On Jan. 15, the Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to discuss cannabis policy. The focal point of most of the hearing was about research into marijuana, its extracts and derivatives. Members of Congress repeatedly focused on why the research is limited, and the slowness of the process from research to implementation. The hearing covered the following six pieces of legislation.
H.R. 171, the Legitimate Use of Medicinal Marijuana Act (LUMMA)
H.R. 171, introduced by U.S. Rep. Morgan Griffith (R-Va.), transfers marijuana from Schedule I to Schedule II of the Controlled Substance Act (CSA). It also specifies that no provision of the CSA or the Federal Food, Drug and Cosmetic Act (FFDCA) shall prohibit or restrict activities related to medical marijuana that comply with a state's medical marijuana law. The bill does not affect any federal, state, or local law that regulates or prohibits smoking in public.
H.R. 601, the Medical Cannabis Research Act of 2019
H.R. 601, introduced by U.S. Rep. Matt Gaetz (R-Fla.), requires the attorney general to assess the supply of research-grade cannabis and directs the AG to increase the number of federally registered cannabis manufacturers for research purposes. The bill also allows Department of Veterans Affairs health providers to provide information to veterans about federally approved cannabis clinical trials, and to participate in such trials if registered under the CSA.
H.R. 1151, the Veterans Medical Marijuana Safe Harbor Act
H.R. 1151 was introduced by U.S. Rep. Barbara Lee (D-Calif.). The bill amends the CSA to include a safe harbor provision for veterans to use, possess or transport medical marijuana. The bill would allow physicians to discuss medical marijuana treatment with veterans and recommend that a veteran participate in medical marijuana treatment programs approved by state or tribal laws. The bill also directs the secretary of the Department of Veterans Affairs to conduct a study on the effects of medical marijuana on veterans in pain.
H.R. 2843, the Marijuana Freedom and Opportunity Act
H.R. 2843, introduced by U.S. Rep. Hakeem Jeffries (D-N.Y.), decriminalizes marijuana by removing marijuana and tetrahydrocannabinol (THC) from the list of Schedule I substances. The bill includes directives to conduct research on the impact of marijuana on the brain, the efficacy of medicinal marijuana, identification of additional medical benefits and uses of cannabis, and supports highway safety research. The bill requires the Alcohol and Tobacco Tax and Trade Bureau to promulgate regulations that require restrictions on advertising and promotion of marijuana products. The bill also includes a grant program for states and local governments for marijuana conviction expungement programs.
H.R. 3797, the Medical Marijuana Research Act of 2019
H.R. 3797, introduced by U.S. Rep. Earl Blumenauer (D-Ore.), would direct the secretary of the Department of Health and Human Services (HHS) to ensure a supply of marijuana for research purposes through the National Institute on Drug Abuse (NIDA) Drug Supply Program. Among other provisions, the bill directs NIDA and HHS to act on marijuana research registration applications within 30 days prior to supplying marijuana through the NIDA Drug Supply Program. The bill directs the Food and Drug Administration (FDA) to issue guidelines on the production of marijuana and to encourage authorized researchers and manufacturers to produce marijuana, in coordination with the law. The bill gives researchers who are approved for Schedules II through V the authorization to conduct research on marijuana. The bill also streamlines the protocol for researchers to receive an application approval from the attorney general. The bill prevents HHS from reinstating additional review processes related to marijuana research.
H.R. 3884, the Marijuana Opportunity Reinvestment and Expungement Act of 2019 (MORE Act of 2019)
H.R. 3884, introduced by U.S. Rep. Jerry Nadler (D-N.Y.), would remove marijuana and THC from the list of Schedule I drugs. The bill directs the attorney general to finalize rulemaking to remove marijuana and THC from the schedules of controlled substances. The bill directs the Bureau of Labor Statistics to compile public data on the demographics of the cannabis industry.
The bill also creates an Opportunity Trust Fund at the Treasury to support new programs, including the establishment of a Cannabis Justice Office within the Department of Justice Office of Justice Programs; and a Community Reinvestment Program that offers job training, re-entry services, and legal aid for civil and criminal cases, including expungement of cannabis convictions, literacy and health education programs, and youth recreation or mentoring programs. The bill includes authorities for the Small Business Administration to support services for cannabis-related businesses. The bill further includes a provision related to the expungement of arrests, convictions or adjudication related to federal cannabis offenses.
II. Summary of Witness Statements
Matthew J. Strait Senior Policy Advisor, Diversion Control Division Drug Enforcement Administration (DEA)
Strait emphasized that much like HHS, the Department of Justice (DOJ) and the DEA fully support research into the effects of marijuana and the potential medical utility of its chemical constituents. Strait stressed that there is a wait on getting the right science and approval out of the FDA to foster interagency collaboration on this topic. He added that over the past five years, there has been a 155 percent increase in the number of active researchers registered with DEA to conduct research with marijuana, its extracts and derivatives.
When asked about the status of rulemaking to remove marijuana from Schedule I to make it easier to conduct research, Strait answered that there is a draft regulation as of August 2019 that has been sent to the Office of Management and Budget (OMB). He also said that a call is scheduled for Jan. 16 within the Trump Administration to discuss a possible “schedule” change. He noted that more research was needed for future rulemaking. He stressed that the DEA is dependent on the science as performed or interpreted by the NIH and the FDA.
Douglas Throckmorton, M.D. Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research FDA
Throckmorton explained the FDA role in supporting the medical research community is to provide information on the process needed to conduct clinical research using cannabis, and on the specific requirements needed to develop a human drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its “Guidance for Industry: Botanical Drug Development,” which provides sponsors with guidance on submitting investigational new drug (IND) applications for botanical drug products. The FDA also offers support for investigators interested in research through meetings and regular interactions.
To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. However, it has approved one cannabis-derived drug product, Epidiolex (cannabidiol), and three synthetic cannabis-related drug products, Marinol (dronabinol), Syndros (dronabinol) and Cesamet (nabilone). These approved drug products are only available with a prescription from a licensed healthcare provider. Importantly, the FDA has not approved any other cannabis, cannabis-derived, or CBD products currently available on the market. Throckmorton emphasized the need for research and protocol to let the FDA move forward with any regulations, having noted the adverse effects of cannabis and CBD.
Nora D. Volkow, M.D. Director, National Institute on Drug Abuse National Institutes of Health (NIH)
Volkow was another proponent of expanding research into cannabis before any regulatory or statutory decisions are made. She told subcommittee members that cannabis is not a benign substance, and cannabis exposure carries particular risk early in life, as well as association to addiction and possible mental illnesses. However, she clarified that research is meant to determine the adverse effects of cannabis and its compounds, while isolating the beneficial medical effects.
Cannabis has been legalized for medical use in many states. Some synthetic forms of THC are FDA approved (i.e., Marinol and Syndros) for the treatment of anorexia and weight loss in AIDS patients and for nausea and vomiting associated with cancer treatment. The FDA also approved Cesamet, which contains the active ingredient nabilone, a synthetic chemical similar to THC, for treating nausea and vomiting related to cancer chemotherapy.
Expanded Research: Currently, cannabis research must use cannabis products sourced through the National Institute on Drug Abuse NIDA’s Drug Supply Program single DEA licensee: the University of Mississippi. This requirement prevents researchers from studying cannabis products used in commercial development and purchasing strains of cannabis from other sources, such as from widely used state dispensaries. The entire witness panel and a bipartisan number of subcommittee members agreed that more research is needed — and that could include allowing more licensees to gain the right to supply the cannabis product for research. Ranking Member Greg Walden (R-Ore.) emphasized that without data, there are arbitrary limits per package of cannabis products in states.
Schedule I Drug: Because cannabis is a Schedule I drug, it requires DEA approval for derivatives to be researched. At present, more research is conducted on marijuana, marijuana extracts and marijuana derivatives than any other Schedule I substance in the U.S. Members spent a majority of the hearing agreeing that to expand the research needed for more clarity on cannabis, the DEA will have to approve more licensees of the products. Strait, from the DEA, emphasized that the process remains tethered to the science.
Law Enforcement: Again, witnesses testified that only research can help determine more specific levels of THC that state and federal laws can take into account as “under the influence of” to enforce and regulate possible future use.
Beyond Research: The FDA’s Throckmorton noted that while there are always requirements on approving products, there is also protocol to understand labeling and dosage. The thrust of his responses was that getting a product to market with FDA approval is more complicated with cannabis than other drugs because the FDA needs to determine a roadmap that takes into account the variety of potential products. He added that these processes take time, if they were to be in motion. He agreed that more investigational studies are needed.
Interagency Collaboration: When witnesses were asked what tools they needed to move forward, they agreed that interagency collaboration was needed and should continue.
Slowed Process: Members were concerned by how slow the process of cannabis research for medicinal purposes was going, while 11 states have already approved cannabis for recreational use.
IV. Conclusion/Next Steps
The discussed legislation will have to undergo a markup and vote by the Health Subcommittee, with the possibility of added amendments to each bill. If favorably forwarded to the full Committee on Energy and Commerce, another markup and vote will be held. The legislation could be further amended by the full committee, and if passed, will then be sent to the House floor for consideration.