The Rescheduling of Marinol - comment

In early July Marinol was rescheduled under the CSA from Schedule II to Schedule III. I had requested that DEA hold a hearing prior to any rescheduling of Marinol. DEA declined. I indicated to this list that I would have comments on this development, but not until my attorneys and I had first reviewed DEA’s action and considered its various implications. For those of you who are interested, my comments on this matter follow below, after the following quote from DEA that reputes to describe my request.

"The one commenter who objected to the proposed rule, and requested a hearing thereon, asserted that Marinol should not be transferred to schedule III unless and until marijuana and all other THC-containing drugs are simultaneously and likewise rescheduled. This commenter asserted that Marinol has the same potential for abuse as marijuana and all other THC-containing drugs. This commenter agreed with the proposed rule that Marinol’s potential for abuse is less than the "high potential for abuse" commensurate with schedules I and II of the CSA.

Accordingly, this commenter agreed that Marinol should be transferred to a less restrictive schedule than schedule II. However, this commenter disagreed with what would be the resultant status of Marinol vis-a-vis marijuana and THC if the NPRM becomes final: Marinol would be in schedule III while marijuana and THC would remain in schedule I. This commenter asserted that the CSA prohibited transferring Marinol to a less restrictive schedule unless marijuana and all THC-containing drugs are simultaneously transferred to the same schedule. DEA has determined that this commenter’s objections are based on a misinterpretation of the CSA, which can be addressed, as a matter of law, without conducting a fact-finding hearing. Accordingly, as this commenter presented no material issues of fact, DEA denied this commenter’s request for a hearing." Federal Register: July 2, 1999 (Volume 64, Number 127, pg 35930)

The key words here are those that state that the issues I raised "can be addressed, as a matter of law, without conducting a fact-finding hearing." This is legal jargon for saying the DEA and I have different interpretations of the CSA and that they intend to stick to their own interpretation until someone gets the US Court of Appeals to order them otherwise.

The DEA’s interpretation of the CSA is a) that drugs with no medical use must be in schedule 1 regardless of any other factor, AND b) that dronabinol and THC (the same chemical) have a high potential for abuse UNLESS suspended in sesame oil and placed in a capsule. The US Court of Appeals ruled against argument (a) a long time ago, the question is whether or not (b) would survive judicial review. My attorneys and I think not, however we have decided not to appeal this issue at THIS time.

The DEA has stated to us in correspondance that the issues we have raised can be addressed in proceedings involving my original rescheduling petition. We will hold them to that comittment. They also point out that the recent rescheduling was of Marinol - dronabinol product suspended in sesame oil, and that pure dronabinol remains a schedule I substance as are all cannabinoids. The rescheduling petition I filed in 1995 includes both Marinol and pure dronabinol. As the DEA will be required to propose rules for the scheduling of marijuana, THC, and all cannabinoids (including pure dronabinol) in response to the petition—we have decided that it will be in both our and the public interest to wait to litigate issue (b) above at this future time rather than now. We also believe that since our petition was filed after the Unimed petition resulting in Marinol’s recent rescheduling, our call for the rescheduling of Marinol based on the review of all cannabinoids required by our petition is still a pending issue that can be addressed, if need be, at a later date.

The recent rescheduling of Marinol may be a positive precedent that supports the rescheduling of all cannabinoids, or it may become an additional obstacle. If it turns out to be an obstacle we believe we will have appropriate standing to appeal the relevant issues to the US Court of Appeals for resolution—because I had the original forsesight to include all cannabinoid substances in the July 1995 petition.

Whether or not the issues raised in my request for a hearing on Marinol truly represent issues of fact requiring a hearing or issues of law requiring judicial review, I believe, is a question best left to resolve when proceedings on all cannabinoids are complete. While I believe that Marinol is not an adequate substitute for marijuana for many medical patients, I do not believe that taking action to inconvenience patients who now have greater access to Marinol is in the public interest at this time. If indeed these issues need to go to the US Court of Appeals for clarification, I believe it will be in the interest of reform to submit the scheduling of all cannabinoid drugs and substances to the Court for judicial review rather than argue the legal issues as they apply narrowly to this one substance.

Meanwhile, as a result of correspondance on this matter, the DEA is more aware of the nuances of our case, and more importantly, thanks to a 10 page letter they sent us answering my objections in detail, we are more aware of the nuances of their case. Both of us want to think that we have the upper hand in the battle over rescheduling, but the important point to note is that this was just a skirmish—the main fight is still to come. On my side, we’ve elected to keep our powder dry and keep our eyes on the prize.