The National Institute on Drug Abuse (NIDA) told Congress in a report obtained by Marijuana Moment that the Schedule I status of controlled substances like cannabis is preventing or discouraging research into their potential risks and benefits. It also said that current restrictions that block scientists from studying the actual cannabinoid products that consumers can purchase at dispensaries is impeding research to an extent that constitutes a public health concern.
In a document that was submitted to the House and Senate Appropriations Committees, as requested under previously enacted spending legislation, NIDA discussed “barriers to research with Schedule I substances” such as the “administratively complex” process scientists must follow in order to receive federal authorization from the Drug Enforcement Administration (DEA) to study the drugs.
“Researchers have reported that obtaining a new registration can take more than a year, that modifying a registration can also be time consuming, and that differing interpretations of the Schedule I registration requirements among local DEA field offices, research institutions, as well as distinct federal and state registration requirements, greatly complicate the process,” the federal agency told lawmakers. “These challenges can impede critical research on Schedule I substances and deter or prevent scientists from pursuing such work.”
It added that “an overarching concern expressed by researchers is a lack of transparency regarding registration requirements for Schedule I and Schedule II-V substances, and differing interpretations of those requirements by DEA field agents and research institutions.”
NIDA listed a series of issues that scientists have raised about Schedule I research barriers:
* When a drug is classified in Schedule I, that can result in “unexpected delays in ongoing research.”
* Researchers who need to change course in a study of a Schedule I substance—including something seemingly minor like adjusting the quantity being used—must re-register with DEA, causing further delays.
* Previously, just one person in a team of investigators would need to be registered with DEA. That’s apparently changed over time, with researchers telling NIDA that all members of the team require separate registration.
* DEA in some cases has required researchers to obtain multiple registrations for every physical site at which they carry out studies into Schedule I drugs, even if all the research is contained to a single campus.
* Complications surrounding access to different formulations and dosages of Schedule I drugs have also proved challenging, such and have caused confusion about whether a separate and more expensive manufacturing registration is needed for researchers whose studies require, for example, dissolving marijuana extracts in ethanol or oil before they can be used.
Researchers are currently limited to cannabis grown exclusively at the University of Mississippi.
A separate section of the report focuses specifically on “challenges associated with conducting marijuana research, which go beyond those related to the registration process” and thus deserve “separate mention in light of the increasing availability and potency of marijuana and the proliferation of new marijuana products.”
It notes that researchers are currently limited to a supply of cannabis that’s grown exclusively at the University of Mississippi, which is currently the only federally authorized marijuana manufacturer. Lawmakers and scientists have long argued that the cannabis grown at the facility is inconsistent with products available in state-legal markets, raising questions about the validity of research that depends on the government’s marijuana.
DEA said this year that it is taking steps toward approving additional applications to become federally authorized marijuana producers for research purposes. At the same time, it is proposing significant increases in the production of research-grade Schedule I drugs like marijuana, psilocybin and MDMA for 2022.
But NIDA pointed out that even while approving new manufacturers would “increase the diversity of products and formulations available to researchers,” it still wouldn’t shed light on the kinds of products that consumers are purchasing from legal markets in a growing number of states.
“Researchers supported by NIDA and other federal agencies are unable to use federal funds to purchase marijuana available through state marijuana dispensaries,” the agency said.
“Moreover, some universities have expressed reticence about allowing investigators to purchase dispensary products with non-federal funds or do research with these products on university grounds for fear of violating federal law,” it said.
“These products may differ from the actual products being sold to consumers. The inability of researchers to access marketed products may pose barriers to studying the health effects of products that individuals are using in real-world settings.”
NIDA Director Nora Volkow made similar remarks in a recent interview with Marijuana Moment, saying that she thinks “it would be theoretically ideal to understand the actual products that people are consuming, as opposed to trying to understand it with a different compound—a different plant that will vary in terms of the contents of ingredients.”
“The Committee believes we should be lowering regulatory and other barriers to conducting this research.”
Several measures to address the issue are being considered in Congress.
Last week, a bipartisan group of House members filed one such bill which, in addition to generally streamlining the research registration process, would allow scientists to study dispensary cannabis.
Late last year, the House approved an identical version of the marijuana science legislation. Days later, the Senate passed a similar bill but nothing ended up getting to the president’s desk by the end of the last Congress. Earlier this year, a bipartisan group of senators refiled their marijuana research measure for the current 117th Congress.
Meanwhile, lawmakers are also advancing a separate strategy to open up dispensary cannabis to researchers. Large-scale infrastructure legislation that has passed both chambers in differing forms and which is pending final action contains provisions aimed at allowing researchers to study the actual marijuana that consumers are purchasing from state-legal businesses instead of having to use only government-grown cannabis.
The existence of the newly revealed NIDA overview of Schedule I research barriers was made public in a Senate Appropriations Committee report attached to a spending package that was released last week.
The panel expressed concerns about “restrictions associated with Schedule I of the Controlled Substance Act which effectively limits the amount and type of research that can be conducted on certain Schedule I drugs, especially opioids, marijuana or its component chemicals and new synthetic drugs and analogs.”
“At a time when we need as much information as possible about these drugs and antidotes for their harmful effects, the Committee believes we should be lowering regulatory and other barriers to conducting this research,” it said.
However, the committee said it “appreciates NIDA’s completion of a report on the barriers to research that result from the classification of drugs and compounds as Schedule I substances including the challenges researchers face as a result of limited access to sources of marijuana including dispensary products.”
Read NIDA’s report on Schedule I research barriers below:
Photograph via National Institute on Drug Abuse