A key FDA official told members of Congress last month that the agency supports the development of new drugs that contain cannabis or are derived from the plant.
Speaking before the House Committee on Energy and Commerce, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said investigators interested in conducting cannabis research that could lead to a drug approval need to first submit an investigational new drug (IND) application.
Even though cannabis is among Schedule I substances considered to have a high potential for abuse and no accepted medical value, Throckmorton said these substances can be evaluated in clinical trials as long as sponsors submit an IND and register with the Drug Enforcement Administration.
An IND application includes descriptions of proposed studies, information about the investigators’ qualifications, and assurances that human participants in trials provide informed consent and that their rights, safety, and welfare are protected. The agency is also considering whether or how to establish legal pathways for the safe marketing of dietary supplements and/or foods containing cannabis’ nonpsychoactive component, cannabidiol.
Throckmorton noted that an FDA botanical review team is available to assist with the development of plant-based drugs. “It is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis,” he said.