Grinspoon v. Drug Enforcement Admin.

• Decision Date: 03 March 1987
• Docket Number: No. 86-2007,86-2007
• Citation: 828 F.2d 881
• Parties: Lester GRINSPOON, M.D., Petitioner, v. DRUG ENFORCEMENT ADMINISTRATION, Respondent. . Heard
• Court: U.S. Court of Appeals — First Circuit

Page 881

828 F.2d 881

Lester GRINSPOON, M.D., Petitioner, v. DRUG ENFORCEMENT ADMINISTRATION, Respondent.

No. 86-2007.

United States Court of Appeals First Circuit.

Heard March 3, 1987.

Decided Sept. 18, 1987.

Richard Cotton, Washington, D.C., for petitioner.

Harry S. Harbin, Washington, D.C., with whom William F. Weld, Asst. Atty. Gen., Criminal Div., Boston, Mass., Charles S. Sapho, Chief, Narcotic and Dangerous Drug Section, Dennis F. Hoffman, Chief Counsel, Drug Enforcement Admin., Stephen E. Stone, Associate Chief Counsel, Drug Enforcement Admin., Washington, D.C., and Charlotte A. Johnson, were on brief, for respondent.

Before COFFIN and TORRUELLA, Circuit Judges, and PETTINE, ^* Senior District Judge.

COFFIN, Circuit Judge.

On November 13, 1986, the Administrator of the Drug Enforcement Administration ("DEA") issued a final rule placing the substance 3,4-methylenedioxymethamphetamine ("MDMA") into Schedule I of the Controlled Substances Act ("CSA"), 21 U.S.C. Secs. 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,

(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. Sec. 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 for "accepted safety for use ... under medical supervision" in 21 U.S.C. Sec. 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 case 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. Grinspoon'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-Methylenedioxymethamphetamine (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 analysis ³ and concurring in the recommendation that MDMA be placed into Schedule I.

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 and requests for a hearing, the Administrator referred the matter to an Administrative Law Judge ("ALJ") 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 ALJ heard 33 witnesses and received 95 exhibits into evidence. ⁴ On May 22, 1986, the ALJ 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 ALJ concluded that MDMA had an accepted medical use for treatment in the United States, 21 U.S.C. Sec. 812(b)(1)(B), and an accepted safety for use under medical supervision, 21 U.S.C. Sec. 812(b)(1)(C). The ALJ also found that the record did not establish that MDMA had a "high" potential for abuse. 21 U.S.C. Sec. 812(b)(1)(A). The ALJ therefore recommended that MDMA be placed into Schedule III of the CSA.

The Administrator, however, declined to accept the reasoning and scheduling recommendation of the ALJ. 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. Sec. 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. Sec. 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. Sec. 877.

II. Accepted Medical Use And Safety Under The CSA.

We turn first to petitioner's claim that the Administrator erred in interpreting the phrases "accepted medical use in treatment in the United States" and "accepted safety for use ... under medical supervision" in section 812(b)(1) to mean, in essence, "approved for interstate marketing by the FDA under the FDCA." Before embarking on an analysis of that issue, however, we begin by explaining the appropriate standard of review in a case, such as this, where a court must assess an agency's interpretation of a statute it administers.

A. Standard of Review.

The Administrator argues correctly that we must review his interpretation of the CSA in light of the guidelines set forth by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). In Chevron the Court explained that a reviewing court must employ a two-step analysis that focuses initially on the intentions of Congress:

First, always, is the question whether Congress had directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.

Id. at 842-43, 104 S.Ct. at 2781 (emphasis supplied). In the absence of congressional intent, however, the court must proceed to a second inquiry If ... the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.

Id. at 843, 104 S.Ct. at 2781-82 (footnote omitted; emphasis supplied).

It is undisputed that Congress has not directly spoken to the question at issue here, namely, the proper means of interpreting the second and third criteria of section 812(b)(1). The absence of express intent, however, does not compel us to proceed to the deferential second step of the Chevron scheme. As the Supreme Court indicated in a footnote to its Chevron opinion, "[i]f a court, employing traditional tools of statutory construction, ascertains that Congress had an intention on the precise question at issue, that intention is law and must be given effect." Id. at 843 n. 9, 104 S.Ct. at 2781 n. 9. Recently the Supreme Court has reaffirmed this proposition,...