Republican lawmakers in the House and Senate have introduced new legislation that would make it easier for scientists to research Schedule I drugs like marijuana and psilocybin.
Companion bills filed by Sen. Bill Cassidy (R-LA) and Rep. Morgan Griffith (R-VA) largely reflect a plan that was recently released by the White House’s Office of National Drug Control Policy (ONDCP), with the backing of the Drug Enforcement Administration (DEA).
Titled the Halt All Lethal Trafficking of (HALT) Fentanyl Act, the main intent of the identical companion measures is to curb trafficking of the powerful opioid. While reform advocates have expressed concern about provisions that would permanently place fentanyl analogues in the strictest federal drug category, the legislation also contains provisions to streamline the research process for all Schedule I drugs under the Controlled Substances Act. That strict category currently includes cannabis as well as psychedelics like LSD, mescaline and MDMA.
The bills would facilitate studies in part by aligning the research requirements for Schedule I drugs with those of the less-restricted Schedule II. Scientists and lawmakers have consistently pointed out that the existing rules for studying Schedule I controlled substances are excessively burdensome, limiting vital research.
Rather than having each scientist involved in a Schedule I drug study obtain DEA registration, the GOP lawmakers and White House want to make it so multiple researchers at a given institution would be allowed to participate under a single registration.
They also proposed a policy change where a research institute with studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.
Another change would allow certain researchers to move ahead with conducting their studies after submitting a notification to the Department of Justice instead of waiting for officials to affirmatively sign off on their proposals.
The plan would also waive the requirement for additional inspections at research sites in some circumstances and allow researchers to manufacture small amounts of drugs without obtaining separate registrations. The latter component would not allow cultivation of marijuana, however.
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Griffith said in a press release that the legislation “would recognize the danger of fentanyl related substances by permanently scheduling them while also allowing researchers to study their effects.”
It’s important to include that research component because “one of the things we’ve done in the past is we’ve put things on Schedule I and then we’ve not researched it,” the congressman said at a briefing, seemingly alluding to cannabis.
“There may be potential out there” for the therapeutic use of fentanyl analogues, he said. “It’s got to be done carefully. It’s got to be done in the way that we’ve set it up so that we have the protections there. But we may find something good as part of the research.”
When ONDCP first announced its proposed Schedule I policy changes in September, some experts tempered expectations about the practical effects of aligning Schedule I and Schedule II applications. The difference is largely a matter of extra paperwork for the more restrictive category, they contend.
At a House hearing earlier this month, DEA and National Institute on Drug Abuse (NIDA) officials endorsed the idea of making it easier to research Schedule I drugs.
The White House’s intent to streamline research into Schedule I drugs has been notable and seems to be part of a theme that developed within the administration.
For example, DEA has repeatedly proposed significant increases in the production of marijuana, psilocybin and other psychedelics for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications.
NIDA Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s prior proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
Volkow, who heads the nation’s top drug research agency, even said that she personally hesitates to study cannabis because of Schedule I research barriers.
Still, advocates remain frustrated that these plants and fungi remain in the strictest drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
There has been at least one recent development in the fight to modernize marijuana research. President Joe Biden signed a massive infrastructure bill last month that includes provisions aimed at allowing researchers to study the actual cannabis that consumers are purchasing from state-legal dispensaries instead of having to use only government-grown cannabis.
But that’s just one of numerous research barriers that scientists have identified. A report that NIDA recently submitted to Congress stressed that the Schedule I status of controlled substances like marijuana is preventing or discouraging research into their potential risks and benefits.
Last Congress, the House and Senate approved separate bills with the shared objective of promoting marijuana research.
The Senate’s measure would have streamlined the application process for researchers who want to study cannabis and to encouraged the Food and Drug Administration (FDA) to develop cannabis-derived medicines.
Sens. Dianne Feinstein (D-CA) and Brian Schatz (D-HI), chief sponsors of that legislation, which was not ultimately enacted, also tried to get the reform passed as an amendment to a defense spending bill this month. The amendment didn’t make the cut, however.
The House bill that passed last year would have established a simplified registration process for researchers interested in studying cannabis, in part by reducing approval wait times, minimizing costly security requirements and eliminating additional layers of protocol review.
The U.S. Department of Health and Human Services (HHS) and the attorney general would have been required under the bill to create a process for marijuana manufacturers and distributors to supply researchers with cannabis from dispensaries.