Reckitt & Colman, Ltd. v. Administrator, Drug Enforcement Admin., No. 85-1193

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtBefore ROBINSON, Chief Judge, and MIKVA and SILBERMAN; SILBERMAN
Citation788 F.2d 22
PartiesRECKITT & COLMAN, LTD., Petitioner, v. ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION, Respondent. McNeil Pharmaceutical, Intervenor.
Decision Date08 April 1986
Docket NumberNo. 85-1193

Page 22

788 F.2d 22
252 U.S.App.D.C. 120
RECKITT & COLMAN, LTD., Petitioner,
v.
ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION, Respondent.
McNeil Pharmaceutical, Intervenor.
No. 85-1193.
United States Court of Appeals,
District of Columbia Circuit.
Argued Feb. 12, 1986.
Decided April 8, 1986.
As Amended April 8, 1986.

Page 23

Petition for Review of an Order of Drug Enforcement administration.

Thomas O. Henteleff, Washington, D.C., with whom Peter R. Mathers, Washington, D.C., was on brief for petitioner.

Gary Schneider, Atty., Dept. of Justice, with whom Stephen E. Stone, Associate Chief Counsel, Dept. of Justice, and Charles E. Pazar, Sr. Atty., Drug Enforcement Administration, Washington, D.C., were on brief for respondent.

Robert A. Dormer, with whom Robert T. Angarola, Washington, D.C., was on brief for intervenor.

Before ROBINSON, Chief Judge, and MIKVA and SILBERMAN, Circuit Judges.

Opinion for the Court filed by Circuit Judge SILBERMAN.

SILBERMAN, Circuit Judge:

This is a petition for review of an order of the Administrator of the Drug Enforcement Agency maintaining the classification of the drug buprenorphine as a narcotic under the Controlled Substances Act, 21 U.S.C. Secs. 801-966 (1982). The petitioner, Reckitt & Colman, Ltd., complains that the DEA Administrator's designation of buprenorphine as a narcotic rests on an improper determination that buprenorphine is a derivative of the opiate drug thebaine. Because we conclude that the Administrator's definition of the statutory term "derivative" represents a permissible construction of the Act, and that substantial record evidence supports the Administrator's conclusion that buprenorphine falls within this definition, we affirm the Administrator's decision.

I.

The Controlled Substances Act is a comprehensive regulatory measure that divides the universe of hazardous drugs into different schedules subject to varying degrees of control. See 21 U.S.C. Sec. 812 (1982). The Act also designates certain substances as "narcotic drugs." See id. Sec. 802(16). In general, the severity of restrictions imposed on the marketing of controlled drugs depends more on what schedule a drug is placed in than on whether it is designated a narcotic. Classification as a narcotic, however, does circumscribe the manner and extent of a drug's importation and exportation, see id. Secs. 952-53, and its use in drug detoxification programs, see id. Sec. 823(g). Moreover, criminal penalties for violations of the Act are harsher if a narcotic substance

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is involved. See id. Sec. 841(b)(1). And, in practical terms, the DEA's classification of a drug as a narcotic may be expected to impair a drug manufacturer's marketing freedom.

Under the Act, any "derivative" of opium or an opiate is classified as a narcotic drug. 1 Buprenorphine is a relatively new drug, produced from the opium constituent thebaine, that has been developed for medical use as a pain reliever. Although buprenorphine is marketed in many foreign countries, Reckitt & Colman has attempted to introduce it into the United States only recently. In May 1982, the Department of Health and Human Services notified the DEA Administrator that a new drug application for buprenorphine had been approved. HHS recommended that the DEA Administrator modify buprenorphine's status as a Schedule II controlled substance under the Act to the less restricted status of Schedule V. HHS also recommended, however, that buprenorphine continue to be classified as a narcotic drug on the ground that it is a thebaine derivative.

In September 1982, the Administrator issued a notice of proposed rulemaking indicating that buprenorphine would be transferred to Schedule V but would retain its classification as a narcotic. 47 Fed.Reg. 41,401 (1982). Reckitt & Colman objected, urging that buprenorphine should be entirely decontrolled and that it should not be designated a narcotic. The matter was set for an on-the-record hearing before an administrative law judge. In October 1984, the ALJ issued an opinion essentially agreeing with Reckitt & Colman's position. The DEA Administrator, however, rejected the ALJ's conclusions and issued a final order placing buprenorphine in Schedule V and retaining its designation as a narcotic. 50 Fed.Reg. 8104 (1985). Although Reckitt & Colman has abandoned its objection to the placement of buprenorphine in Schedule V, it challenges that part of the Administrator's order maintaining buprenorphine's narcotic classification. This court has jurisdiction pursuant to 21 U.S.C. Sec. 877 (1982). 2

II.

Reckitt & Colman contends that in maintaining buprenorphine's narcotic classification, the DEA Administrator adopted an unprecedented and improper definition of the statutory term "derivative." To be sure, this is a fairly unusual case. In the course of the administrative proceedings, it became apparent that the derivative status of a substance is a more complicated and uncertain matter than previously thought by the agency. Buprenorphine had heretofore been considered a derivative of thebaine simply because it is prepared from thebaine. Under modern technological methods, however, it is possible to prepare aspirin, acetaminophen (Tylenol), and, apparently, even water from thebaine. Thus, a more refined (and restrictive) definition of "derivative" was obviously needed. But neither the Act nor its legislative history purport to define what a derivative is. Under these circumstances, the Administrator indicated that the agency would regard as a derivative of a drug any substance (1) prepared from that drug, (2) which chemically resembles that drug, and (3) which

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has some of the adverse effects of that drug. See 50 Fed.Reg. 8104, 8107 (1985). The Administrator then concluded, "Buprenorphine possesses sufficient opiate-like actions and does so resemble the structure of its parent, thebaine, that it must be considered to be a derivative thereof...." Id.

Reckitt & Colman argues that the Administrator's construction of the Act is flawed because it defines the term "derivative" too broadly. In the petitioner's view, a substance may rightly be regarded as a derivative of another only if it can be produced from it in only one or two chemical operations. (Buprenorphine is produced from thebaine in six or seven steps). The Administrator rejected this narrow "two-step" definition. He felt that "[t]o attribute great significance to the actual...

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6 practice notes
  • John Doe, Inc. v. Drug Enforcement Admin., No. 06-1270.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 27 Abril 2007
    ...Labs., Inc. v. DEA, 54 F.3d 450, 451 (7th Cir.1995); Nutt v. DEA, 916 F.2d 202, 203 (5th Cir. 1990); Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 23 (D.C.Cir.1986). And, in the one instance where a court of appeals has directly (albeit summarily) addressed the scope of 21 U.S.C. § 877......
  • Novelty, Inc. v. D.E.A., No. 08-1296.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 22 Junio 2009
    ...factfinder is entitled to ascribe different significance to the deficiencies of Novelty's records. Cf. Reckitt & Colman, Ltd. v. Adm'r, 788 F.2d 22, 26-27 (D.C.Cir.1986). Accordingly, I reject Novelty's sufficiency challenge to the evidence supporting the DA's deficient record keeping findi......
  • Local Union 1395, Intern. Broth. of Elec. Workers, AFL-CIO v. N.L.R.B., AFL-CI
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 8 Agosto 1986
    ...The agency remained free to substitute its own view of the evidence for that of the ALJ, see Reckitt & Colman, Ltd. v. Administrator, DEA, 788 F.2d 22, 26 (D.C.Cir.1986), and cases cited therein; and this court must respect the Board's findings of fact if supported by substantial evidence. ......
  • Morall v. Drug Enforcement Admin., No. 04-1367.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 24 Junio 2005
    ...to be ascribed to them `depends largely on the importance of credibility in the particular case.'" Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 26-27 (D.C.Cir. 1986) (quoting Universal Camera Corp., 340 U.S. at 496-97, 71 S.Ct. 456). Obviously, credibility is central to the Deputy Adm......
  • Request a trial to view additional results
5 cases
  • John Doe, Inc. v. Drug Enforcement Admin., No. 06-1270.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 27 Abril 2007
    ...Labs., Inc. v. DEA, 54 F.3d 450, 451 (7th Cir.1995); Nutt v. DEA, 916 F.2d 202, 203 (5th Cir. 1990); Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 23 (D.C.Cir.1986). And, in the one instance where a court of appeals has directly (albeit summarily) addressed the scope of 21 U.S.C. § 877......
  • Novelty, Inc. v. D.E.A., No. 08-1296.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 22 Junio 2009
    ...factfinder is entitled to ascribe different significance to the deficiencies of Novelty's records. Cf. Reckitt & Colman, Ltd. v. Adm'r, 788 F.2d 22, 26-27 (D.C.Cir.1986). Accordingly, I reject Novelty's sufficiency challenge to the evidence supporting the DA's deficient record keeping findi......
  • Local Union 1395, Intern. Broth. of Elec. Workers, AFL-CIO v. N.L.R.B., AFL-CI
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 8 Agosto 1986
    ...The agency remained free to substitute its own view of the evidence for that of the ALJ, see Reckitt & Colman, Ltd. v. Administrator, DEA, 788 F.2d 22, 26 (D.C.Cir.1986), and cases cited therein; and this court must respect the Board's findings of fact if supported by substantial evidence. ......
  • Morall v. Drug Enforcement Admin., No. 04-1367.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 24 Junio 2005
    ...to be ascribed to them `depends largely on the importance of credibility in the particular case.'" Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 26-27 (D.C.Cir. 1986) (quoting Universal Camera Corp., 340 U.S. at 496-97, 71 S.Ct. 456). Obviously, credibility is central to the Deputy Adm......
  • Request a trial to view additional results

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