In November of last year, the Drug Enforcement Administration (DEA) proposed a seemingly subtle change to its policy on marijuana. Citing recommendations from the assistant secretary for Health at the Department of Health and Human Services, the agency outlined its plan to reschedule pills containing organic dronabinol from schedule I to schedule III.
Dronabinol is short for tetrahydrocannabinol and long for THC. It’s more commonly known as the thing in marijuana that gets you high.
“This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules,” reads the DEA’s proposed rule. “This would have the effect of transferring the FDA-approved versions of such generic Marinol [a synthetic THC drug] products from schedule I to schedule III.”
Paul Armentano of the National Organization for Reform of Marijuana Laws reads the proposal as a way of legalizing marijuana so just Big Pharma can make money from it.
“DEA is taking a shortcut by saying, well, we can reschedule organic THC because it mimics an existing drug on the market,” Armentano said. “Which is ironic given that they are saying the organic substance is derivative of the synthetic substance that is actually based on the organic substance.”
A spokesperson from the DEA told The Daily Caller that the rescheduling of pills containing organic dronabinol is not equivalent to legalizing THC. “Please note that DEA is not ‘rescheduling … organic THC,’” wrote the DEA’s Rusty Payne in an e-mail.
“THC, natural or synthetic, remains a schedule I controlled substance. Under the proposed rule, in those instances in the future where FDA might approve a generic version of Marinol, that version of the drug will be in the same schedule as the brand name version of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant.”
In other words, THC in plant form or as an extract, will still be illegal. What won’t be illegal is if a pharmaceutical company buys THC from a government-licensed provider, puts it in a pill, receives the DEA’s stamp of approval, and sells it a price that will likely be far higher than the price of marijuana.
Armentano said such circular reasoning is a product of decades of hostility towards marijuana research.
“This is the insane rationale necessary for banning medical marijuana,” he said. “Take away the prohibition and the political elements, and you would never have the stretching of logic necessary to pass organic THC but only if it mimics Marinol.”
Payne protested the comparison. “Marinol is not the same thing as marijuana; nor is any generic version of Marinol that might be approved by the FDA in the future. Marijuana (the cannabis plant) contains approximately 500 different chemicals; and dronabinol (the form of THC found in Marinol) is just one of those numerous chemicals in the plant.”
he DEA’s proposed rule says that the agency will only entertain abbreviated new drug applications, the process by which most generics are approved when the patent expires on a branded drug. That means requiring an organic dronabinol drug to mimic Marinol may actually help get an organic pill on the market in record time.
Payne declined to say when the rules would pass. ”There is no timetable for the publication of the final rule. As with all proposed rules, DEA is required by law to give careful consideration to the public comments in deciding whether to finalize the rule.”
By Mike Riggs
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