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AMERICAN PHARM. ASSN. v. WEINBERGER

June 6, 1974

AMERICAN PHARMACEUTICAL ASSOCIATION et al., Plaintiffs,
v.
Caspar W. WEINBERGER et al., Defendants


John H. Pratt, District Judge.


The opinion of the court was delivered by: PRATT

JOHN H. PRATT, District Judge.

 This is an action for judicial review of a regulation of the Food and Drug Administration (FDA) which restricts the distribution of methadone to certain specified outlets as set forth in the regulation. In effect, it prohibits virtually all licensed pharmacies from dispensing this drug when lawfully prescribed by a physician, despite the fact that methadone was invented and was first used as a safe, useful and effective agent in the treatment of severe pain and for antitussive purposes. Decision is not made easier by the fact that in recent years methadone has become a widely known maintenance agent in the treatment of heroin addicts and there is evidence of serious abuses in the distribution of this drug. In their efforts to control improper distribution of methadone, there are strong public policy arguments on the side of defendants. At the same time, the popularity of methadone for use as a pain killer has declined because of the introduction of effective new drugs, and as recently as 1972 the plaintiff Association formally recommended that FDA withdraw its approval of methadone for its indications as an analgesic and antitussive and expressed its philosophic non-disagreement with a course of regulation which would restrict the distribution and use of methadone to approved methadone treatment programs.

 The challenged regulation, while ruling out most so-called community pharmacies in the dispensing of methadone for any purpose, still permits approved hospital pharmacies to dispense methadone for analgesic and antitussive purposes. Stripped of the rhetoric which abounds in the papers before us, this appears to be the basis of plaintiffs' complaint. Whether the FDA has the authority to enact the challenged regulation depends on the interplay and connection between two complementary but distinct statutes, the Food, Drug and Cosmetic Act of 1938 and the Comprehensive Drug Abuse Prevention & Control Act of 1970 and the respective roles assigned by Congress to the agencies which administer these Acts. With this brief background, we proceed to the issues presented.

 This cause came on for hearing on defendants' motion to dismiss, or in the alternative, for summary judgment and plaintiffs' cross-motion for summary judgment on May 8, 1974. Plaintiffs challenge the validity of certain provisions of the Food and Drug Administration's methadone regulations, 21 C.F.R. § 130.44 ("Conditions for use of methadone") and § 130.48 ("Drugs that are subjects of approved new-drug applications and that require special studies, records and reports.") *fn1" Specifically, plaintiffs object to those parts of the regulations which purport to restrict the distribution of methadone to direct shipments from the manufacturer to (a) approved maintenance treatment programs, (b) approved hospital pharmacies, and (c) in cases where hospital pharmacies are unavailable in a particular area, to selected community pharmacies. *fn2"

 Plaintiffs include the American Pharmaceutical Association (APhA), a professional association of pharmacists with a membership in excess of 50,000, three individual professional pharmacists and an individual physician. They argue that the restrictions imposed on the channels of distribution exceed the limits of FDA's authority, were promulgated on the basis of an inadequate record and, being discriminatory in several respects, violate the due process clause of the Fifth Amendment. Plaintiffs seek declaratory relief holding said restrictions invalid and enjoining defendants from enforcing them.

 Defendants are the Secretary of Health, Education and Welfare, the Commissioner of Food and Drugs, the Attorney General and the Acting Administrator of the Drug Enforcement Administration. They counter plaintiffs' contentions by citing FDA's authority under the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 301 et seq., to control access to the public market of all new drugs (21 U.S.C. § 335) and to promulgate regulations for the efficient enforcement of the Act (21 U.S.C. § 371(a)) and their authority under the Comprehensive Drug Abuse Prevention & Control Act of 1970 (Pub.L. 91-513, 84 Stat. 1241) "[to] determine the appropriate methods of professional practice in the medical treatment of . . . narcotic addicts. . . ." (42 U.S.C. § 257a) *fn3" With respect to plaintiffs' contention that the regulations in question constitute arbitrary and capricious action not supported by the administrative record, defendants note what they argue is "ample evidence" to support the regulation's restrictions on methadone distribution. See defendants' Memorandum in Opposition to Plaintiffs' Motion for Summary Judgment, pp. 22-29. Finally, in answering plaintiffs' due process challenge, defendants urge that they need only demonstrate a rational basis for the regulations in order to satisfy the Constitution and that the classifications in issue are unquestionably rationally based in the purposes of the enabling statute. Since the Court concludes that the regulation exceeds the limits of FDA's statutory authority insofar as it purports to restrict the channels of distribution for a drug which is not deemed solely investigational, the Court need not address plaintiffs' latter two arguments.

 I.

 The drug methadone, a synthetic substitute for morphine, is a "new" drug within the meaning of section 201(p) of the Federal, Food, Drug and Cosmetic Act, 21 U.S.C. § 321(p) and, as a new drug, requires FDA's approval of a NDA, filed with the Commissioner of Food and Drugs *fn4" pursuant to section 505(b) of the Act, 21 U.S.C. § 355(b). The drug was first approved by FDA in the 1950's as safe for use as an analgesic and antitussive agent as well as for short-term detoxification of persons addicted to heroin. Subsequently, investigation of methadone for use in long-term maintenance of narcotic addicts (methadone maintenance) was approved by FDA pursuant to its authority under 21 U.S.C. § 355(i), the investigational new-drug (IND) exemption. Section 355(i) of the Act empowers FDA to exempt from NDA approval requirements those new drugs "intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs." Final guidelines for long-term maintenance programs were promulgated by FDA in 1971. 36 Fed.Reg. 6075 (1971). A year later FDA determined that "retention of the drug [methadone] solely on an investigational status appears to be no longer warranted" (37 Fed.Reg. 6940) and published a notice of proposed rulemaking which resulted, with certain modifications, in the regulations now in question.

 The final regulation gave notice that pursuant to FDA's authority under 21 U.S.C. § 355(c), the Commissioner was withdrawing approval of all outstanding NDA's because of "a lack of substantial evidence that methadone is safe and effective for detoxification, analgesia, or antitussive use under the conditions of use that presently exist." *fn5" 37 Fed.Reg. 26794 (1972). Having withdrawn all approved NDA's, the Commission's new regulatory scheme is presently the exclusive means of distribution for the drug methadone. The Commissioner has thereby created an admittedly unique classification for methadone since on the one hand he has determined that methadone should not be limited solely to investigational status while at the same time concluding that the drug is inappropriate for regular NDA approval. As statutory support for this novel solution to the methadone dilemma, defendants rely on an expansive interpretation of the Commissioner's NDA authority under § 355 of the Act.

 II.

 One of the six enumerated grounds for refusing approval of a new drug application (NDA) specifically deals with the "methods" or "controls" used in connection with the proffered ...


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