Pharma's pot push

"[M]arijuana has no scientifically proven medical value." So stated the U.S. Drug Enforcement Administration (DEA) on Page 6 of a July 2010 agency white paper, titled "DEA Position on Marijuana."

Yet, only four months after the agency committed its "no medical pot" stance to print, it announced its intent to allow for the regulation and marketing of pharmaceutical products containing plant-derived THC — the primary psychoactive ingredient in cannabis.

But don't for a second believe the DEA has experienced a sudden change of heart regarding patients' use of the marijuana plant — use that is now legal under state law in 15 states and the District of Columbia (although recently approved laws in Arizona, New Jersey, and Washington, D.C., still await implementation). Despite growing public support for medical marijuana legalization, America's top anti-drug agency remains resolute that these hundreds of thousands of medi-pot patients are no more than common criminals, and their herbal remedy of choice is nothing more than the "Devil's weed."

It's not public pressure that's motivating the agency to consider rescheduling an organic cannabinoid for the first time since the creation of the U.S. Controlled Substances Act of 1970. (Under this act, all prescription drugs are classified as Schedule II, III, IV or V controlled substances, while all illicit substances are categorized as Schedule I drugs.) And it's not the recent publication of a series of FDA-approved "gold standard" clinical trials affirming the plant's safety and efficacy that's prompting the agency into action. (The DEA has so far refused to acknowledge these studies even exist.) Rather, the agency's sudden call for regulatory change is inspired by far more politically influential forces: The DEA is responding to the demands of Big Pharma.

The DEA initially made public its desire to recognize the use of marijuana plant-derived pharmaceuticals in a "notice of proposed rulemaking," which appeared in the Nov. 1, 2010 edition of the Federal Register.

The agency posted, "This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol formulation in Schedule III so that certain generic drug products are also included in that listing." (Marinol is the brand name for dronabinol, a prescription pill approved by the FDA in the mid-'80s that contains synthetic THC.)

Specifically, the DEA's intent is to expand the federal government's Schedule III listing to include pharmaceutical products containing naturally derived formulations of THC while simultaneously maintaining existing criminal prohibitions on the plant itself. "The DEA has received four petitions from companies that have products that are currently the subject of ANDAs (abbreviated new drug applications) under review by the FDA," its post reads. "While the petitioners cite that their generic products are bioequivalent to Marinol, their products do not meet Schedule III current definition provided above. Therefore, these firms have requested that 21 CFR 1308.13(g)(1) be expanded to include naturally derived or synthetically produced dronabinol."

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