DEA recently issued this notice of proposed rulemaking to remove a Schedule II substance, Samidorphan, from the Controlled Substances Act's schedules altogether. See 21 U.S.C. 811(a) (permitting DEA to add/move/remove substances to/among/from the schedules); id. 812(b) (the schedules). I think it might be a big deal because as far as I know at least, it marks the first time that DEA and HHS have decontrolled a substance (removed it from the schedules altogether) despite concluding that it has "no currently accepted medical use in treatment in the United States." In fact, to my knowledge, this is the first time DEA/HHS have put a drug with no currently accepted medical use anywhere other than the CSA's most restrictive schedule--Schedule I.

Matt Zorn and I are currently representing Dr. Sue Sisley, Scottsdale Research Institute, and several veterans in a Ninth Circuit lawsuit challenging the decades-old (and, in my view, unlawful) five-part test DEA has traditionally applied to assess whether a drug has a currently accepted medical use. Unless I'm misreading it, this NPRM appears either to abandon that standard or at least to ignore its implications. If that's right, this strikes me as a very big deal. In the post below, I attempt to sketch out a basic introduction to the relevant CSA provisions before discussing the NPRM.  

CSA Schedules and Scheduling: The Basics

To the uninitiated, the CSA's schedules can be confusing. The following summary is going to oversimplify things a bit--but only a bit. Under 21 U.S.C. 812(b), DEA and FDA must evaluate a substance’s abuse potential, accepted medical use, dependence, and safety for use under medical supervision as part of the process for determining whether and where to schedule (or deschedule or reschedule) a substance under the CSA. Section 811(c) requires FDA to provide DEA a scientific and medical evaluation of the substance as well as a scheduling recommendation based on FDA's examination of eight specific factors:

FDA's recommendations as to scientific and medical matters are binding on DEA. 21 U.S.C. 811(b). If FDA recommends that a substance not be controlled, DEA is statutorily forbidden from scheduling it. Id. And finally, "[i]f DEA determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be ...."

DEA received a petition from Samidorphan's maker Alkermes Inc. in April 2014. According to Alkermes Inc., DEA should remove Samidorphan from Schedule II because it "lacks abuse or dependence risk.” At this point, you need to understand the schedules.

Schedule I drugs:

  1. high potential for abuse;
  2. no currently accepted medical use in treatment in the United States; and
  3. There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Schedule II drugs:

  1. high potential for abuse;
  2. a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions;
  3. abuse of the drug or other substances may lead to severe psychological or physical dependence.

Schedule III drugs:

  1. a potential for abuse less than the drugs or other substances in schedules I and II;
  2. a currently accepted medical use in treatment in the United States; and
  3. abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV drugs:

  1. a low potential for abuse relative to the drugs or other substances in schedule III;
  2. a currently accepted medical use in treatment in the United States; and
  3. abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

Schedule V drugs:

  1. a low potential for abuse relative to the drugs or other substances in schedule IV;
  2. a currently accepted medical use in treatment in the United States;
  3. abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

Time for a Pop Quiz

Now, I know that's a lot, but zero in on the criteria for Schedules I and II. Read them again, and really pay attention. Okay, now here's the question: what do you do with a drug with the following characteristics?

  1. No potential for abuse;
  2. No currently accepted medical use in treatment in the United States; and
  3. Abuse of the drug or other substance won't lead to severe psychological or physical dependence.

DEA's New NPRM and Why I Think It Might Be a Big Deal

For years, DEA has insisted that the only schedule for drugs with no currently accepted medical use is Schedule I. Gonzales v. Raich, 545 U.S. 1, 27 (2005) ("The CSA designates marijuana as contraband for any purpose; in fact, by characterizing marijuana as a Schedule I drug, Congress expressly found that the drug has no acceptable medical uses."). But a colleague of mine who also studies the CSA, Matt Zorn, and I have long wondered why the drug I described above shouldn't be off the schedules altogether. Well, it appears DEA and FDA read our minds.

After undertaking the process I described above, DEA concluded that Samidorphan has the pattern of characteristics I just described--no potential for abuse, no currently accepted medical us, and abuse won't lead to dependence. Confronted with that pattern, DEA concluded that Samidorphan not only doesn't meet the requirements for inclusion in Schedule II, but it also doesn't belong in any other schedule either. As a result, DEA has proposed to remove it from the schedules altogether.

What I find so fascinating is DEA's explanation of each of the finding--especially the one in the second screenshot below:

That "no currently accepted medical use" discussion shocked me. As already mentioned, settled law in this area dictates that drugs with no accepted medical use in the U.S. must go to Schedule I, go directly to Schedule I, do not pass Go, and do not collect $200. E.g., 84 FR 20023-02 (DEA May 8, 2019) (“Congress established only one schedule—schedule I—for drugs of abuse with ‘no currently accepted medical use in treatment in the United States.'").

Is everything about to change? Let me know what you think!

DEA Proposes to Decontrol Drug With No Currently Accepted Medical Use?!
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