New Medical Marijuana Law Streamlines Path for Conducting Marijuana and Cannabis Research
by Quarles & Brady LLP
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research.
The Act also permits appropriately registered covered institutions of higher education, practitioners, or manufacturers to manufacture, distribute, dispense, or possess marijuana or cannabidiol if done for the purpose of medical research for drug development or subsequent commercial production. This provision is designed to help to dispel previously held concerns that institutions of higher education would be at risk for loss of funding under the Drug-Free Schools and Campuses Act for engaging in marijuana research.
Prior to the passage of the Act, entities looking to conduct marijuana research were required to undergo a multi-pronged regulatory authorization and registration process involving submission of Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) followed by an additional review and registration process by the DEA.
Streamlining the Research Process
The Marijuana Research Act eases the process for research registration by requiring the DEA to register an entity to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if the applicant's research protocol has been reviewed and allowed by:
- The FDA’s IND application process under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i));
- The National Institutes of Health or another Federal agency that funds scientific research; or
- The DEA protocols for Research involving Schedule I substances pursuant to sections 1301.18 and 1301.32 of title 21, Code of Federal Regulations, or any successors thereto.
The Marijuana Research Act further imposes a 60-day review deadline for the DEA to approve an application or request additional information. The DEA would then have an additional 30 days after receiving the additional information to either approve the application or to issue a denial with a written explanation. The Act also eliminates the need for researchers to notify or seek approval from the DEA for specified changes to protocol so long as the registrant does not change:
- The quantity or type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof);
- The source of such marijuana or cannabidiol; or
- The conditions under which such marijuana or cannabidiol is stored, tracked, or administered.
The Marijuana Research Act allows researchers to implement such changes 30 days after providing notice to the Attorney General, provided that the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice.
The Act also clarifies that marijuana, or its components, shall be stored in a securely locked, substantially constructed cabinet and that any other security measures required by the DEA to safeguard against diversion consistent with those required for practitioners conducting research on other controlled substances in Schedules I and II that have a similar risk of diversion and abuse.
Ensuring an Adequate and Uninterrupted Supply of Research-Grade Marijuana
The Marijuana Research Act also contains provisions requiring the DEA to consult with Department of Health and Human Services (HHS) to determine whether there is an inadequate or interrupted supply of marijuana, including of specific strains for research purposes and to report to Congress within 60 days of the determination on at least:
- The factors contributing to the inadequate or interrupted supply of marijuana;
- Expected impacts of the inadequate or interrupted supply on ongoing research protocols; and
- Specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.
The Act further instructs the DEA to file a notice in the Federal Register to increase the number of entities registered to manufacture marijuana to supply appropriately registered researchers in the United States, and requires the DEA to, not later than 60 days after the date on which the Attorney General receives a completed application, either (i) approve the application; or (ii) request supplemental information.
Additional Provisions
Finally, the Act includes various other provisions that:
- Prohibit HHS from reinstating the interdisciplinary review process for marijuana research;
- Clarify that it is not a violation of the Federal Controlled Substances Act (CSA) for licensed-physicians to discuss the potential harms and benefits of marijuana and its derivatives (including CBD) with patients; and
- Require HHS, in coordination with NIH and relevant federal agencies, to report on the therapeutic potential of marijuana for various conditions such as epilepsy, as well as the impact on adolescent brains and on the ability to operate a motor vehicle.
For questions about this or other updates regarding state and federal efforts to reform marijuana laws, please contact the following or your local Quarles attorney: