On January 15, the Subcommittee on Health of the Committee on Energy and Commerce held its first ever legislative hearing to address federal cannabis policies. The subcommittee invited witness from three different agencies to provide testimony: Matthew K. Strait, Drug Enforcement Administration (“DEA”); Douglas Throckmorton, Food and Drug Administration(“FDA”); and Nora D. Volkow, National Institutes on Drug Abuse (“NIDA”). The hearing lasted over three hours and included several areas of discussion. Here are some highlights:
- DEA Has Completed New Draft Regulations
In August of last year, the DEA announced it was adjusting its policies and practices to include a transition from the current single-grower system to the addition of multiple registered growers. No updates on the rulemaking process had been provided until DEA witness Matthew Strait’s announcement at the subcommittee hearing. “We actually have a draft regulation in place,” Strait announced. “And tomorrow, some of us will be on a call to talk about it.” The draft is currently being reviewed by the White House Office of Management and Budget (“OMB”). These new regulations should, in theory, expand the quantity and variety of marijuana that it permits for use in scientific and medical research.
- Marijuana Research Is A “Catch-22”
All witnesses agreed that more medical research on cannabis is needed, and that the current amount and variety of marijuana available to researchers is inadequate to conduct meaningful research. For researchers to have access a wider range and larger volume of marijuana, the DEA either needs toincrease the number of registered growers or reschedule marijuana on the Controlled Substances Act (“CSA”). As mentioned above, the DEA is in the process of registering more growers, but it is not clear how many growers will be registered or when this will occur.
The other option, rescheduling, would allow researchers to access marijuana currently being grown across the country by state-licensed growers. Absent congressional action, rescheduling must done administratively and would require the FDA to issue a recommendation on marijuana’s medical efficacy and safety. However, therein lies the problem: the FDA “can’t conduct research until they show cannabis has a medical use, but they can’t demonstrate cannabis has a medical use until they can conduct research,” Subcommittee Chairwoman Anna Eshoo remarked: “This has created a Catch-22 by denying marijuana’s medicinal use because it is not FDA-approved, yet still restricting the research that would be required for FDA approval.” Despite this predicament, there was widespread agreement that more research is needed.
- FDA Has The Tools To Regulate CBD…But More Research Is Needed
FDA indicated last year that it may take three to five years to issue a final regulation clarifying a non-drug pathway for CBD. Members of Congress have been outspoken about their dissatisfaction with this timeframe, urging that lack of market clarity will have negative economic consequences. As we discussed here, Rep. Collin Peterson of Minnesota has introduced legislation that would essentially skirt the current FDA evaluation process and classify CBD as a dietary supplement via an exemption to the drug preclusion rule in the Food, Drug, and Cosmetic Act.
FDA witness Douglas Throckmorton stated that FDA has the tools it needs to evaluate CBD. However, to use those tools, he reiterated concerns that must be addressed such as potential liver toxicity, male reproductive system ramifications, and drug interactions. These evaluations take (spoiler alert) clinical data and the agency does not believe it has sufficient data yet, as voiced by FDA Deputy Commissioner Amy Abernethy recently.
At times, the exchanges between the committee members and the witnesses were tense, evidencing frustration that marijuana and CBD are widely sold but hurdles to research remain. While various subcommittee members queried around steps that could be taken to address the need for more research, it is unclear what, if anything, will result. It is unclear how much support the Peterson bill actually has and, although frustrated with the lack of an apparent non-drug pathway, some in industry are reluctant to support regulation via legislation.