Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill on Thursday that would require the Drug Enforcement Administration (DEA) to transfer breakthrough therapies like psilocybin and MDMA from Schedule I to II, while also removing research barriers for strictly controlled substances.
The “Breakthrough Therapies Act” was filed on the same day that bipartisan House lawmakers announced the formation of a congressional psychedelics caucus that’s meant to promote the development of novel treatments derived from currently controlled entheogenic substances.
The new Senate legislation proposes to make a series of amendments to the federal Controlled Substances Act (CSA), including by creating a procedure through which current Schedule I drugs that are deemed breakthrough therapies by the Food and Drug Administration (FDA) or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA) could be transferred to a lower schedule that would make them easier to study and promote drug development.
As soon as any drug receives a breakthrough therapy designation or qualifies for the FDCA waiver, that would trigger the administrative process for DEA to place it in Schedule II, which is reserved for drugs with “currently accepted medical use with severe restrictions.”
The other key components of the bill are largely borrowed from provisions of previous standalone legislation that are meant to simplify and expedite research into Schedule I drugs, which would cover certain psychedelics, as well as marijuana and other controlled substances.
Scientists and lawmakers have consistently pointed out that the existing statutes on studying Schedule I controlled substances are excessively burdensome, limiting vital research.
To help resolve that, the Booker-Paul bill would make it so researchers with existing Schedule I or II registrations with DEA would be able to carry out studies into Schedule I drugs within 30 days of sending a notice to the attorney general. Scientists without such a registration on file would be able to petition DOJ for a registration and receive one within 45 days if they provide required information about their research project.
Additionally, rather than having each scientist involved in a Schedule I drug study obtain DEA registration, it would make it so multiple researchers at a given institution would be allowed to participate under a single registration. And a research institute with Schedule I studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.
“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 press release. “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,” the senator, who posted a video late last month similarly touting the therapeutic benefits of psychedelics, said.
Paul said that he’s “proud to co-lead this legislation with Sen. Booker that would streamline the registration process for breakthrough therapies currently restricted by outdated drug classifications.”
“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,” the senator said.
Booker and Paul previously introduced separate legislation in July to clarify that federal “Right to Try” (RTT) laws give seriously ill patients access to Schedule I drugs, including marijuana and certain psychedelics.
Booker said last month that that the intent of that bill was to “open up more avenues to take drugs that are now banned and make them accessible, especially for people that are suffering.”
The earlier bill would make a technical amendment to the text of the existing statute, but the primary purpose is to clarify that RTT policy as signed into law by former President Donald Trump already means that patients with terminal health conditions can obtain and use investigational drugs that have undergone clinical trials, even if they’re Schedule I controlled substances.
This latest bipartisan legislation goes further that providing clarification, however.
“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,” Martin Steele, a retired Marine and CEO of Reason for Hope, said of this latest legislation. “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.”
Meanwhile, Reps. Lou Correa (D-CA) and Jack Bergman (R-MI) announced on Thursday that they’d formed what’s being called the Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus, which will “focus on exploring psychedelic research to alleviate the U.S. mental health crisis.”
These developments come amid a wave of local reform efforts—and just one week after Colorado voters approved a historic ballot initiative to legalize the possession of certain entheogenic substances and create psilocybin “healing centers” in the state.
Correa has been one of the earliest advocates for psychedelics research in Congress, supporting amendments to facilities studies into the substances and requesting spending bill report language that was adopted earlier this year that calls for a Government Accountability Office (GAO) analysis on barriers to state, local and tribal programs for the psilocybin.
He said last year that psychedelics can “help veterans deal with those invisible wounds that they bring back from the battlefield—PTSD and other mental issues that they bring back with them and carry with them on a day to day basis.”
The psychedelic law reform movement started in earnest at the local level, beginning with Denver historic 2019 vote to decriminalize psilocybin mushrooms. Activists and lawmakers in cities across the U.S.—from Seattle to Detroit—have since followed suit.
State legislatures and governors have also approved measures meant to promote research into entheogenic plants and fungi in recent years, including those as ideologically distinct as Connecticut and Texas. And the conversation has increasingly picked up in the halls of Congress, too.
National Institute on Drug Abuse (NIDA) Director Nora Volkow has long criticized the unique research barriers that are imposed on scientists interested in studying Schedule I drugs such as cannabis and psychedelics, saying that she personally avoids taking on such projects given those difficulties.
She also said at the beginning of the year that the “train has left the station” on psychedelics, as people are going to keep using substances such as psilocybin—especially as the reform movement expands and there’s increased attention being drawn to the potential therapeutic benefits.
Advocates have been encouraged by the gradually growing interest in psychedelics policy and science issues within Congress.
Rep. Earl Blumenauer (D-OR) told Marijuana Moment late last month that he “absolutely” sees parallels between the movements to reform laws around psychedelics and marijuana. He also accurately predicted the Colorado voters would approve the psychedelics legalization initiative at the ballot last week.
The congressman is well known for his marijuana reform advocacy on Capitol Hill, serving as a co-chair of the Congressional Cannabis Caucus. But he’s also become one of the most vocal members on psychedelics policy in recent years as his home state of Oregon has led the way in legalizing psilocybin services access and more broadly decriminalizing drug possession.
Blumenauer also recently spoke about the therapeutic potential of psychedelics during a congressional committee markup, saying the substances hold “real potential” as alternative mental health therapies with “less impact” than traditional pharmaceuticals.
He suggested that psychedelics policy should be part of the larger conversation about health care improvements, noting his interest in giving terminally ill patients access to investigative drugs like psilocybin, for example.
At the beginning of this year, Blumenauer led a bipartisan letter requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution under federal RTT law.
In July, the House voted in favor of two psychedelics-related amendments to a defense bill, including one that would require a study to investigate psilocybin and MDMA as alternatives to opioids for military service members and another that would authorize the defense secretary to provide grants for studies into several psychedelics for active duty service members with PTSD.
But while advocates are encouraged by these incremental developments amid the national psychedelics decriminalization movement, some lawmakers feel that Congress isn’t keeping pace with the public and the science.
Rep. Jared Huffman (D-CA) told Marijuana Moment recently that he’s done his research and believes that natural plants and fungi like psilocybin can be a therapeutic “game changer,” but he said that it’s “embarrassing” how slow other federal lawmakers have been to evolve on the issue.
The U.S. Department of Health and Human Services (HHS) recently said that it is actively “exploring” the possibility of creating a task force to investigate the therapeutic of certain psychedelics like psilocybin and MDMA in anticipation of federal approval of the substances for prescription use.
That came in response to letters from bipartisan congressional lawmakers, state legislators and military veterans, who implored the HHS secretary to to consider establishing an “interagency taskforce on the proper use and deployment of psychedelic medicine and therapy.”
For its part, DEA said last month that it want to more than double the amount of marijuana that can be legally manufactured for research in 2023—and it’s also seeking to significantly increase the quota for the production of psychedelics like psilocyn, LSD and mescaline.
A top Canadian health official who heads up the country’s efforts to combat addiction recently visited Colorado, Oregon and Washington State to learn about their experiences implementing drug policy reform like broad decriminalization and harm reduction—meeting with the governor of Oregon and psychedelics activists, among others, on a week-long tour.
Read the text of the new Senate psychedelics and Schedule I research bill below: