Cannabis Stays Schedule 1 – Blame DEA, but Also Blame HHS.

As you already know, the DEA decided not to reschedule cannabis, and maintain its Schedule I status under the Controlled Substances Act.

In the coming days and weeks, there will be much analysis of the actual decisions – find them here and here.

This is certainly disappointing, albeit quite predictable.

I will be sharing more thoughts soon, but I wanted to make sure one thing is not lost: while the US Drug Enforcement Administration, Department of Justice, and Obama Administration deserve their share of blame, do not lose sight of the blame that rests with the U.S. Health and Human Services department.  HHS paved a clear course for the DEA to follow in denying the rescheduling request.  Here is their letter in full (starting on page 6):

Department of Health and Human Services, Office of the Secretary Assistant Secretary for Health, Office of Public Health and Science Washington D.C. 20201. June 25, 2015. The Honorable Chuck Rosenberg Acting Administrator, Drug Enforcement Administration, U.S. Department of Justice, 8701 Morrissette Drive, Springfield, VA 22152

Dear Mr. Rosenberg:

Pursuant to the Controlled Substances Act (CSA, 21 U.S.C § 811(b), (c), and (f)), the Department of Health and Human Services (HHS) is recommending that marijuana continue to be maintained in Schedule I of the CSA.

The Food and Drug Administration (FDA) has considered the abuse potential and dependence-producing characteristics of marijuana.

Marijuana meets the three criteria for placing a substance in Schedule I of the CSA under 21 U.S.C 812(b)(1). As discussed in the enclosed analyses, marijuana has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Accordingly, HHS recommends that marijuana be maintained in Schedule I of the CSA. Enclosed are two documents prepared by FDA’s Controlled Substance Staff (in response to petitions filed in 2009 by Mr. Bryan Krumm and in 2011 by Governors Lincoln D. Chafee and Christine O. Gregoire) that form the basis for the recommendation. Pursuant to the requests in the petitions, FDA broadly evaluated marijuana, and did not focus its evaluation on particular strains of marijuana or components or derivatives of marijuana.

FDA’s Center for Drug Evaluation and Research’s current review of the available evidence and the published clinical studies on marijuana demonstrated that since our 2006 scientific and medical evaluation and scheduling recommendation responding to a previous DEA petition, research with marijuana has progressed. However, the available evidence is not sufficient to determine that marijuana has an accepted medical use. Therefore, more research is needed into marijuana’s effects, including potential medical uses for marijuana and its derivatives. Based on the current review, we identified several methodological challenges in the marijuana studies published in the literature. We recommend they be addressed in future clinical studies with marijuana to ensure that valid scientific data are generated in studies evaluating marijuana’s safety and efficacy for therapeutic use. For example, we recommend that studies need to focus on consistent administration and reproducible dosing of marijuana, potentially through the use of administration methods other than smoking. A summary of our review of the published literature on the clinical uses of marijuana, including recommendations for future studies, is attached to this document. 7

FDA and the National Institutes of Health’s National Institute on Drug Abuse (NIDA) also believe that work continues to be needed to ensure support by the federal government for the efficient conduct of clinical research using marijuana. Concerns have been raised about whether the existing federal regulatory system is flexible enough to respond to increased interest in research into the potential therapeutic uses of marijuana and marijuana-derived drugs. HHS welcomes an opportunity to continue to explore these concerns with DEA.

Should you have any questions regarding theses recommendations, please contact Corinne P. Moody, Science Policy Analyst, Controlled Substances Staff, Center for Drug Evaluation and Research, FDA, at (301) 796-3152.

Sincerely yours, Karen B. DeSalvo, MD, MPH, MSc Acting Assistant Secretary for Health

 

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