If You Want It Done . . . Bill to Facilitate Marijuana and CBD Research Re-Introduced in the SenateMarch 16, 2021
The Senate recently reintroduced legislation that would promote research into medical use of marijuana. The legislation would also importantly correct a deficiency in prior law and the Drug Enforcement Administration’s (“DEA’s”) recent rulemaking related to synthetically derived CBD.
Marijuana remains classified as a schedule I controlled substance under the federal Controlled Substances Act. Because drugs in schedule I are defined to have “no currently accepted medical use in treatment in the United States,” distribution except in very limited circumstances of any product containing marijuana remains illegal at the federal level. 21 U.S.C. § 812(b)(1)(B). To date, only certain drugs containing THC such as Marinol, and hemp-derived CBD with less than 0.3 percent delta-9-tetrahydrocannabinol (“THC”) have been excluded form Schedule I. Yet despite federal law, 36 states and the District of Columbia have authorized the manufacture, distribution and use of marijuana and/or its constituents including THC and cannabidiol (“CBD”) for a wide-range of differing medical indications.
We reported in January how after more than four years DEA finally issued its final rule on registering additional manufacturers of marijuana for research. (For our post, see The Long and Winding Road: DEA Issues Final Marijuana Registration Rule, Jan. 8, 2021.) Congress, however, has not been sitting idly with respect to cannabis research. Senators Dianne Feinstein (D-CA), Chuck Grassley (R-IA) and Brian Schatz (D-HI) re-introduced a bill with bipartisan support in the Senate that seeks to expand medical research with marijuana and CBD by removing some of the restrictive regulatory roadblocks. The Senate unanimously passed an identical bill during the waning days of the last Congress. Senator Feinstein, re-introducing the Cannabidiol and Marihuana [sic] Research Expansion Act on February 4th observed, “If the science shows that marijuana and its derivatives, including CBD can effectively treat serious medical illnesses, we should enable products containing these substances to be brought to the market with FDA approval. But in order to make this determination, we must reduce the barriers currently impede important research.” Feinstein, Grassley, Schatz Introduce Bill to Expand Cannabidiol, Marijuana Research, Press Release, Feb. 5, 2021.
The bill, S. 253, would promote cannabis research by requiring the Attorney General (by delegation, DEA) to register researchers if Health and Human Services (“HHS”), National Institutes of Health (“NIH”), or another federal agency that funds scientific research reviews and approves their research protocol and they employ adequate security measures to prevent diversion. DEA would have to approve registration applications or request supplemental information within 60 days, then approve or deny registrations within 30 days after receiving supplemental information.
The bill would also expedite the process to increase the quantity of cannabis for research and facilitate protocol changes without requiring researchers to reapply. Researchers seeking to increase drug quantities would only have to notify DEA instead of both DEA and FDA. Researchers seeking to amend approved protocols involving changes to drug quantity or type, its source or storage, tracking or administration conditions must only notify DEA at least 30 days before implementation. Their request would be deemed approved unless DEA objects within 30 days. The agency can only object if additional security safeguards are required. HHS would maintain authority over research protocols, including changes in administration, dosing and number of patients. The bill requires DEA to issue regulations related to these changes within a year.
In addition to requiring DEA to process cannabis researcher applications within a certain timeframe, the bill imposes time constraints by when the agency must move on bulk marijuana manufacturer applications. For bulk marijuana manufacturers, DEA would have to approve or request supplemental information for applications to manufacture for research solicited in the Federal Register within 60 days of receiving an application, then approve or deny the application within 30 days of receiving required supplemental information. Requiring DEA to move on marijuana manufacturer applications is a welcome advancement of the registration process as some of the 38 marijuana manufacturer applications received by DEA lingered for four years after the agency announced that it would issue additional registrations in August 2016.
The bill streamlines development of FDA-approved drugs using marijuana and CBD by:
- Allowing accredited universities and medical schools, practitioners and manufacturers with a schedule I registration to manufacture, distribute, dispense and possess marijuana for medical research aimed at drug development or commercial production;
- Requiring DEA to license manufacturers and distributors for the commercial production of FDA-approved marijuana or CBD drugs; and
- Allowing DEA-registered institutions to import or export marijuana or CBD to conduct medical research for drug development.
Within one year of enactment, HHS must report to Congress on potential therapeutic effects of marijuana and CBD on serious medical conditions, and their effects on the human body, the adolescent brain, and on cognitive abilities, including the ability to operate vehicles and heavy equipment. HHS will also report on the research barriers of marijuana grown in states that have legalized its use, and recommend how to overcome them.
The bill would allow physicians to discuss the potential harm and benefits of marijuana derivatives like CBD, as treatment with patients.
The bill also corrects a non-sensical interpretation stated in DEA ‘s August 21, 2020 interim final rule that non-plant, synthetic CBD is a schedule I substance regardless of whether its THC content on a dry weight basis is at or below the 0.3% level for non-controlled hemp-derived CBD. The bill would amend the definition of marijuana in the CSA to exclude the synthetic equivalent of hemp-derived CBD containing less than 0.3% THC. It makes no sense to treat synthetic CBD as a schedule I controlled substance when its abuse potential, little as it may be, is less than hemp-derived CBD. The bill would allow researchers and others to handle synthetic CBD without having to comply with DEA registration, recordkeeping and security requirements.
A number of organizations support the bill including the American Medical Association, American Academy of Pediatrics, American Society of Addiction Medicine, Friends of the National Institute on Drug Abuse, National Cannabis Industry Association and the National Organization for the Reform of Marijuana Laws.
The bill has been referred to the Committee on the Judiciary.