The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act is the first stand-alone marijuana legislation passed in decades and, according to some news sources, President Biden will likely sign it within the next two weeks. Historically, conducting research with Schedule I controlled substances has been subject to numerous administrative hurdles and onerous security requirements that have deterred many potential researchers. The Act amends key sections of the Controlled Substances Act (CSA) to ease some of those restrictions and to facilitate research on marijuana and its potential therapeutic benefits, without changing marijuana’s designation as a Schedule I controlled substance. Some of the key provisions are summarized below.
Production and Supply
Until 2021, the University of Mississippi was the only entity approved by the Drug Enforcement Agency (DEA) to supply DEA- and U.S. Food and Drug Administration (FDA)-registered research facilities with marijuana. Many argued that this marijuana was not representative of the products available to consumers in the growing marijuana marketplace. In December 2020, the DEA finalized a rule to facilitate the registration of additional bulk marijuana manufacturers, and, as of August 2022, six additional manufacturers have been registered.
The Act now requires the Secretary of Health and Human Services (the Secretary) to coordinate with the U.S. Attorney General to annually consider if there is an inadequate and interrupted supply of marijuana, including specific strains for research purposes. If so, the Attorney General and Secretary must report to Congress within 60 days of the determination and the report must include, at a minimum:
- (1) the factors contributing to the inadequate or interrupted supply of marijuana;
- (2) expected impacts of the inadequate or interrupted supply on ongoing research protocols; and
- (3) specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.
Previously, the Attorney General had discretion to deny any entity seeking DEA registration to conduct research with Schedule I controlled substances. See 21 U.S.C. § 823(f). Under the Act, the Attorney General must register an applicant to conduct research with marijuana (including any derivative, extract, preparation, and compound) if:
- the applicant’s research protocol has been reviewed and has allowed the use of marijuana:
- by the Secretary as a drug used for investigational use and clinical research under FDA regulations; or
- by the National Institutes of Health or another federal agency that funds scientific research; or
- pursuant to DEA regulations related to research protocols for Schedule 1 substances, see 21 C.F.R. §§ 18, 1301.32; and
- the applicant has demonstrated to the Attorney General that there are effective procedures in place to adequately safeguard against diversion of the marijuana, including demonstrating that the security measures are adequate for storing the quantity of marijuana the applicant would be authorized to possess.
Furthermore, the Attorney General may deny an application, should it be inconsistent with the public interest. The Attorney General must consider the following factors when determining the public interest:
- The applicant’s experience in dispensing, or conducting research with respect to controlled substances;
- The applicant’s conviction record under federal or state laws, relating to the manufacture, distribution, or dispensing of controlled substances;
- Compliance with applicable state, federal, or local laws relating to controlled substances; and
- Such other conduct, which may threaten the public health and safety.
The Attorney General will have 60 days to approve a complete application for registration or to request supplemental information. If the Attorney General requests supplemental information, the application must be approved or denied within 30 days of receiving it. The Act also amends the CSA to include these deadlines for any application to manufacture marijuana for research purposes.
Consideration of Research Results
Although the Act does not reschedule marijuana, it requires the Secretary, to coordinate with the Director of the National Institutes of Health and the heads of other relevant federal agencies, to submit a report, within a year after the date of enactment, to the Caucus on International Narcotics Control, the Committee on the Judiciary, and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce, and the Committee on the Judiciary of the House of Representatives, on:
- (1) the potential therapeutic effects of cannabidiol or marijuana on serious medical conditions, including intractable epilepsy;
- (2) the potential effects of marijuana, including —
- (A) the effect of increasing delta-9-tetrahydrocannabinol levels on the human body and developing adolescent brains; and
- (B) the effect of various delta-9-tetrahydrocannabinol levels on cognitive abilities, such as those that are required to operate motor vehicles or other heavy equipment; and
- (3) the barriers associated with researching marijuana or cannabidiol in states that have legalized the use of such substances, including —
- (A) recommendations on overcoming such barriers, including whether public-private partnerships or federal-state research partnerships may, or should be, implemented to provide researchers with access to additional strains of marijuana and cannabidiol; and
- (B) recommendations as to what safeguards must be in place to verify that —
- (i) the levels of tetrahydrocannabinol, cannabidiol, or other cannabinoids contained in products obtained from such states is accurate; and
- (ii) such products do not contain harmful or toxic components.
Critics have pointed out, during earlier versions of the bill, that many of the deadlines imposed by the Act on the federal agencies tasked with implementing it may not be enforceable because Congress did not include consequences for failing to comply with those deadlines. Assuming President Biden signs the Act, only time will tell whether these agencies will test the boundaries of that critique by ignoring deadlines.
In any event, the Act is a key step on the path to federal marijuana legalization, since the research system it puts in place, should, at least in theory, make more diverse types of marijuana products available for research and produce data critical to understanding the therapeutic potential of drugs containing or derived from marijuana. Other bills have also been proposed to encourage research into CSA Schedule I drugs such as psychedelics, marijuana, and other controlled substances. Congressional activity in this space provides further evidence of the slow, but steady progress toward legalization and federal regulation.