Politics
Fentanyl Bill Signed By Trump Would Also ‘Streamline Research’ On Schedule I Drugs Like Marijuana, Congressional Analysts Say
A bill signed into law by President Donald Trump last month banning fentanyl analogues would also make a series of changes to current laws that have restricted research into Schedule I drugs like marijuana and psychedelics, congressional analysts say.
In a report published last week—shortly after Trump gave final approval to the Halt All Lethal Trafficking of (HALT) Fentanyl Act—the Congressional Research Service (CRS) broke down the various provisions, including its potential impact on studies into currently controlled substances.
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.
“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 DEA 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 brief says.
“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.”
Further, the congressional analysts explained that the HALT Fentanyl Act “does not include an expedited rescheduling provision,” unlike other legislation that’s been proposed in the past.
“DEA retains the authority to schedule, reschedule, and deschedule specific substances, including substances currently classified as FRS, through its usual regulatory scheduling process,” it says. “Congress can also change the status of FRS as a class or individually via legislation.”
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Despite the portions of the legislation that are aimed at streamlining studies on drugs, advocates have voiced concerns about the primary intent to criminalize people over a wider array of controlled substances.
Some of the research provisions of the bill are similar to those contained in a marijuana-focused measure that former President Joe Biden signed into law in 2022.
