Conducting clinical research using marijuana involves interactions with several federal agencies. This includes: a registration administered by the Drug Enforcement Administration (DEA); obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA), within the National Institutes of Health, or another DEA-registered source; and review by the FDA of an investigational new drug (IND) application and research protocol. Additionally:
As a Schedule I controlled substance under the Controlled Substances Act, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site marijuana will be studied.
NIDA provides research-grade marijuana for scientific study. The agency is responsible for overseeing the cultivation of marijuana for medical research and has contracted with the University of Mississippi to grow marijuana for research at a secure facility. Marijuana of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute marijuana for research purposes.
Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs, in the Center for Drug Evaluation and Research (CDER), depending on the therapeutic indication.
The roles of the three agencies are the same for investigations of marijuana for use as an animal drug product, except that researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.
