Analysts say that the bill, signed by Donald Trump in December and banning analogues of fentanyl, would make changes to existing laws which have limited research on Schedule I drugs such as marijuana and psychedelics.
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 the drug reformers have raised concerns about the major thrust of the legislation, which is the permanent inclusion of analogues of fentanyl as Schedule I substances under the Controlled Substances Act(CSA), the bill also contains components that can help to facilitate the study of drugs such as cannabis, psilocybin MDMA, and other types of drugs.
CRS stated that Section 3 of HALT Fentanyl contains several provisions to facilitate research on Schedule I controlled substances. This section covers all Schedule I controlled substances. [fentanyl-related substances, or FRS.]”
This would be done by amending the statute to create a “simplified process” for researchers who are funded by, for instance, the U.S. Department of Health and Human Services or Department of Veterans Affairs.
It would be applicable to all entities researching Schedule I medications under the Food and Drug Administration’s (FDA) Investigational New Drug (IND), as well.
According to the CRS, “Under the New Process, the Researcher may submit a Notice to DEA containing a list of controlled substances to be employed in research and their quantity, as well a demonstration of one or more of the criteria above (e.g. grant or project numbers and identifications of funding agencies, or IND application numbers) and if the researcher can demonstrate that he is permitted to carry out the research according to the law where it will take place.”
Researchers who are currently registered for research on Schedule I or II controlled drugs may start their new research in 30 days after receiving the notice from DEA. For a researcher who does not have a registration at the time, DEA has 45 days to act either by registering the researcher or issuing an order to the applicant for them to prove why they should be registered.
A new change in the law allows researchers registered with the DEA to not need a separate registration if they are producing small quantities for research purposes and notifying the DEA about the activities of manufacturing and quantities.
CRS stated that “it allows the creation of different dosage forms consistent with research, and allows further development studies of dosage forms to be done in order to submit an IND exemption to FDA,” while noting the “also specifying that it does NOT provide authority to cultivate marijuana.”
The congressional analysts also explained that unlike previous legislation, the HALT Fentanyl Act does not “include an expedited scheduling provision.”
The DEA has the right to schedule, reschedule and deschedule substances through its normal regulatory scheduling procedure, which includes substances classified currently as FRS. Congress may also amend the classification of FRS, either as a whole or in individual cases.
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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.
Several of the provisions in this bill that relate to research are the same as those found in the measure focusing on marijuana which former President Joe Biden passed into law in 2020.
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