The DEA Ruling of July 8, 2011, consists of two parts, a 2006 report and recommendation by the FDA and then the DEA’s own opinion.
Lets look at how a rescheduling petition works.
As discussed above, the CSA provides for a somewhat elaborate procedure for a petition to move a controlled substance from one Schedule to another, which is described at 21 USC 811.
Any “interested party” can petition the DEA to begin a proceeding to move a drug into another Schedule. (The DEA is arguing in the ASA case that the petitioners are not “interested parties” who can petition the DEA. I am not addressing this argument.)
The DEA is supposed to gather “necessary data” and then request a “scientific and medical evaluation” by the Department of Health and Human Services (“DHHS”) and a recommendation as to whether the drug should be moved to another Schedule. DHHS is the federal health and welfare department, a massive entity containing numerous subagencies, such as the Medicaid and Medicare agencies, the National Institutes of Health, the Centers for Disease Control and the FDA. It is the FDA that does the evaluation and makes the scheduling recommendation on behalf of DHHS, which is the term used in the CSA.
The CSA says that there are eight factors which the DEA and DHHS – which here means the FDA – must consider in evaluating whether to grant a petition for rescheduling which, agains, means an evidentiary hearing to determine whether to move the drug to another Schedule. Those factors are:
(1) the drug’s actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
21 USC 811(c)(emphasis added).
The CSA is a little convoluted, of course, being a federal statute. Although the DEA must consider these eight factors, first the FDA must consider factors (2) [scientific evidence of its pharmacological effect], (3) [the state of current scientific knowledge regarding the drug or other substance], (6) [what, if any, risk there is to the public health], (7) its psychic or physiological dependence liability, (8) [whether the substance is an immediate precursor of a substance already controlled under this subchapter], and any scientific or medical considerations involved in factors (1) [its actual or relative potential for abuse], (4) [its history and current pattern of abuse and (5) [the scope, duration, and significance of abuse]. The FDA is supposed to give its report on these factors to the DEA and give its recommendations as to the Schedule under which the drug should be listed. The FDA’s recommendations about the “scientific and medical matters” shall be binding on the DEA.
What is missing from the eight-factor test? Any evaluation of “currently accepted medical use in treatment” or “efficacy.” But that doesn’t stop the feds from sneaking it in.