on Thursday that would require the Drug Enforcement Administration (DEA) to reclassify breakthrough therapies such as the psychedelics psilocybin and MDMA to ease access for patients and streamline research into the promising drugs. The bill, titled the Breakthrough Therapies Act, was introduced by Democratic Senator Cory Booker of New Jersey and Senator Rand Paul, a Republican from Kentucky.
After introducing the legislation, the senators noted that the psychedelics MDMA and psilocybin, both Schedule I drugs, have in recent years shown great promise as treatments for a range of mental health conditions including treatment-resistant suicidal depression, anxiety, PTSD, and substance use disorders. Preliminary research into the compounds has been so encouraging that the Food and Drug Administration has recently classified both MDMA- and psilocybin-assisted therapies as “breakthrough therapies,” a designation signifying 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,” Booker said in a statement from the senator’s office on Thursday. “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.”
Bill Requires DEA To Reschedule Breakthrough Therapies
If passed into law, the Breakthrough Therapies Act would require the 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 under the federal Controlled Substances Act. The lawmakers maintain that the legislation “could help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs.” The bill would also remove federal regulations that impede research into compounds that have been listed as Schedule I substances despite their potential to save lives, including drugs classified as breakthrough therapies by the FDA.
“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 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.”
Martin R. Steele, a retired United States Marine Corps lieutenant general and the CEO of the nonprofit Reason for Hope, leads the Veteran Mental Health Leadership Coalition, a group advocating for broader access to psychedelic therapies for U.S. military veterans. In a letter from the two groups, he called on lawmakers to approve the legislation introduced by Booker and Paul on Thursday.
“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 Steele. “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 letter was cosigned by nearly two dozen veterans services and mental health advocacy organizations including Veterans Exploring Treatment Solutions (VETS), Black Therapists Rock, The Hope Project, and others.
“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 a 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.”
Noting the bipartisan nature of the legislation, Shane Pennington, an attorney at the psychedelics and cannabis law firm Vicente Sederberg LLP, said that “this is a fantastic bill that everyone should support regardless of political affiliation.”
“Drugs that FDA has given breakthrough therapy designation shouldn’t be in schedule I, and vets (and others) shouldn’t have to go to other countries to get them,” Pennington wrote in an email to High Times. I applaud Senators Booker and Paul for this one.”