DEA Proposes to Expand Definition of Dronabinol Drugs Classified in Schedule III
October 1, 2007On September 24, 2007, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking that would expand the classification of dronabinol, commonly known as delta-9-tetrahyrdocannabinol (“THC”), as a Schedule III controlled substance under the Controlled Substances Act.
THC is a federally-controlled Schedule I controlled substance. Currently, only MARINOL (dronabinol), an FDA-approved synthetic formulation of dronabinol in sesame oil and encapsulated in a soft gelatin capsule, is regulated as a Schedule III controlled substance. DEA created the schedule classification for MARINOL based on the fact that the formulation greatly diminishes the potential for THC abuse. DEA states that the Agency has received information that several companies are pursuing approval of ANDAs for generic versions of MARINOL based on the fact that the formulations would meet the statutory approval requirements because they have the same active ingredient, strength, dosage form and route of administration as MARINOL, and are bioequivalent. DEA notes that neither FDC Act § 505(j) (ANDA approval) nor FDA’s regulations requires solid oral dosage forms such as capsules proposed for approval in ANDAs to contain the same inactive ingredient as the listed drug. DEA notes that FDA recognizes that an ANDA sponsor referencing MARINOL could propose a capsule for approval with an inactive ingredient other than sesame oil, even though the “Marinol” referenced is not the product defined in the DEA regulation.
DEA’s proposed rule would expand the classification of dronabinol products in Schedule III to include tablets and capsules, not just soft gel capsules. The rule would also allow for classification of both synthetic and natural (derived from the cannabis plant) dronabinol products in Schedule III. DEA reasons that for the purposes of the proposed rule, generic dronabinol can be substituted for MARINOL “with the full expectation that the generic drug will produce the same clinical effect and safety profile as the innovator drug.” DEA also notes that the Agency expects that the “eight-factor analysis,” which is used to determine a drug’s potential for abuse, would examine the same medical, scientific, and abuse data for the innovator and the generic drug. DEA is indicating that the abuse liability of a tablet or capsule as well as naturally-derived THC is likely to be the same as MARINOL. Note, however, that under the proposed rule DEA will still have to make scheduling decisions on non-oral dronabinol dosage forms.
Procedurally, DEA’s proposed rule will preempt the need for the Agency to conduct a separate scheduling action for each ANDA dronabinol product approved by FDA. DEA notes that this will save Agency resources.
Written comments on the proposed rule must be postmarked, and electronic comments sent, on or before November 23, 2007.