It is obvious that the DEA has defined the efficacy element of the five-factor test to mean that there were Phase III clinical trials compliant with the FDA’s requirements for the tests that must be included in a New Drug Application (i.e. application for approval to market a drug).
There is one simple problem about the DEA’s requirement of such efficacy studies: what are they? What are these mysterious efficacy studies which the DEA seeks to use as a test for “currently accepted medical use in treatment?” Who designs them? Who evaluates the results – the DEA? The FDA? Someone else? Under what rule? If someone does sponsor Phase I through Phase III clinical trials of cannabis and somehow determines which agency will evaluate the results – what results from these clinical trials constitute evidence of a “currently accepted medical use of cannabis”? As a practical matter, who is going to sponsor these clinical trials but not do so in the course of applying for a New Drug Application as to cannabis (since that is a requirement which Grinspoon rejected)? What kind of procedure exists for evaluating the results of Phase III clinical trials outside the scope of a New Drug Application? Does the FDA customarily do so under some arrangement with the DEA?
As the proponent of the efficacy test requirement, it is incumbent upon the DEA to provide answers to these questions.
The ultimate challenge to this element of the DEA’s test for a “currently accepted medical use in treatment” is in the last stage of the reasoning in the Grinspoon opinion.
As discussed above, the Court of Appeals for the First Appeal focused on the need for a meaningful hearing to evaluate whether there is a currently accepted medical use.
Here is the Court’s language (which I put in bold text in a previous section of this post):
It is plain, therefore, that while Congress intended the recommendation of HHS to have significant weight in the decisionmaking process, it also intended that there be an opportunity for a meaningful hearing after receipt of the HHS report. It would surely be anomalous if the FDA’s recommendation, based solely on the absence of approval for interstate marketing, sufficed to determine the ultimate conclusion prior to the hearing.
If we were to accept the Administrator’s construction of section 812(b)(1) in this case, the opportunity for a meaningful hearing would be lost, and satisfaction of the “accepted medical use” and “accepted safety” criteria would turn solely on the existence of FDA approval for interstate marketing. A hearing on issues of the sort required by the statute — Does the substance have an accepted medical use in treatment in the United States? Is the substance safe for use under medical supervision? — would be reduced to an empty formality…
In other words, the Grinspoon decision’s final reasoning was that whether there is a currently accepted medical use in treatment should be determined at a hearing, not before the hearing on the basis of the existence of or non-existence of FDA approval of a New Drug Application.
The same reasoning applies fully to the DEA’s requirement that there be “adequate and well-controlled studies proving efficacy.” DEA’s interpretation would turn on whether anyone has conducted Phase I-IIII clinical trials – and, presumably, submitted the results to the FDA or the DEA – but without the intention of obtaining an NDA. In the same way the Grinspoon said that under the DEA’s interpretation, “the opportunity for a meaningful hearing would be lost, and satisfaction of the “accepted medical use” and “accepted safety” criteria would turn solely on the existence of FDA approval for interstate marketing,” such an opportunity would be lost if the existence of an accepted medical use were to depend on the completion of Phase III clinical trials. The DEA’s current standards creates the same problem at issue in Grinspoon.
I think that what we have is a split between the First Circuit Court of Appeals and the D.C. Circuit Court of Appeals that should be resolved by the Supreme Court.