Experts Reflect on What New Law Might Mean for Cannabis Research

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President Joe Biden in December 2022 signed into law the bipartisan Medical Marijuana and Cannabidiol Research Expansion Act (HR 8454). The legislation is designed to streamline access to marijuana and marijuana-derived chemicals such as tetrahydrocannabinol (THC) and cannabidiol (CBD) for research.

“The number of available cannabis products and people using these products is increasing every day,” said Ziva Cooper, Ph.D., director of the Center for Cannabis and Cannabinoids at the University of California, Los Angeles. “This bill is … a national acknowledgement that we need more research on the benefits and harms of cannabis.”

One of the key provisions of the Medical Marijuana and Cannabidiol Research Expansion Act is to expedite the approval of Drug Enforcement Administration (DEA) licenses to companies to supply marijuana and other cannabis products for the purposes of medical research.

For over 50 years, the University of Mississippi—under a contract with the National Institute on Drug Abuse (NIDA)—had been the sole supplier of cannabis to U.S. scientists studying the drug. While this helped to maintain the consistency and comparability of the cannabis used in clinical studies, some experts argued that the product was of poor quality and not reflective of the cannabis available in dispensaries across the country. (See Numerous Hurdles Hinder High-Quality Cannabis Research.) Additionally, the demand for cannabis by researchers far outpaced the supply of approved research-grade cannabis.

Back in 2016, the DEA first announced plans to increase the number of approved cannabis cultivators. These rules were finalized in December 2020. As outlined in the Federal Register in December 2020, all entities authorized by the DEA to grow marijuana will receive a yearly quota set by the DEA on how much of the cannabis plant they can harvest. While individual companies get to decide what products they create out of this harvest (for instance, dried plants and/or extracts), the DEA has exclusive rights to purchase these products and distribute them to NIDA or other approved institutions.

Dozens of companies have applied for DEA licenses to become bulk cannabis growers since the rule was finalized in 2020; at the time Psychiatric News went to press, seven companies had been approved.

To accelerate the process for licensing companies to grow cannabis for research purposes, the Medical Marijuana and Cannabidiol Research Expansion Act requires the DEA to approve, deny, or request supplemental information from companies that submit applications within 60 days of the receipt of application. If more information is requested, the DEA is required to issue a final approval or denial within 30 days of receiving the supplemental information. Similar 60- and 30-day timeframes were set for the DEA to respond to researchers who submit applications for licenses to conduct studies with cannabis products.

While the legislation will lead to a greater supply of cannabis for researchers to study, Cooper and others who study cannabis cautioned that barriers to research remain.

“Getting access to a larger diversity of products and sources is important,” said Igor Grant, M.D., distinguished professor of psychiatry at the University of California, San Diego (UCSD) School of Medicine and director of the UCSD Center for Medicinal Cannabis Research. Still, there are questions as to how similar the cannabis produced by manufacturers will be to the products that Americans are accessing in dispensaries across the country, he continued. “A real forward movement would be to allow researchers to work with [products from] the dispensaries in their respective states.”

Grant acknowledged that acquiring cannabis direct from dispensaries may not be possible so long as cannabis remains a Schedule I controlled substance. We are headed down the right path,” Grant told Psychiatric News, but the United States needs a “national cannabis agenda.”

There have been some steps to standardize cannabis research, Grant noted. In May 2021, the National Institutes of Health established 5 mg of delta-9-tetrahydrocannabinol (THC) as a standard unit of measurement for research purposes (just as 0.6 oz of pure alcohol is considered one standard drink unit). This change will enable comparative analyses of studies that use different products.

The research landscape remains fragmented, with both federal and state agencies involved in overseeing cannabis research, Grant noted. This can make the process of obtaining licenses and (limited) funding tedious for researchers.

The Medical Marijuana and Cannabidiol Research Expansion Act aims to ease some of the administrative burden on researchers studying cannabis. For instance, researchers who have a DEA license can now amend their study protocols without requiring the DEA to re-review their application, so long as the researchers don’t change the quantity, type, or source of their cannabis.

As Cooper explained to Psychiatric News, however, these stipulations primarily benefit researchers and universities who have already done the legwork to establish cannabis research programs.

She noted that the process of applying for a DEA license can be a big barrier for many investigators and institutions.” Researchers looking to initiate cannabis research (or work with other controlled substances like psychedelics) then need to secure administrative support and ensure they have the requisite storage and security measures for handling a controlled substance. ■