In October, when pardoning those federally convicted of cannabis possession, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022. The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. The legislation passed in the House by a 325 to 95 vote last July and by Voice Vote in the Senate in mid-November. President Biden signed the law on December 2nd.
As Congressman Earl Blumenauer (D-Oregon), founder and co-chair of the Congressional Cannabis Caucus and a sponsor of the bill observed, “Research is foundational for the path forward on cannabis policy. Research is essential to better understand the therapeutic benefits of cannabis that have the potential to help millions of Americans struggling with chronic pain, PTSD, multiple sclerosis, anxiety disorders and more.” Earl Blumenauer, Press Release, Dec. 2, 2022.
We discuss the statute’s major provisions summarized below.
A. Federal Research
As discussed in more detail below, the Act facilitates research of cannabis and its derivatives including cannabidiol (“CBD”), extracts, preparations and compounds, and the development of approved medications. However, its most significant and enduring impact on federal cannabis regulation may be the mandate that HHS assess the compound’s therapeutic potential. Within a year, HHS in coordination with the National Institutes of Health (“NIH”) must report to the Caucus on International Narcotics Control and responsible congressional committees on:
- The potential therapeutic effects of cannabis on serious medical conditions including intractable epilepsy; and
- The potential effects of cannabis, including the increase of delta-9-tetrahydrocannabinol (“THC”) levels on the human body, adolescent brains and the cognitive abilities to operate motor vehicles or heavy equipment.
The report must also discuss the barriers associated with conducting research with cannabis and CBD in states that have legalized their use, how barriers might be overcome and whether public-private partnerships or federal-state partnerships can or should provide researchers with additional cannabis and CBD strains. HHS, in addition, must, “[t]o the extent practicable, the Secretary of Health and Human Services, either directly or through awarding grants, contacts [sic] , or cooperative agreements, shall expand and coordinate the activities of the NIH and other relevant federal agencies to better determine the effects of cannabis outlined in the report.”
To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. The Act requires that HHS provide a scientific analysis on whether cannabis and its derivatives are safe and effective treatments for different medical ailments and their other effects on the human body. A positive finding in this regard is critical to any potential that cannabis would be approved for medical use under federal law.
B. Doctor-Patient Relationship
Also of great importance is the Act’s authorizing state-licensed physicians to advise patients or their legal guardians of the potential harms and benefits of cannabis derivatives as a medical treatment. As a federally-controlled schedule I substance, cannabis by definition has no currently accepted medical use in treatment in the U.S. 21 U.S.C. § 812(b)(1)(B). The Act is silent as to whether those physicians must hold a Drug Enforcement Administration (“DEA”) registration but significantly does not authorize physicians to administer, dispense nor prescribe cannabis. There is no explicit federal prohibition against DEA-registered physicians advising patients on cannabis as a medical treatment, but to do so could subject a physician to DEA scrutiny.
C. Adequate and Uninterrupted Supply of Cannabis
The Act places the onus on DEA to ensure an adequate, uninterrupted supply of cannabis for research. The Act requires DEA, in consultation with HHS, to assess annually whether an adequate and uninterrupted supply, down to specific strains, exists and to establish sufficient quotas to ensure an uninterrupted supply. Should DEA and HHS determine cannabis, even specific strains, to be inadequate or interrupted, DEA must report to Congress within 60 days on:
- The contributing factors;
- Expected impacts on approved ongoing research protocols; and
- Specific steps the agency will take to restore an adequate, uninterrupted supply.
It is unclear whether DEA, FDA or both will make the determination whether a shortage exists.
D. Cannabis Researcher Registrations
1. Application Process
The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. DEA must register practitioners to conduct cannabis research if (i) their protocol has been approved by HHS or NIH, and (ii) they have effective procedures to safeguard the compound in the quantities they seek to use in research against diversion. DEA may deny an application if it determines the registration would be inconsistent with the public interest by considering:
- Recommendations of the appropriate state licensing board or professional disciplinary authority;
- The applicant’s experience in dispensing or conducting research with 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. 21 U.S.C. § 823(g)(1).
With respect to timing, DEA must issue a registration or request supplemental information within 60 days after receiving a complete application. DEA then has 30 days after receiving supplemental information to issue or deny a registration. DEA must provide a written explanation of the basis for denying a registration. The Act authorizes DEA to deny registrations only if approved protocols lack adequate security.
2. Research Protocols
As a reminder, the Controlled Substances Act (“CSA”) and DEA regulations require that research with cannabis and other schedule I drugs can only be conducted with a protocol approved by DEA and FDA. 21 C.F.R. §§ 1301.13(e), 1301.18, 1301.32. The Act allows researchers to amend or supplement their research protocol without notifying DEA if there is no change to cannabis quantity or type, its source, or to its storage, tracking or administration. If a researcher wishes to change those research elements, they must notify DEA via registered mail or electronically within 30 days before implementation. Researchers may proceed if DEA does not explicitly object within 30 days, and the agency can only object if additional security is required.
If a change of cannabis quantity does not impact other factors, researchers must notify DEA by registered mail or electronically and the agency must respond within 3 days. Notifications are deemed approved unless DEA explicitly objects within 10 days if it finds that a change in quantity impacts the cannabis source or how it is stored, tracked, administered or requires additional security measures.
Although the Act limits DEA’s authority over cannabis research protocols, it does not limit HHS’ authority, including over changes in the method of administration, dosing and the number of individuals involved in research
DEA must promulgate regulations implementing these application process changes within one year.
Researchers must store cannabis in a securely locked, substantially constructed cabinet. 21 C.F.R. § 1301.75(a). The Act restricts DEA from mandating more stringent security requirements for cannabis researchers than those imposed on other schedule I and II researchers.
E. Cannabis Manufacturer Registration for Research
As with cannabis researcher registrations, the Act requires DEA to approve an application for a cannabis manufacturer registration or request supplemental information within 60 days after receiving complete applications. Manufacturer applications are complete when the applicant has demonstrated that they:
- Have satisfied requirements designated in the Federal Register notice;
- Have satisfied statutory and regulatory requirements;
- Will transfer or sell cannabis only to DEA-registered researchers for preclinical research or clinical investigation pursuant to a New Drug Exemption;
- Will transfer or sell cannabis only with prior, written DEA consent;
- Has completed the application and review process for bulk manufacture of schedule I
- Has established and begun a process for storing and handling schedule I substances including inventory control and security; and
- Is licensed by each state in which it will conduct operations.
Also like researcher applications, DEA must approve or deny issuing a registration within 30 days after receiving requested supplemental information and must provide written explanation of the basis of a denial.
F. Commercial Production and Distribution of FDA-Approved Cannabis Drugs
Consistent with the Controlled Substances Act, DEA cannot deny a manufacturer registration solely on the basis that the applicants wants to manufacture an FDA-approved product containing cannabis.
Other cannabis-related bills that were not acted upon in the waning days of the 117th Congress include the Secure and Fair Enforcement Banking Act of 2021 (“SAFE Banking Act”), Veterans Equal Access Act, the Preparing Regulators Effectively for a Post-Prohibition Adult-Use Regulated Environment Act of 2022 (“PREPARE Act”) and the Veterans Medical Marijuana Safe Harbor Act.