Attorney General Pam Bondi has missed a congressionally mandated deadline to issue guidelines for easing barriers to research on Schedule I substances such as marijuana and psychedelics.
Under legislation passed by lawmakers and signed into law by President Donald Trump last year, Bondi was supposed to publish interim rules setting out new processes for Schedule I research registration by January 16—but that has not occurred.
“This failure to act leaves researchers, institutions and regulators without clear guidance and directly contributes to research harm—the preventable damage caused when restrictive or unclear drug policies obstruct legitimate scientific research,” Kat Murti, executive director of Students for Sensible Drug Policy (SSDP), said in a press release on Tuesday. “Research harm delays medical innovation, limits evidence-based policymaking and slows the development of potential treatments for overdose, pain, addiction and mental health conditions.”
“Congress gave the attorney general a clear deadline and a clear mandate: reduce barriers to research while ensuring transparency and public input,” Murti said. “Missing this deadline is not a neutral administrative failure—it actively perpetuates research harm. When scientists are left navigating vague or contradictory rules, lifesaving research is delayed, innovation stalls and public health suffers.”
While drug policy reform advocates have sounded the alarm about the main thrust of the bill, which is to permanently place analogues of the opioid fentanyl into Schedule I of the Controlled Substances Act (CSA), there are components that could help facilitate studies into drugs, including cannabis, psilocybin, MDMA and others.
The Congressional Research Service (CRS) broke down the various provisions of the law—the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act)—in a report last year, including its potential impact on studies into currently controlled substances.
“Section 3 of the HALT Fentanyl Act contains multiple provisions designed to streamline research with Schedule I controlled substances,” CRS said. “The section applies generally to Schedule I substances, including but not limited to [fentanyl-related substances, or FRS.]”
It would do so by amending statute in a way that creates a “simplified registration process for researchers whose research” is funded by the U.S. Department of Health and Human Services (HHS) or the U.S. Department of Veterans Affairs (VA), for example.
The revised registration process would also apply to entities studying Schedule I drugs under an Investigational New Drug (IND) exemption from the Food and Drug Administration (FDA).
“Under the new process, the researcher may submit a notice to [the Drug Enforcement Administration] containing the controlled substance to be used in the research, the quantity of the substance to be used, demonstration that one of the above criteria is met (e.g., the grant or project number and identification of the funding agency or the IND application number), and demonstration that the researcher is allowed to do the research under the law of the state where the research will be conducted,” the CRS report said.
“Researchers currently registered to conduct research with Schedule I or II controlled substances may begin their new research within 30 days of the notice to DEA,” it says. “For a researcher without a current registration, DEA must act within 45 days of receiving all required information either to register the applicant or issue an order for the applicant to show cause why registration should not be denied.”
Another change under the new law makes it so DEA-registered researchers will not have to obtain a separate registration for a Schedule I drug “if the manufactured quantities are small and are produced for purposes of the research and the researcher notifies DEA of the manufacturing activities and the quantities of the substance in question.”
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