Attorney General Misses Deadline For Rules To Make It Easier To Study Schedule I Drugs Like Marijuana And Psychedelics

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.”

“It allows for the creation of different forms of the substance consistent
with the research and further allows dosage form development studies to be
performed in order to apply to FDA for an IND exemption,” CRS said, while
noting that the section “also specifies that it does not provide authority
to grow marijuana.”

But advocates say the streamlining of research can only occur if the
attorney general follows through and issues new guidelines for implementing
the law.

“These provisions have the potential to reduce research harms—but only if
they are implemented clearly, consistently, and in consultation with the
scientific community,” Dr. Alaina Jaster, Ph.D., pharmacologist and
toxicologist and Co-Chair of SSDP’s Science Policy Committee, said.
“Without guidance, confusion and delay are inevitable.”

Trump also issued an executive order last month directing Bondi to quickly
complete the process of moving marijuana from Schedule I of the CSA to
Schedule III, but that has not yet occured.

The post Attorney General Misses Deadline For Rules To Make It Easier To
Study Schedule I Drugs Like Marijuana And Psychedelics appeared first on Marijuana
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