Marijuana Research with Human Subjects
Conducting clinical research using marijuana involves interactions with several federal agencies. This includes: obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health or another Drug Enforcement Administration (DEA)-registered source; review of an investigational new drug (IND) application and the research protocol by the Food and Drug Administration (FDA) and an investigator registration and site licensure by the DEA. Specifically:
- National Institute on Drug Abuse (NIDA) to obtain the marijuana for research. One important source of research-grade marijuana for scientific study is through the NIDA drug supply program. The marijuana supply program operates pursuant to the Single Convention on Narcotic Drugs, which imposes certain obligations related to governmental oversight of marijuana cultivation. In the United States, NIDA has long acted as the agency responsible for overseeing the cultivation of marijuana for medicinal research. Operating under DEA registrations for growing and processing marijuana for medicinal research, NIDA contracts with the University of Mississippi to grow marijuana for use in research studies. The University designates a secure plot of land where marijuana crops are grown, harvested, and stored. The marijuana is made into cigarettes or other purified elements of marijuana to use for research. Investigational marijuana products with varying strengths or potencies are available. DEA also may allow additional growers to register with the DEA to produce and distribute marijuana for research purposes.
- Food and Drug Administration (FDA) to submit an investigational new drug (IND) application. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as marijuana, researchers need to work with the FDA and submit an IND application. The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. Specifically, the Guidance for Industry: Botanical Drug Development provides sponsors with guidance on submitting investigational INDs for botanical drug products.
- Drug Enforcement Administration (DEA) to obtain investigator registration and site licensure to conduct studies using marijuana. As a Schedule I controlled substance under the Controlled Substances Act (CSA), marijuana use in a clinical trial requires special licensure and registration requirements for the investigator and the site where the study will be conducted. For more information, see 21 CFR 1301.18.
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
Step 2: Sponsor contacts NIDA or another DEA-registered source of marijuana to obtain information on the specific strains of marijuana available, so that all necessary chemistry, manufacturing, and controls (CMC) information can be included in the IND application.
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
Step 4: If applicable, Sponsor obtains from NIDA as Letter of Authorization (LOA) to reference CMC information in NIDA’s Drug Master File (DMF) on file with FDA.
Step 5: Sponsor sends copy of IND/protocol, including a LOA to reference CMC information in a Drug Master File (if applicable), to FDA and DEA.
Step 6: FDA reviews the IND.
Step 7: Sponsor contacts NIDA or another DEA-registered source to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.
- Development & Approval Process (Drugs)
- FDA Center for Drug Evaluation and Research Small Business and Industry Assistance group
- National Institutes of Health (NIH): Guidance on Procedures for Provision of Marijuana for Medical Research
- National Institute on Drug Abuse's (NIDA) Role in Providing Marijuana for Research
- Drug Enforcement Administraton - Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
- International Narcotics Control Board: Single Convention on Narcotic Drugs (1961)
- National Institute on Drug Abuse (NIDA): Ordering Guidelines for Marijuana and Marijuana Cigarettes