BLOGGER HTML TEMPLATE AS OF 4/15/16 BEFORE REDIRECTION TO WORDPRESS New Amsterdam Psychedelic Law Blog: Madmen Rule You, Part 11: Bringing together Oregon and ASA

Friday, April 20, 2012

Madmen Rule You, Part 11: Bringing together Oregon and ASA

In the ASA litigation, the petitioners argued that the DEA erred in failing to consider all available evidence of a currently accepted use for cannabis in treatment when it disregarded the medical judgment of sixteen states plus the District of Columbia, that cannabis has medical use, i.e. as demonstrated by their laws permitting the use of cannabis for medical purposes. The petitioners cited to the Supreme Court’s decision in Oregon, for the holding that “states have the authority to define general standards of medical practice.” They reasoned that the Government’s argument in that case to the effect that the fact that forty-nine states had not legalized physician-assisted suicide showed that that practice is not the legitimate practice of medicine contradicts the DEA’s argument that state medical cannabis laws are irrelevant to determining there is a medical use for cannabis. In conclusion, they argued that “given the traditional and well-recognized constitutional of states and medical practitioners to define the legitimate practice of medicine,” the DEA acted arbitrarily and capriciously in disregarding views of states and physicians and concluding that cannabis has no medical use.

In response, the DEA attempted to limit the significance of Oregon by treating it as limited to the case in which the Attorney General tried to restrict the ability of a physician to prescribe a drug by defining the scope of the legitimate practice of medicine; by contrast, the DEA said, the CSA explicitly delegates to the Attorney General (which means, in practice, the DEA, since the DEA acts on behalf of the Attorney General with regard to controlled substances) the authority to make scheduling decisions. It distinguished those scheduling decisions from the regulation of medical practice. It argued that the conclusions of states do not substitute for the requirement that the DEA and FDA conduct the state of current scientific knowledge concerning the drug (under the CSA’s eight-factor test) or rebut the FDA’s conclusion that research has not progressed to the point that cannabis can be considered to have a currently accepted medical use in treatment. Among other arguments in the DEA’s memorandum of law, the most noteworthy one is the naked and unsubstantiated assertion that “the federal agencies are not required to defer to the conclusions of the states” and these conclusions do not substitute for the “evidence-based considerations” required by the CSA.

There are two fundamental problems with the DEA’s reasoning. First, the DEA starts with the assumption that it has the authority to determine whether there is a currently accepted medical use in treatment and that it is not required to defer to the contrary conclusions of states – but whether it has that authority at all is exactly the issue in dispute! It starts with its own disputed conclusion and argues backwards from there. It is perfectly reasonable to say – to the contrary - that when sufficient evidence of state laws permitting the medical use of cannabis is presented to a DEA administrative law judge during the evidentiary hearing required by 21 USC 811(a), the judge must acknowledge those laws and rule according that there is a currently accepted medical use in treatment in the United States.

Second, although it’s a clever argument, it is impossible to separate (a) the power to define the scope of the legitimate practice of medicine from (b) the power to determine whether there is a “currently accepted medical use in treatment.” When the DEA states that it need not defer to the opinions of the states, which have the authority to regulate the practice of medicine, it necessarily claims even greater authority to regulate the practice of medicine because it says that it can second-guess the states or even ignore their opinions completely.

Third, when the DEA states that it is bound by the evidence-based standard of 21 USC 811(c), it again (willfully?) confuses two sets of standards. Section 811(c) sets forth the eight-factor test, which, as I have shown above, does not require any determination as to whether there is a currently accepted medical use at the stage of deciding whether to grant a petition and begin the evidentiary hearings. It requires only a consideration of the current state of scientific knowledge concerning the drug; the prerequisite that the FDA and DEA find that there is already a currently accepted medical use prior to granting the petition is the DEA’s own invention.

There is one final matter to consider here. The DEA cited to two decisions in support of its position. It cited to ACT II for the statement that the DEA is not required to abandon the need for “rigorous scientific proof” in favor of anecdotal reports even from doctors. At the time of the evidentiary hearings in that case, there were no medical cannabis laws in a third of the states, so this statement is irrelevant as to the question of whether the state laws prove there is a currently accepted medical use of cannabis in treatment. The DEA cited to the decision of Krumm v. Holder, No. Civ-08-1056, Lexis 52748 (D.N.M. 2009) by a trial-level federal court in New Mexico for the statement that “the CSA does not contemplate that state legislature’s determinations about the use of a controlled substance can be used to bypass the CSA’s rescheduling process.” However, in Krumm the plaintiff was seeking the far more radical judicial ruling that cannabis should be moved into Schedule I – not, as in the ASA case, that the DEA should just begin the evidentiary hearings required by the CSA to determine whether cannabis should be rescheduled. That decision did not say that state medical cannabis laws have no bearing on whether there is a medical use: it held that the necessary course for the plaintiff was to petition the DEA – which is exactly what ASA did.

1 Comments:

At July 19, 2012 at 7:02 AM , Anonymous Ricy Mardona said...

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