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Senator Cory Booker and Rand Paul just filed a research bill that would force the DEA to reschedule the Schedule I substances granted “Breakthrough Therapy” status to Schedule II, while also removing research barriers for tightly controlled substances, according to Marijuana Moment.
The bill is called the “Breakthrough Therapies Act,” and it was filed on Thursday, Nov. 17 — the same day that bipartisan House lawmakers announced the formation of a congressional psychedelics caucus. This meeting is meant to nurture the development of novel treatments derived from Schedule I psychedelics.
The bill aims to revise the Controlled Substances Act (CSA), a piece of draconian legislation that dictates the drug laws in the US. The Breakthrough Therapies Act creates a procedure that would make Schedule I drugs — such as MDMA, DMT, or psilocybin — 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 to make them easier to study. The goal is to promote drug development.
As soon as any drug receives a breakthrough therapy designation or qualifies for the FDCA waiver, the administrative process would force the DEA to make it a Schedule II. The Schedule II classification is comprised of drugs with “accepted medical use [but] severe restrictions.” These drugs include fentanyl, cocaine, and methamphetamine to name a few.
Some of the other major facets of the bill are borrowed from provisions of previous legislation meant to expedite and simplify research into Schedule I drugs. That would cover most of the classic psychedelics, cannabis, and other controlled substances.
Scientists and lawmakers continue to point out the legal barriers that hinder studying Schedule I drugs, describing them as excessively burdensome and limiting to vital research. Given how quickly psychedelic-assisted therapy is coming to market, we still don’t know enough about how these drugs impact the brain and body in the short or long term. Hell, we still don’t scientifically understand why and how we trip balls, either.
If it passes, the Booker-Paul bill would give researchers with existing Schedule I or II registrations with DEA the ability to study Schedule I drugs within 30 days of sending a notice to the attorney general. Scientists without such registration on file would be able to petition DOJ for permission to do so, and receive one within 45 days if they provide the required information about their research project.
Additionally, the bill would also make it possible for multiple researchers at a given institution be able to participate under a single registration. Should a research institute studying Schedule I drugs take place in multiple locations, such as the format for the MAPS MDMA trials, the bill would only require one overall registration instead of having 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 impede 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 introduced separate legislation in July, known as the “Right to Try.” These laws would give seriously ill patients access to Schedule I drugs, including marijuana and psilocybin.
A month ago, Booker stated that the intent of the 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 the Right To Try 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 than 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.”
