The U.S. Food and Drug Administration is expected to decide by the end of the month whether to approve GW Pharmaceuticals’ Epidiolex. It’s a purified form of cannabidiol — a component of cannabis that doesn’t get users high — to treat Dravet and Lennox-Gastaut syndromes in kids.
Cannabidiol’s effect on a variety of health conditions is frequently touted, but there is still little evidence to back up advocates’ personal experiences. The U.S. Drug Enforcement Administration has long categorized cannabis as a Schedule I drug, a category with “no currently accepted medical use and a high potential for abuse.” That strictly limits research on potential medical uses for cannabis or the chemicals in it, including cannabidiol, or CBD.
Advocates became particularly concerned when GW Pharmaceuticals’ U.S. commercial business, Greenwich Biosciences, began quietly lobbying to change states’ legal definition of marijuana, beginning in 2017 with proposals in Nebraska and South Dakota.
Some worried the company’s attempt to ensure its product could be legally prescribed and sold by pharmacies would have a side effect: curtailing medical marijuana programs already operating in more than two dozen states.
The proposals generally sought to remove CBD from states’ legal definition of marijuana, allowing it to be prescribed by doctors and supplied by pharmacies. But the change only applies to products that have FDA approval.
Neither Nebraska nor South Dakota allows medical use of marijuana, and activists accused the company of trying to shut down future access to products containing cannabidiol but lacking FDA approval.
GW Pharmaceuticals never intended for the changes to affect other marijuana products, but they are necessary to allow Epidiolex to be sold in pharmacies if approved, spokesman Stephen Schultz said.
He would not discuss other places where the company will seek changes to state law. The Associated Press confirmed that lobbyists representing Greenwich Biosciences backed legislation in California and Colorado this year.
“As a company, we understand there’s a significant business building up,” Schultz said. “All we want to do is make sure our product is accessible.”
Legal experts say the changes are logical. Some states’ laws specifically prohibit any product derived from the marijuana plant from being sold in pharmacies. The FDA has approved synthetic versions of another cannabis ingredient for medical purposes but has never approved marijuana or hemp for any medical use.
A panel of FDA advisers in April unanimously recommended the agency approve Epidiolex for the treatment of severe seizures in children with epilepsy, conditions that are otherwise difficult to treat. It’s not clear why CBD reduces seizures in some patients, but the panel based its recommendation on three studies showing significant reduction in children with two forms of epilepsy.
Denver-based attorney Christian Sederberg, who worked on the GW Pharmaceuticals-backed legislation in Colorado on behalf of the marijuana industry, said all forms of marijuana can exist together.
“The future of the industry is showing itself here,” Sederberg said. “There’s going to be the pharmaceutical lane, the nutraceutical (food-as-medicine) lane, the adult-use lane. This shows how that’s all coming together.”
Source – US News
Image – GW Pharmaceutical