Opinion ID: 494127
Heading Depth: 2
Heading Rank: 3

Heading: Reliance Upon HHS Evaluation And Recommendation.

Text: 75 Dr. Grinspoon's final dissatisfaction with the final rule is the Administrator's alleged reliance on the conclusions recommended by HHS on the criteria enumerated in section 812(b)(1). Grinspoon argues that the determination by the Secretary of HHS was arbitrary and capricious and not in accordance with law, and that all relevant scientific and medical evidence was not before the Secretary at the time of the determination. The record, in fact, reveals that HHS performed in a less than admirable fashion in making its recommendation to the Administrator. The record indicates that HHS failed to look beyond its own files upon receiving the Administrator's section 811(b) request for a scientific and medical evaluation; neglected to consult any organization of medical professionals or even the FDA's own panel of experts, the Drug Abuse Advisory Committee; and simply rubber-stamped the Administrator's conclusion by adopting the section 811(c) eight-factor analysis already performed by the DEA. There is also evidence that FDA analysts failed to forward a letter received from the National Institute of Drug Abuse, which stated that the evidence cited by the DEA did not support the existence of abuse potential in animals, to either the FDA Commissioner or the Assistant Secretary of HHS prior to the issuance of the HHS recommendation to the Administrator. 17 76 Despite these alleged procedural shortcomings, we fail to see how the procedure followed by HHS tainted the Administrator's determination. The CSA does not specify the steps to be taken by HHS; it simply requires the Administrator to request from the Secretary of HHS a scientific and medical evaluation. 21 U.S.C. Sec. 811(b). Moreover, the HHS recommendation to schedule a substance is not binding 18 and, indeed, serves to trigger an administrative hearing at which interested persons may introduce evidence to rebut the Secretary's scheduling recommendation. Ultimately, of course, responsibility rests with the Administrator, not HHS, to ensure that the final rule rests on permissible legal standards and substantial evidence. It is true that the Administrator twice mentioned the HHS recommendation in his final rule, once in relation to the accepted medical use criterion and once in relation to the high potential for abuse criterion. With regard to the first mention, however, we have already determined that this aspect of the case must be remanded and reconsidered because the Administrator interpreted the statutory language in a manner that is contrary to the intent of Congress. Because, on remand, the Administrator will not be able to rely on lack of FDA approval to demonstrate the absence of an accepted medical use, we need not discuss any possible reliance on the HHS recommendation regarding the absence of an accepted medical use. With regard to the second mention, we believe that the Administrator's conclusion that MDMA has a high potential for abuse is amply supported by a substantial amount of independent evidence. Because we believe that the Administrator's finding with regard to MDMA's potential for abuse is justified even in the absence of the HHS recommendation to place MDMA in Schedule I, we hold that any reliance on the HHS evaluation by the Administrator constitutes, at most, harmless error. 77 For the foregoing reasons, the rule is vacated and remanded to the Administrator for further proceedings consistent with this opinion.