The DEA has officially decided that a notorious fentanyl manufacturer’s synthetic marijuana product is safer and more medically valuable than actual weed.
In an announcement posted Wednesday in the Federal Register, the DEA announced that the drug Syndros, a liquid form of synthetic THC, will be classified as a Schedule II controlled substance, meaning it can be legally prescribed by doctors. Meanwhile, regular marijuana will continue to be listed alongside heroin in the more restrictive Schedule I category, which is reserved for drugs that have “no currently accepted medical use” and “a high potential for abuse.”
The FDA has already approved Syndros and the DEA’s final scheduling announcement means Syndros has cleared the final regulatory bar on the way to market.
Syndros is made by Insys Therapeutics, an Arizona-based pharma company accused of using dubious marketing practices to sell Subsys, a spray form of the powerful synthetic opioid fentanyl approved by the FDA to treat cancer pain. Several former top Insys executives — including John Kapoor, the company’s billionaire founder — have been arrested and charged with bribing doctors and defrauding insurance companies. The company and its ex-leaders also face several lawsuits from states and individuals for allegedly triggering America’s opioid epidemic.
Kapoor, who remains the largest shareholder at Insys, has pleaded not guilty and denied all wrongdoing. He was freed on $1 million bail after his arrest on Oct. 26.
Earlier this year, new Insys president and CEO Saeed Motahari called the launch of Syndros “a pivotal milestone” for the company. The drug is similar to Marinol, another synthetic THC product previously approved by the FDA to treat anorexia from AIDS or cancer. THC occurs naturally in marijuana, and it’s the main psychoactive component that makes users feel high.
The DEA granted preliminary Schedule II status to Syndros in March and listed it alongside OxyContin, Percocet, cocaine, methamphetamine, and other drugs in the category for substances that have some medical value but “a high potential for abuse.”
Despite that 29 states and Washington, D.C., have now legalized some form of medical marijuana, the DEA and FDA still maintain that marijuana is not medicine. Last year, the FDA rejected a petition to remove marijuana from the Schedule I category due, in part, to studies that showed weed is addictive to monkeys and causes “increased merriment and appetite” in humans, according to documentsobtained last year from the FDA by VICE News.
The DEA noted in its announcement on Wednesday that it received public comments from people opposed to making synthetic THC products Schedule II while keeping marijuana Schedule I. The DEA also said “two commenters expressed concern that pharmaceutical companies are making a profit from approved drugs containing marijuana constituents.” “The DEA notes that FDA-approved products of oral solutions containing dronabinol [THC] have an approved medical use, whereas marijuana does not have an approved medical use and therefore remains in Schedule I,” the agency said in its response.
While developing its synthetic THC product, Insys has worked to keep real marijuana illegal. The company donated $500,000 last year to the successful campaign to defeat a marijuana legalization ballot initiative in Arizona. Insys said it opposed the measure because it “fails to protect the safety of Arizona’s citizens, and particularly its children.”