ASA Weighs in on DEA Rescheduling
November 28, 2007
From our friends at MAPS:
In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III. Wait a second, isn't MARINOL already in Schedule III? It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL's specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.Marinol's patent is almost up, which will open up the market to generic dronabinol, as long as the rule change goes through. ASA submitted a Public Comment in support of the proposed rule change. Here are some highlights:
Primarily, the proposed rule is a positive step because in it, the DEA acknowledges, only for the second time (Marinol was the first in 1986), the obvious medical benefits of THC/dronabinol. These proposed changes also represent progress because they implicitly recognize the value of whole-plant cannabis and its capacity to extract naturally occurring THC that is bioequivalent to synthetic THC... This proposed change is also a positive development because its will likely result in greater access for patients to less expensive, naturally derived cannabis-based drugs in the short term... Generic drugs, drugs that are produced and distributed without patent protection (and approved by the FDA under 21 U.S.C. 355 § 505(j)), are generally much cheaper than brand-name drugs, such as Marinol.We go on to argue that the rule change does not go far enough, and that the DEA needs to consider rescheduling other cannabinoids:
...the DEA should initiate another proposed rule change that reschedules a wide array of natural, non-psychoactive phytocannabinoids to support the research and development of a wider variety of cannabis-based medicines. Research suggests that the beneficial therapeutic effects of cannabis may result from the interaction, or synergy, among various cannabinoids. This helps to explain why medicines developed from whole-plant extracts may be more effective than single cannabinoid drugs developed from synthetic compounds. For instance, Sativex is a cannabis-based medicine, which combines both THC and CBD to produce an entirely different therapeutic potential than THC alone, has been developed by UK-based GW Pharmaceuticals, and has been approved for use in Canada and is undergoing clinical trials in Europe and the United States...And we further argue that the DEA should end the obstructions to medical cannabis research:
...the DEA should accept the opinion of its own U.S. Department of Justice-appointed Administrative Law Judge (ALJ) Mary Ellen Bittner, who urges the DEA to grant a license to Professor Lyle Craker to cultivate research-grade cannabis for distribution exclusively to federally approved researchers, which would greatly facilitate research on the therapeutic value of cannabis and access to its naturally derived constituent cannabinoids, specifically THC.Please read ASA's full comment and MAPS' comment.