Madmen Rule You, Part 6: A federal appellate court rejects DEA’s reliance on FDA approval
When you travel around the world of medical cannabis advocacy, you will invariably encounter the argument that because the FDA has not “approved cannabis as a medicine” it is not a medicine. This is the colloquial way of saying that there is no “currently accepted medical use in treatment in the United States,” which is the precise statutory language, and therefore the states should not permit the use of cannabis for medical purposes (or, of course, cultivation and distribution of cannabis incidental to supplying the market).
What could be the source of this argument? The DEA’s persistent misstatement of the law.
In 1987, the Court of Appeals for the First Circuit ruled in Grinspoon v. Drug Enforcement Administration, 828 F.2d 887 (1st Cir. 1987) that in order to show the existence of a “currently accepted medical use in treatment” it is not necesssary that the FDA has approved a drug for marketing and sale in interstate commerce, i.e. approved a New Drug Application (“NDA”). In that case, Dr. Lester Grinspoon sought a hearing to challenge the DEA’s placement of MDMA in Schedule I. Although the DEA administrative law judge concluded after the hearing that MDMA did not belong in Schedule I, in part because there was a “currently accepted medical use in treatment,” in a now-familiar course of conduct, the DEA rejected the judge’s conclusion. The DEA Administrator stated in his decision that because the FDA had not approved a NDA to market MDMA in interstate commerce, MDMA had no “currently accepted medical use in treatment” and there was a lack of accepted safety or use of the drug or other substance under medical supervision (the latter corresponding to the third criteria for scheduling a drug - “safety”). In other words, the test for whether a drug belongs in Schedule I would be whether the FDA has approved it for sale, which would require a showing satisfactory to the FDA, based on exhaustive and extremely clinical trials, that it is “safe” and “effective” in treating some specific disease condition according to the standards promulgated by the FDA under the federal Food Drug & Cosmetic Act.
The Court of Appeals for the First Circuit rejected numerous arguments by the DEA in support of that standard, holding that a finding of “currently accepted medical use in treatment” does not require FDA approval. Fundamentally, the Court explained that FDA approval is not the same standard as “currently accepted medical use in treatment”: for example, a drug could have an acceptable safety standard and a currently accepted medical use in treatment even though it is not approved for marketing in interstate commerce (i.e. there is no “FDA approval”).
Most importantly, in its final section, the opinion focuses on what it considered the DEA’s attempt to define the CSA in a way that would make evidentiary hearings under 21 USC 811(a) irrelevant:
It is plain, therefore, that while Congress intended the recommendation of HHS [i.e. the FDA] 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 and, for participants like Dr. Grinspoon, would amount to an exercise in futility. We hesitate to interpret the CSA in a manner that would cause its important provision requiring a administrative hearing to be meaningless as to two of the three requirements for scheduling a substance in Schedule I. We believe instead that, for the hearing opportunity to be a significant one on these issues, the agency must remain flexible enough to weigh and consider claims raised at the administrative hearing to the effect that a substance has an accepted use and is accepted as safe even though it is not approved for distribution in interstate commerce.
The language of the opinion is strong. The DEA doesn’t care. I guarantee that the next time you hear the DEA and its minions and prohibitionist sympathizers among state officials and anti-drug activists object to the medical use of cannabis, they will say that cannabis has no medical use because the FDA has not approved it – as if no federal appellate court has rejected that position.