Opinion ID: 494127
Heading Depth: 1
Heading Rank: 3

Heading: Challenges Based on Arbitrary and Capricious

Text: 52 Standard. 53 Although a remand is necessary due to our above holding, we nonetheless feel compelled to address the other issues raised in Dr. Grinspoon's petition because they are likely to arise again when the Administrator reconsiders the rule. 54
55 In addition to the accepted medical use and accepted safety criteria discussed above, the CSA also requires substances identified for placement in Schedule I to have a high potential for abuse. 21 U.S.C. Sec. 812(b)(1)(A). Dr. Grinspoon contends that the Administrator's placement of MDMA in Schedule I is arbitrary and capricious because the Administrator failed to articulate a legal standard for assessing MDMA's potential for abuse and because the evidence in the record is insufficient to support a finding that MDMA has a high potential for abuse. While conceding that MDMA has some potential for abuse, and therefore should be scheduled under the CSA, Dr. Grinspoon insists that the Administrator has not proved, as he must for a Schedule I substance, that MDMA's potential for abuse is high. 56
57 The CSA provides no definition of the phrase high potential for abuse, but both parties agree that the legislative history of the statute provides guidance in this regard. Specifically, the report of the House Committee on Interstate and Foreign Commerce accompanying the bill that eventually became the CSA sets forth four alternative legal standards for determining when a substance possesses a potential for abuse. Borrowing from regulations promulgated under the FDCA, the House Committee Report provides that the Administrator may determine a substance has potential for abuse if: 58 (1) There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or of the community; or 59 (2) There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or 60 (3) Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or 61 (4) The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community. 62 House Committee Report, supra, at 4601. The Committee Report goes on to state that potential for abuse exists only when there is a substantial potential for the occurrence of significant diversions from legitimate channels, significant use by individuals contrary to professional advice, or substantial capability of creating hazards to the health of the user or the safety of the community. House Committee Report, supra, at 4602. 63 The Administrator argues that he applied the standards expressly approved by Congress, but Dr. Grinspoon complains that the Administrator articulated no standard for showing that MDMA had a relative potential for abuse sufficient to warrant placement in Schedule I. As Grinspoon notes, the passage from the legislative history quoted above provides guidance only as to the minimum needed to show any potential for abuse, in other words, enough to justify a level of CSA control as low as placement in Schedule V. It offers no guidance for assessing whether a substance should be subject to Schedule I controls, the strictest imposed under the CSA, which require a high potential for abuse. For this, argues Grinspoon, the Administrator must prove that MDMA has a high potential for abuse relative to other scheduled substances and must base its proof on existing levels of actual abuse on the streets. 64 While we acknowledge that the Administrator's final rule is silent with respect to the legal standard required for a finding of high potential for abuse, we do not find the Administrator's action to be arbitrary and capricious. The fourth standard contained in the segment of the Committee Report quoted above makes it quite clear that the Administrator can permissibly reach a conclusion regarding a substance's level of potential for abuse by comparing the substance to drugs already scheduled under the CSA. Here the Administrator has done just that, offering several findings concerning the evidence of close structural and pharmacological similarity between MDMA and other substances, such as MDA, 12 which already have been found to have a high potential for abuse and have been placed in Schedule I or II. 51 Fed.Reg. 36,555-57 (1986). The Administrator also cited animal studies, human behavioral studies, and a survey of MDMA users which suggest that MDMA is related in its effects to Schedule I and II substances such as LSD, cocaine, mescaline, and MDA. 13 We believe this approach to ascertaining MDMA's potential for abuse is entirely consistent with the statutory scheme developed by Congress and therefore hold that the Administrator's method is not arbitrary and capricious. 14 The question remains, of course, whether the evidence collected by the Administrator is sufficient to justify his conclusion that MDMA has a high potential for abuse. Since Dr. Grinspoon has also challenged this aspect of the scheduling determination as arbitrary and capricious, we turn next to a discussion of this issue. 65
66 In reviewing the Administrator's conclusion regarding MDMA's potential for abuse, we must determine whether it is based on substantial evidence, a term the Supreme Court has defined as  'such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.'  American Textile Manufacturers Institute, Inc. v. Donovan, 452 U.S. 490, 522-23, 101 S.Ct. 2478, 2497, 69 L.Ed.2d 185 (1981) (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477, 71 S.Ct. 456, 459, 95 L.Ed. 456 (1951)). The Court has further explained this lenient standard of review, stating that  'the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency's findings from being supported by substantial evidence.'  Id. (quoting Consolo v. Federal Maritime Commission, 383 U.S. 607, 620, 86 S.Ct. 1018, 1026, 16 L.Ed.2d 131 (1966)). In other words, [e]ven if reasonable minds could also go the other way, we must uphold the [agency] if its ultimate finding is supported by substantial evidence in the record as a whole. NLRB v. J.K. Electronics, Inc., 592 F.2d 5, 7 (1st Cir.1979). 67 The question before us, therefore, is whether there is substantial evidence in the administrative record to support the Administrator's determination that MDMA is so related in [its] action to a drug or drugs already listed as having a [high] potential for abuse that it is likely MDMA will have the same potentiality for abuse as such drugs. House Committee Report, supra, at 4601. In support of his conclusion, the Administrator made 46 numbered findings related to MDMA's similarity to other drugs with a high potential for abuse. These findings were based on scientific evidence concerning the chemical structural similarity between MDMA and other Schedule I and II drugs; the similar pharmacological effects of MDMA and these other drugs; animal drug discrimination studies; animal self-administration studies; and recent studies of the neurotoxic effects of MDMA and related drugs on rats. Based on this evidence, the Administrator found, among other things, that (1) MDMA is the N-methyl analogue of MDA and retains the psychomimetic properties of MDA; (2) MDMA produces pharmacological effects in common with both central nervous system (CNS) stimulants like amphetamine and hallucinogens like MDA in animals; (3) MDMA and MDA produce the same spectrum of pharmacological effects in mice, dogs, and monkeys when observed during toxicity studies; (4) MDMA, like MDA, amphetamine, and methamphetamine, produces neurotoxic effects when administered to animals; (5) MDMA and MDA may both produce the same neurotoxic effects to serotonergic nerves in humans; (6) in drug discrimination tests, rats trained to recognize amphetamine also recognized MDA and MDMA, and rats trained to recognize MDA also recognized MDMA; (7) based on recent tests involving human subjects, MDMA can be described as maintaining the same potency as MDA, but exhibiting subtle differences in the qualitative nature of the intoxication. 68 Dr. Grinspoon, in an item-by-item analysis contained in the proposed findings of fact and conclusions of law he submitted to the DEA, calls into question many of the Administrator's findings concerning MDMA's similarity to other drugs with a high potential for abuse. For instance, Grinspoon agrees that MDMA is a member of a family of psychoactive drugs, but disputes the validity of the inference drawn from the similarity by the Administrator. According to Grinspoon, chemical similarity is not necessarily a good guide to the actual effects of a compound in the human body. Petitioner's Brief at 37. Grinspoon notes that of the 28 known phenethylamines, 17 were not scheduled under the CSA as late as December 1983. Even a subsequent review of these 17 substances by the World Health Organization's Expert Committee on Drug Dependence resulted in a recommendation that only nine of the substances be scheduled by member nations. Eight were thought harmless enough to remain unscheduled. 15 Also, referring to the Administrator's finding that MDMA, like MDA and amphetamine, is a central nervous system stimulant, Grinspoon asserts that this evidence of pharmacological similarity proves nothing. Several other substances also fit this description, including caffeine and six of the eight phenethylamines that are neither currently controlled nor recommended for control by WHO. Based on this, Grinspoon concludes that the mere fact that a substance is a CNS stimulant does not necessarily imply that it has a high potential for abuse. 69 In addition, Dr. Grinspoon (1) attacks the Administrator's other findings concerning MDMA's LD-50 rating 16 as being irrelevant to the potential for abuse inquiry; (2) discounts the importance of findings that MDMA is neurotoxic when administered to rats; (3) questions the relevancy of the findings related to animal drug discrimination studies; and (4) asserts that the Administrator has incorrectly interpreted the results of two animal self-administration studies. We have reviewed Dr. Grinspoon's item-by-item analysis closely, but find no basis sufficient to overturn the Administrator's decision. Grinspoon's reinterpretation of the scientific evidence before the agency surely demonstrates that the available evidence does not inexorably lead to a conclusion that MDMA is similar to drugs possessing a high potential for abuse. But, faced with such uncertainty, we must defer to the conclusion reached by the Administrator, even if we may have favored Dr. Grinspoon's approach had we studied the evidence in a de novo fashion. In reaching this conclusion, we follow the well-established maxim that [w]here the agency presents scientifically respectable evidence which the petitioner can continually dispute with rival, and we will assume, equally respectable evidence, the court must not second-guess the particular way the agency chooses to weigh the conflicting evidence or resolve the dispute. Asarco, Inc. v. OSHA, 746 F.2d 483, 490 (9th Cir.1984) (quoting United Steelworkers of America v. Marshall, 647 F.2d 1189, 1263 (D.C.Cir.1980), cert. denied, 453 U.S. 913, 101 S.Ct. 3148, 69 L.Ed.2d 997 (1981)). We find this maxim to have particular force in a case such as this because, as one court has explained, [a]ppellate courts have neither the expertise nor the resources to evaluate complex scientific claims. Thompson Medical Co. v. FTC, 791 F.2d 189, 196 (D.C.Cir.1986), cert. denied, --- U.S. ----, 107 S.Ct. 1289, 94 L.Ed.2d 146 (1987). 70
71 Dr. Grinspoon also takes issue with the Administrator's alleged failure to consider evidence tending to show that placement of MDMA in Schedule I would strongly discourage medical research on the drug. Grinspoon contends that failure to consider the impact of a scheduling decision on legitimate research amounts to arbitrary and capricious action on the part of the Administrator because he did not weigh all relevant factors in making his decision. Motor Vehicle Manufacturers Association v. State Farm Mutual Insurance Co., 463 U.S. 29, 42-43, 103 S.Ct. 2856, 2866, 77 L.Ed.2d 443 (1983). To buttress his contention, Grinspoon recites a litany of legal, administrative, and practical obstacles that hinder researchers seeking to conduct experiments with Schedule I drugs. These obstacles include mandatory FDA approval of research involving Schedule I substances, 21 C.F.R. Sec. 1301.42(a)-(c); mandatory special registration with the DEA, 21 C.F.R. Secs. 1301.33, 1301.42; mandatory reporting and security procedures beyond those required for drugs placed in Schedules II through V; unavoidable bureaucratic delays; and other adverse impacts due to the grave concern caused by a substance's placement in Schedule I, such as difficulty in obtaining volunteers for clinical studies and, for academic researchers, difficulty in securing approval from institutional review boards. 72 Again, we do not doubt that Dr. Grinspoon has correctly identified several ways in which the placement of MDMA in Schedule I will impede his research and the efforts of other researchers interested in exploring the possibility of clinical uses for MDMA. We must conclude, nevertheless, that the existence of such hurdles does not render the Administrator's scheduling decision arbitrary and capricious. First, it is simply untrue that the Administrator failed to consider the impact on medical research that would be caused by a decision to place MDMA in Schedule I. In the final rule, the Administrator states explicitly that he read with interest the comments from various parties in the record concerning the effect placement of MDMA into Schedule I would have on legitimate research into the substance. 51 Fed.Reg. 36,559 (1986). After several paragraphs discussing the contours of the additional Schedule I controls, the Administrator concludes that those who wish to conduct research with MDMA have available avenues by which to pursue such research. Id. 73 Second, and more importantly, Dr. Grinspoon has identified nothing in the CSA, its legislative history, or its implementing regulations that can be read to require the Administrator to consider the impact of a scheduling determination upon legitimate scientific research. From our review of the CSA, we can only conclude that Congress has already weighed the costs and benefits of legitimate research on dangerous drugs and has determined, in a categorical manner, that if the three Schedule I criteria are satisfied, see 21 U.S.C. Sec. 812(b)(1), then the substance should be subject to Schedule I controls even if this action will create administrative and other burdens for researchers. Here there is no dispute that the Administrator considered all of the section 812(b)(1) criteria in arriving at his final rule, so we are left with a situation in which there can be no complaint that the Administrator failed to consider any relevant factor. 74
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.