Authorizing CBD to be sold in “consumer-focused products further diminishes incentives to continue research and development of new medicines,” GW Pharmaceuticals plc warned earlier this month in comments filed with FDA.
As FDA considers authorizing the use of CBD in consumer products—including conventional food and dietary supplements—GW’s comments underscored one of the agency’s chief challenges: preserving incentives for the pharmaceutical industry to invest in medicine proven effective and safe.
GW is the manufacturer of Epidiolex, an FDA-approved medicine to treat seizures associated with two rare forms of epilepsy in children: Dravet syndrome and Lennox-Gastaut syndrome. The company introduced Epidiolex in the United States on Nov. 1, 2018.
United Kingdom-based GW is in an unenviable position: competing for patients with scores of unapproved CBD products—including those sold online and at retail stores across the United States.
Consumers flock to non-prescription CBD products
Among the nearly 4,500 comments filed with FDA concerning its regulation of cannabis-derived products, many consumers reported using CBD to treat various medical conditions.
“CBD tincture has made a huge improvement to my health,” consumer Loretta Connatser wrote to FDA. “I am a combat veteran with chronic pain, chronic migraines, anxiety, depression and PTSD [post-traumatic stress disorder].”
Forty seven states and the District of Columbia have legalized cannabis for medical use, GW observed. Citing the public charity, ProCon.org, GW reported an estimated 3.5 million Americans use medical cannabis products that haven’t been approved by FDA.
“Millions of Americans are self-treating serious and life-threatening ailments with unproven, inadequately regulated, and unapproved cannabis and cannabis-derived products,” GW cautioned FDA in its written comments.
The biopharmaceutical company’s investments into the potential medical benefits of cannabis-derived products began in 1998, culminating 20 years later in approval of Epidiolex. Since 1998, GW has performed more than 50 placebo-controlled trials and more than 100 preclinical studies.
GW intends to file a new drug application (NDA) for Epidiolex to treat seizures associated with Tuberous Sclerosis Complex, according to its comments filed with FDA. GW also is studying CBD on other serious medical conditions, including autism, multiple sclerosis, neonatal hypoxic ischemic encephalopathy (NHIE), neuropathic pain, Rett syndrome and schizophrenia.
In establishing a regulatory framework for cannabis-derived products, FDA should clearly distinguish between foods/dietary supplements and FDA-approved medicines, the company stated.
FDA’s CBD reconsideration may impact drug development
Citing clinical investigations conducted by GW, FDA has determined CBD is excluded from being added to conventional food or marketed as a dietary supplement. But for the first time ever, FDA is considering creating an exception to a rule in the law that excludes ingredients first studied as drugs from being marketed in supplements.
In adopting an “exclusionary rule” in the Dietary Supplement Health and Education Act of 1994 (DSHEA), “Congress recognized two now-settled principles” that have not been disturbed since the law’s passage, GW wrote.
“First, prescription drug ingredients are not suitable for mass-market use without physician oversight,” the company stated. “Second, permitting an FDA-approved pharmaceutical ingredient (e.g., CBD) in dietary supplements will serve as a disincentive to the substantial investment required to gain FDA approval as a new drug. FDA-approved prescription drugs should not be left to compete with dietary supplements that are not subject to the same development burdens and requirements.”
If FDA waives the exclusionary rule, it should adopt policies to ensure continued and expanded medical research of cannabis and its derivative products, GW said.
“FDA should focus efforts on drug development programs that target serious conditions and populations with unmet medical needs, utilizing an ‘all hands on deck approach’ and exercising regulatory flexibility wherever possible and appropriate,” the company added.
Beyond Epidiolex, FDA has approved three other drugs containing ingredients found in or related to the cannabis plant, an FDA official, Amy Abernethy, M.D., Ph.D., noted in July 2019 testimony before the Senate Committee on Agriculture, Nutrition and Forestry. Those drugs include Marinol, Syndros and Cesamet, which contains a synthetically derived ingredient that has a chemical structure similar to THC, according to an FDA Q&A.
“FDA is committed to doing what we can to facilitate and preserve incentives for clinical research,” Abernethy, co-chair of an FDA CBD working group, said. “We are concerned that widespread availability of CBD in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.”