Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) are pushing top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
In a letter sent to the heads of the National Institutes on Health (NIH) and Food and Drug Administration (FDA) on Wednesday, the senators said that the agencies are “critical to ensuring a comprehensive, rigorous, and deliberative science-based approach to the study of psychedelics.”
That includes the “potential development of medication and therapeutics derived from these substances,” they wrote.
The senators said that they’re encouraged that NIH hosted a workshop in January to explore regulatory challenges that are impeding research into psychedelics like psilocybin and MDMA. And they want the agencies “to further expand their role in identifying research gaps, potentially promising therapeutic uses of psychedelics, and regulatory hurdles in the field of psychedelic research.”
“The United States previously conducted robust research on psychedelic drugs,” the letter says, citing the litany of early studies that were supported by government agencies and pharmaceutical companies before many of the drugs became strictly scheduled.
In the 1960s, “the counterculture movement’s embrace of psychedelics and the illicit manufacture and distribution of LSD contributed to its popular cultural rise and its increased non-medical use,” Booker and Schatz wrote. “This created a backlash resulting in its stigmatization and adverse political repercussions by the latter half of the 1960s.”
“Pharmaceutical and federal funding for psychedelic research dried up, while [Controlled Substances Act] licensure requirements made it more difficult to secure regulatory approval for research,” they said.
Schatz sent a similar letter to NIH and FDA in 2019, and the agencies did provide an update on the status of research into psychedelics, recognizing that there are possible medical uses but that additional research is needed to understand the “efficacy and long-term safety of psychedelic drugs,” for example.
But Booker’s involvement in this latest letter is notable, as the senator hasn’t previously weighed in on the issue in a significant way to date, instead focusing on his drug policy efforts largely on ending federal marijuana prohibition.
“Research on psychedelics still faces significant challenges,” the senators said. “Many major pharmaceutical companies have withdrawn or scaled back funding in this field because of the high rate of failure to find medications that are acceptable for FDA approval.”
“Research on psilocybin for severe depression and anxiety-related disorders, as well as MDMA for PTSD, is currently being supported primarily by small organizations that do not have adequate funding to develop medications through expensive safety studies and large-scale phase 3 clinical trials. A key challenge now is to design the optimal clinical trial to demonstrate efficacy, ensure safety and compliance with regulatory authorities, and secure the funding needed to support large-scale trials.”
The letter also references the Biden administration’s position on promoting research into Schedule I drugs. The White House Office of National Drug Control Policy (ONDCP) released a plan late last year that called for the streamlining of such studies.
“It is important that federal research agencies continue to assess the efficacy of potential alternatives to drugs with high misuse potential,” Schatz and Booker wrote. They added that NIH has “begun to show greater interest in psychedelic research.”
The letter lists five specific inquiries that they’re asking the agencies to respond to:
1. Please provide details on current NIH funding of psychedelic research, including a breakout by institute, and a breakout by basic versus clinical research.
2. Has NIH conducted a review of the scientific studies on psychedelics funded by NIMH and other federal entities in the period from 1950 to 1965? Was there a focus on the outcomes of those studies and the scientific limitations of those studies, as a means of informing directions of current and future NIH-funded research on psychedelic compounds? If not, would you initiate such a review?
3. What are the gaps in current psychedelic research, including questions about the methods of current clinical trials and other key scientific questions that need to be addressed to further our understanding of psychedelics?
4. What is the current status of collaboration between FDA, NIH, NIH-funded researchers and their academic institutions, and the private sector on research into psychedelics, including on identifying areas of therapeutic impact and potential medications development?
5. What are the regulatory barriers to research on psychedelics?
a) What, if any, additional regulatory barriers or requirements are there to studying natural or botanical psychedelics, such as psilocybin?
Meanwhile, the psychedelics reform movement has spread rapidly in states and localities throughout the U.S. over the past few years, following Denver’s move to become the first city in the country to decriminalize psilocybin in 2019.
Separately, a bipartisan group of members of Congress sent a letter in January that urged the Drug Enforcement Administration (DEA) to let terminally ill patients have access to psilocybin. The agency, lawmakers said, is “obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.”
Congress and 41 states have adopted right-to-try laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. Lawmakers said that DEA “has failed to abide” by the law.
More than a dozen psychedelics activists were arrested at DEA headquarters on Monday after protesting and using civil disobedience to draw attention to the issue.
DEA has increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.
Read the letter from Schatz and Booker on psychedelics research below:
Photo elements courtesy of carlosemmaskype and Apollo.