Four legislators announced on March 7 that they have refiled their psychedelic therapy bill. Rep. Nancy Mace, Rep. Madeleine Dean, Sen. Cory Booker, and Sen. Rand Paul introduced the Breakthrough Therapies Act, an updated bill that would amend the Controlled Substances Act (CSA) and open up access to substances such as MDMA or psilocybin for medical patients.

“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 Mace in a press release. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”

If passed, the bill would amend the CSA’s definition of “currently accepted medical use with severe restrictions” to “include the active ingredients of therapies that receive an FDA Breakthrough Therapy Designation or Expanded Access approval.” In effect, this would allow the Drug Enforcement Administration to move certain “breakthrough therapies” of Schedule I substances into the Schedule II category, which is less restrictive when it comes to research and studies regarding medical compassionate use.

“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 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.”

The newer version of the bill includes a section stating that substances that move from Schedule I to Schedule II could be moved back to Schedule I “if the drug no longer has a currently accepted medical use with severe restrictions and the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule I pursuant to subsections,” the text states. In that case, the Attorney General would act within 90 days of receiving a letter from the Secretary to issue an interim final rule.

Originally, Booker and Paul filed the previous version of this bill in November 2022, but it did not receive any progress in the Senate. Previously, Booker and Paul also introduced “Right to Try” legislation in July 2022. “As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” said Paul last year. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”

The growing support of psychedelics as medicine also lends evidence that patients could benefit from it. A press release from Mace explains that more than 40 organizations have come out in support of the new bill, such as Veteran Mental Health Leadership Coalition, Reason for Hope, and Special Operations Association of America. It’s also important to mention that the Australian government recently announced on Feb 3 that it would be rescheduling MDMA and psilocybin to allow physicians to prescribe those substances to patients suffering from post-traumatic stress disorder (PTSD) or treatment-resistant depression.

Many patients could benefit from access to MDMA and psilocybin treatments, especially veterans. There are other efforts currently underway to help boost research efforts for cannabis as a way to treat PTSD and chronic pain in military veterans. Senate Bill 326, or the VA Medicinal Cannabis Research Act, would require that the U.S. Department of Veteran Affairs (VA) conduct research and report findings to congress regarding its therapeutic value.

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Officials in Berkeley, California are set to consider a proposal that would decriminalize psychedelics, including LSD.

The measure is a byproduct of a years-long project that has “lingered for three years in the Berkeley City Council,” according to Berkeleyside, which added that the council is set to “come back to life in a few weeks.”

What distinguishes Berkeley’s proposal from other communities that have moved to legalize hallucinogens is that the northern California city would represent “an even broader proposal: one that could make it the first in the U.S. to decriminalize LSD,” according to Berkeleyside.

“Of the 15 U.S. cities that have softened restrictions on psychedelics, none has included this synthetic hallucinogen. Berkeley Community Health Commissioners Joseph Holcomb Adams and Karma Smart explained that the logic for decriminalizing LSD is that it meets the technical definition of psychedelics,” Berkeleyside reported.

“Berkeley’s resolution was initially drafted by the Oakland-based nonprofit Decriminalize Nature in 2019, and proposed decriminalizing only natural psychedelics, such as psilocybin mushrooms, ayahuasca, and mescaline cacti,” the outlet continued. “The resolution spent two years in the hands of the city’s Community Health Commission (CHC), one of 22 civil commissions advising the City Council. Over the last year, Adams and Smart, the two commissioners appointed to study it, entirely rewrote it. If approved by the City Council, the personal consumption of psychedelics will cease to be criminalized in Berkeley; sharing, giving, or distributing psychedelics will, however, continue to be crimes.”

According to NBC Bay Area, Berkeley “city health commissioners voted unanimously to recommend to the city council decriminalize the use of hallucinogens.”

The legalization and decriminalization of hallucinogens has emerged as the latest frontier in the United States’ drug reform movement. 

Earlier this month, U.S. Sens. Cory Booker, a Democrat, and Rand Paul, a Republican, introduced a bill requiring the Drug Enforcement Administration (DEA) to classify therapies involving psilocybin and MDMA in order to improve access for patients and researchers. 

“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. “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.”

Paul said he was proud to co-lead this legislation, which is known as the Breakthrough Therapies Act, 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,” Paul said in a statement. 

The legislation has won the endorsement of Martin R. Steele, a retired United States Marine Corps lieutenant general who leads the Veteran Mental Health Leadership Coalition.

“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.”

Should the bill pass and become law, it would force the DEA to reschedule the aforementioned substances under the Controlled Substances Act. 

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