Grinspoon v. DEA

COFFIN, Circuit Judge.

On November 13, 1986, the Administrator of the Drug Enforcement Administration ("DEA") issued a final rule placing the substance 3,4-methylenedioxymethamphe-tamine ("MDMA") into Schedule I of the Controlled Substances Act ("CSA"), 21 U.S.C. §§ 811, 812 (1987).¹ 51 Fed.Reg. 36,552 (1986). In reaching this decision, the Administrator found that MDMA met all three of the statutory requirements for classification as a Schedule I substance, namely, (1The Act established five categories of substances whose manufacture and distribution are subject to federal control. The Act’s initial scheduling of substances can be found in 21 U.S.C. § 811. These listings are subject to amendments and additions pursuant to 21 U.S.C. § 811. Substances placed into Schedule I are subject to the most severe controls and penalties imposed by the Act.

A) The drug or other substance has a high potential for abuse. (

B) The drug or other substance has no currently accepted medical use in treatment in the United States. (

C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

21 U.S.C. § 812(b)(1).

Dr. Lester Grinspoon, a psychiatrist and faculty member of the Harvard Medical School, petitions this court to review the final rule. Dr. Grinspoon seeks to conduct research on the therapeutic use of MDMA and believes that the imposition of Schedule I controls will effectively foreclose such research. He cites four reasons for vacating the Administrator's scheduling determination. The first reason advanced is that the Administrator applied the wrong legal standards for "currently accepted medical use in treatment in the United States" and *883 for "accepted safety for use ... under medical supervision" in 21 U.S.C. § 812(b)(1). The other three reasons contained in Dr. Grinspoon's petition challenge the scheduling determination as arbitrary and capricious because (a) the Administrator's determination that MDMA had a "high" potential for abuse was flawed by his failure to articulate a legal standard and his reliance on insufficient record evidence; (b) the Administrator failed to give adequate weight to the evidence showing that placing MDMA into Schedule I would create a barrier to medical research on the drug; and (c) the rule is based upon incomplete and arbitrary recommendations from the Secretary of Health and Human Services. Petitioner urges this court to remand the ease to the DEA with instructions to place the substance MDMA into Schedule III.

Although we are satisfied that these final three claims do not require us to overturn the rule, we believe that Dr. Grin-spoon's first claim has considerable merit and requires us to remand the scheduling determination for reconsideration by the Administrator. After describing the administrative history of the rule, we shall consider each of petitioner's claims in turn.

I. Administrative History.

In January of 1984, the DEA prepared a document entitled "Schedule I Control Recommendation Under the CSA for 3,4-Me-thylenedioxymethamphetamine (MDMA)." The control recommendation, which was based upon information compiled from various DEA data sources and scientific and medical literature, considered all three Schedule I criteria listed in section 812(b)(1) and concluded that (1) MDMA has a high potential for abuse; (2) MDMA has no known legitimate medical use for treatment in the United States; and (3) there is a lack of accepted safety for the use of MDMA under medical supervision. Based upon these findings, the DEA recommended that MDMA be placed into Schedule I of the CSA.

In March of 1984, pursuant to the procedures set out in the CSA, 28 U.S.C. 811(b),² the Administrator submitted the DEA's control recommendation to the Assistant Secretary for Health of the Department of Health and Human Services ("HHS") for scientific and medical evaluation and for an HHS recommendation as to whether MDMA should be controlled. The HHS evaluation was conducted by Dr. Charles Tocus, Chief of the Drug Abuse Staff of the Food and Drug Administration ("FDA"). Dr. Tocus stated in his affidavit that he searched the FDA files and found no reference to MDMA. Based upon this absence of information in the FDA files and a review of the information contained in the DEA control recommendation carried out by Dr. Tocus, HHS responded by making minor (typographical) corrections in the DEA's eight-factor analysis³ and concurring in the recommendation that MDMA be placed into Schedule I.221 U.S.C. § 811(b) provides that The Attorney General shall, before initiating proceedings under subsection (a) of this section to control a drug or other substance..., and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled.3Section 811(c) requires the Administrator to consider the following eight factors for each drug proposed to be controlled under the CSA: (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 U.S.C. § 811(c).

Upon receiving the HHS evaluation and recommendation, the Administrator issued a Notice of Proposed Rulemaking with regard to placing MDMA into Schedule I of the CSA. 49 Fed.Reg. 30,210 (1984). Later, following the receipt of several comments *884 and requests for a hearing, the Administrator referred the matter to an Administrative Law Judge ("AU") with instructions to "conduct a hearing for the purpose of receiving factual evidence and expert opinion regarding the proposed scheduling of MDMA." 51 Fed.Reg. 36,-552 (1986). During the course of the hearing, the AU heard 33 witnesses and received 95 exhibits into evidence.⁴ On May 22, 1986, the AU issued a comprehensive opinion finding that MDMA fit none of the three criteria prerequisite to placement in Schedule I. Relying on the hearing testimony of experts in the health care community, the AU concluded that MDMA had an accepted medical use for treatment in the United States, 21 U.S.C. § 812(b)(1)(B), and an accepted safety for use under medical supervision, 21 U.S.C. § 812(b)(1)(C). The AU also found that the record did not establish that MDMA had a "high" potential for abuse. 21 U.S.C. § 812(b)(1)(A). The AU therefore recommended that MDMA be placed into Schedule III of the CSA.4On July 1, 1985, while the hearing was proceeding, the Administrator placed MDMA into Schedule I of the Controlled Substances Act pursuant to the emergency scheduling provisions of the Act, 21 U.S.C. § 811(h)(1). 50 Fed. Reg. 23,118 (1985). The Administrator determined that this action was necessary to avoid an imminent hazard to the public safety. Id.

The Administrator, however, declined to accept the reasoning and scheduling recommendation of the AU. In his October 13, 1986, decision, the Administrator held that the phrases "currently accepted medical use in treatment in the United States" and "accepted safety for use ... under medical supervision" as used in the CSA, 21 U.S.C. § 812(b)(1), both mean that the FDA has evaluated the substance for safety and approved it for interstate marketing in the United States pursuant to the Federal Food, Drug, and Cosmetic Act of 1938 ("FDCA"), 21 U.S.C. § 355. From these premises, the Administrator reasoned that because the FDA has not approved a new drug application ("NDA") or investigational new drug application ("IND") authorizing interstate marketing of MDMA under the FDCA, MDMA cannot be lawfully marketed and has neither a currently accepted medical use in treatment in the United States nor an accepted safety for use under medical supervision. Finally, the Administrator found that the DEA had sustained its burden of proving that MDMA has a high potential for abuse. The Administrator's final rule, effective November 13, 1986, placed MDMA into Schedule I. Dr. Grinspoon appeals from this final rule under the CSA, 21 U.S.C. § 877.

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Chevron-deference analysis and statutory interpretation arguments from Part II.B-E omitted.]_

F. Conclusion.

For the reasons listed above, we conclude that the Administrator erroneously applied an interpretation of the "accepted medical use in treatment in the United States" and "accepted safety for use ... under medical supervision" criteria of section 812(b)(1) that directly conflicts with congressional intent. We therefore vacate the Administrator's determination that MDMA should be placed in Schedule I of the CSA and remand the rule for further consideration by the DEA. On remand, the Administrator will not be permitted to treat the absence of FDA interstate marketing approval as conclusive evidence that MDMA has no currently accepted medical use and lacks accepted safety for use under medical supervision.

Petitioner Grinspoon has offered his own theory concerning the type of inquiry the Administrator must make under the statute. He urges us to adopt a standard for the second and third criteria that is based upon the opinion of members of the medical community. He contends that Congress drafted the CSA with this type of standard in mind. To support this contention, Grin-spoon cites the testimony of two representatives of the Bureau of Narcotics and Dangerous Drugs ("BNDD"), DEA's predecessor agency, during legislative consideration of Pub.L. No. 91-513, the Comprehensive Drug Abuse Prevention and Control Act of 1970. Michael R. Sonnenreich, Deputy Chief Counsel of the BNDD, testified that drugs in Schedule I would "have no medical use as determined by the medical community," and that "the medical community" would decide "whether or not the drug has [a] medical use____" Hearings on Drug Abuse Control Amendments Before *892 the Subcomm. on Public Health and Welfare of the House Comm, on Interstate and Foreign Commerce, 91st Cong., 2d Sess. 696, 718 (1970) ("House Hearings"). Likewise, John Ingersoll, Director of the BNDD, testified that substances placed in Schedule I would be those drugs that "the medical profession has already determined to have no legitimate medical use in the United States." House Hearings at 678.

While we acknowledge that the statements by the BNDD witnesses before the House Subcommittee tend to support Dr. Grinspoon's position, we do not believe they are entitled to much weight as indicia of congressional intent in fashioning the "accepted medical use" and "accepted safety for use ... under medical supervision" criteria. See McCaughn v. Hershey Chocolate Co., 283 U.S. 488, 493-94, 51 S.Ct. 510, 512, 75 L.Ed. 1183 (1931) ("statements ... made to committees of Congress ... are without weight in the interpretation of a statute"). This is especially true where, as here, there is no indication whatsoever in either the legislative history or the history of any subsequent amendments that Congress concurred with the views expressed by the witnesses. In short, we do not find Grinspoon's evidence to be persuasive on the issue of affirmative congressional intent to have certain members of the medical community determine whether a substance has an "accepted medical use in treatment in the United States" or "accepted safety for use ... under medical supervision.".

The nature of our review further constrains us from requiring the Administrator to adopt Dr. Grinspoon's proposed construction of section 812(b)(1). Although we find that the Administrator's present interpretation of the second and third Schedule I criteria contravenes congressional intent, we are unable to ascertain with any certainty what Congress intended to be the proper interpretation of subsections (B) and (C). In other words, while we are satisfied that Congress intended to preclude reliance on the absence of FDA approval in assessing whether a substance has an "accepted medical use" and "accepted safety for use ... under medical supervision," we have found nothing to indicate how Congress affirmatively intended these two ambiguous statutory phrases to be construed and applied. It appears to us that Congress has implicitly delegated to the Administrator the authority to interpret these portions of the CSA, and we must therefore refrain from imposing our own statutory interpretation upon the agency. Chevron, 467 U.S. at 843, 104 S.Ct. at 2781. Hence, to avoid unduly infringing upon the Administrator's legitimate discretion to develop a legally acceptable standard — i.e., one that does not conflict with the intentions of Congress, and makes sense in light of the statutory language, the legislative history, and the purposes of the entire legislative scheme— we remand the rule to the Administrator for reconsideration and for further proceedings not inconsistent with this opinion.

III. Challenges Based on "Arbitrary and Capricious" Standard.

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.

A. "High" Potential For Abuse.

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. § 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.

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*893 Subsection

on MDMA's "high" potential for abuse omitted.]_

B. Impact Of Scheduling On Research.

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. § 1301.42(a)-(c); mandatory special registration with the DEA, 21 C.F.R. §§ 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.

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 *897 MDMA have available avenues by which to pursue such research." Id.

Second, and more importantly, Dr. Grin-spoon 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. § 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.

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Subsection on DEA's reliance on HHS evaluation omitted.]_

For the foregoing reasons, the rule is vacated and remanded to the Administrator for further proceedings consistent with this opinion.