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The United States Food and Drug Administration (FDA) supports a regulated, well-researched avenue for the development of drugs derived from cannabis, a senior FDA official told US lawmakers late last month.
The agency is in favor of “scientific research into the medical uses of cannabis and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process,” said deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, Douglas Throckmorton, M.D.
Speaking before the House Committee on Energy and Commerce Subcommittee on Health, Throckmorton said the FDA supports medical researchers who intend to study cannabis by providing them with information on the clinical cannabis research process and its requirements, and by assisting them throughout the investigational new drug (IND) process.
Throckmorton said the FDA will also help investigators “understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance Group.
The IND application is an essential step when performing clinical research for the development of new drugs. Throckmorton As of now, the FDA has approved one cannabis-based medication, a Epidiolex (CBD), which is used in treatment for rare forms of epilepsy.
“The Agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process,” Throckmorton added.
Throckmorton also addressed the growing market of consumer CBD products, saying that “storefronts and online retailers have flooded the market with these products, many with unsubstantiated therapeutic claims.”
He added that there are “many unanswered questions” about the safety and science behind many CBD products and that those that make serious health claims “may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.”
The statement then lists what Throckmorton said are the potential risks associated with using CBD products, including liver injury, male reproductive toxicity, and problematic interactions with other medicines the consumer is taking.
He added that the FDA is also working to learn more about the safety of CBD and CBD products and is weighing new legal pathways for CBD products.
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