Thanks to Buford Terrell for directing my attention to Carl Olsen’s litigation in Iowa to compel the Iowa Board of Pharmacy to reclassify cannabis. I have only begun reading the documents at the Iowans for Medical Marijuana website but from what I have seen so far, the essential argument is that “medical use” is defined under STATE law, as opposed to FEDERAL law, and that the enactment of medical marijuana laws throughout the United States demonstrates that there is a currently accepted medical use of cannabis in the United States.
This issue goes to the heart of Schedule I and, therefore, all of U.S. drug control – the legal conclusion that there is no medical use of cannabis or, for that matter, any of the Schedule I psychedelics. The “medical use” issue is the fundamental battleground of the war and Carl is occupying that space.
It is fascinating for numerous reasons, including federalism as well as the assignment to federal police of the authority to determine what is a medicine.
I hope to present a more thorough treatment of the litigation but I invite others to review the material and offer their analyses.
2 thoughts on “Carl Olsen’s litigation in Iowa”
The issue dates back to the 1925 Supreme Court Decision in Lindner, holding that control of — and therefore the definition of — the practice is a part of the police power allocated to the States under the Constitution.
From its inception, the FDA has always recognized this limitation on its power. While all of us loosely talk about the FDA approving medicines, the FDA has always denied having any power to do so. The result of this is that the Federal government has no control over so-called off-label use. Once the FDA approves an NDA, doctors may prescribe that drug for any use, not just those for which it is labelled.
The FDA claims that all it does is enforce the law against false and deceptive advertising and that any drug marketed without the FDA-approved label is being marketed deceptively.
The Supreme court reaffirmed this doctrine that the Federal Government cannot interfer in the regulation of medical practice in 2005 in Gonzales v. oregon, the assisted suicide case.
Buford – the most interesting thing I have seen in waking memory is the test which the DEA announced in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) to define what is a currently accepted medical use in the United States, which the DEA cited in its December 19, 2008 letter to Carl Olsen rejecting his petition to reschedule cannabis. As I read the five-part test, the only one of the factors that plausibly relates to “accepted medical use” is number 4 – “the drug must be accepted by qualified experts.” The other four factors seem not related to whether there is a use in practice; instead they seem to relate either to (a) safety [factor 2], (b) efficacy [factor 3], and (c) some kind of academic assessment as to the state of knowledge about the substance [factors 1 and 5]. This test seems to sidestep almost entirely any evaluation as to any practitioners actually believe there is a medical use and instead imports tests of the other two statutory scheduling criteria, safety and efficacy, and another that is entirely irrelevant.