Madmen Rule You, Part 7: The DEA proposes an alternative to the FDA-approval standard – the same thing

As I stated previously, the current petition to reschedule cannabis is the latest in a series of petitions. The first petition, commenced by the National Organization for the Reform of Marijuana Laws began in 1972. It ended in 1994 with the opinion issued by the Court of Appeals for the Federal Circuit in Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir. 1994).

This 20-year plus process actually did result in hearings at which physicians testified concerning the medical benefits of cannabis and resulted in the DEA Administrative Law Judge, Francis Young, holding that there is a “currently accepted medical use in treatment” for cannabis and it should not be in Schedule I. As was the case with MDMA, per the Grinspoon decision, the DEA Administrator rejected that conclusion.

After the Grinspoon decision, which was issued while NORML’s cannabis rescheduling was pending, it was necessary for the DEA to formulate a new legal standard to define “currently accepted medical use in treatment” that did not rely on FDA approval. Accordingly, the DEA formulated a new eight-factor test to define what is a “currently accepted medical use in treatment.”

The new test which the DEA issued to determined whether there existed a “currently accepted medical use in treatment” of a substance required:
(1) Scientifically determined and accepted knowledge of its chemistry;
(2) The toxicology and pharmacology of the substance in animals;
(3) Establishment of its effectiveness in humans through scientifically designed clinical trials;
(4) General availability of the substance and information regarding the substance and its use;
(5) Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;
(6) Specific indications for the treatment of recognized disorders;
(7) Recognition of the use of the substance by organizations or associations of physicians; and
(8) Recognition and use of the substance by a substantial segment of the medical practitioners in the United States.

In Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), the petitioners cited to Grinspoon and argued that the new eight-factor test invoked the same standard of FDA approval which the First Circuit had rejected. (Apparently the petitioners argued that the first three factors duplicate the elements of FDA approval and thus conflict with the Grinspoon holding; to my eye only the third factor duplicates dead-on the standard of FDA approval.)

In response, the Circuit Court misstated the holding of Grinspoon. Then it allowed the DEA to keep efficacy studies as a test for the existence of a “currently accepted medical use in treatment.”

The Court said:

“The present criteria, it is argued, duplicate a number of those original criteria. But the criteria challenged in Grinspoon included several elements, such as the availability of patent information or FDA-required labelling, which were necessary only to market the drug in interstate commerce. These criteria are clearly relevant to the FDA’s mission, but not to the DEA’s, see Grinspoon, 828 F.2d at 887. The First Circuit never suggested the DEA Administrator was foreclosed from incorporating and relying on those standards employed by the FDA that are relevant to the pharmaceutical qualities of the drug. The court merely held that while FDA approval is sufficient to establish the existence of an accepted medical use, the converse is not true — that absent FDA approval, commonly accepted medical use cannot be proven. Nor can we conceive of a reason the Administrator should be barred from employing notions developed by a sister agency insofar as those notions serve the missions of both agencies.”

(Emphasis added.)

In other words, although the DC Circuit Court acknowledged Grinspoon’s holding that FDA approval of a drug for marketing is not the way to establish the existence of a currently accepted medical use in treatment, it held that the DEA could require elements of what the FDA would require in order to approve a drug for interstate marketing, specifically efficacy studies. (It also apparently held that FDA approval can establish the existence of a currently accepted medical use in treatment, but is not the only way to do so.)

For reasons that are not important here, the next thing that happened was that the DEA replaced the eight-factor test for the existence of a “currently accepted medical use in treatment” with a new five-factor test, which is the one which the DEA currently uses. Although it discarded numerous elements from the eight-factor test, it retained efficacy and safety studies as its required elements. This standard appeared in Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir. 1994).

The five-factor standard that the court allowed to stand is as follows:

i. The drug’s chemistry must be known and reproducible
ii. There must be adequate safety studies
iii. There must be adequate and well-controlled studies proving efficacy
iv. The drug must be accepted by qualified experts
v. The scientific evidence must be widely available

There is one simple problem with the DEA’s requirement of efficacy studies as an element of a “currently accepted medical use in treatment”: what are they? The standards for proving efficacy and safety in order to obtain FDA approval of a New Drug Application are relatively well-known. They are discussed at length in FDA regulations and guidance documents and constitute a significant element of the huge costs that go into bringing a drug to market. What, however, 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 evaluate the results – the DEA? The FDA? Someone else? Under what rule? Apparently the D.C. Court of Appeals was not troubled by these questions.

Apparently the petitioners did not continue to object to the Court’s apparent approval of the DEA’s inclusion of “adequate and well-controlled studies proving efficacy” or, for that mater, “adequate safety studies.”

The five-factor test is the present test for “currently accepted medical use in treatment.” It is the one which the DEA used to reject the current rescheduling petition.

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