Pharmaceutical Mfrs. v. Food & Drug Admin.

Decision Date11 February 1980
Docket NumberCiv. A. No. 77-291.
PartiesPHARMACEUTICAL MANUFACTURERS ASSOCIATION, Plaintiff, The American College of Obstetricians and Gynecologists; National Association of Chain Drug Stores, Inc.; American Society of Internal Medicine; Private Medical Care Foundation, Inc., a corporation; Congress of County Medical Societies, Inc., a corporation; Pottawatomie County Medical Society, Inc., a corporation; Oklahoma State Medical Association; and Francis A. Davis, M. D., Plaintiffs-Intervenors, v. FOOD AND DRUG ADMINISTRATION; Joseph A. Califano, Jr., Secretary of Health, Education and Welfare; and Donald Kennedy, Commissioner of Food and Drug Administration, Defendants, Consumers Union of United States, Inc.; Consumer Federation of America; National Women's Health Network; and Women's Equity Action League, Defendants-Intervenors.
CourtU.S. District Court — District of Delaware

COPYRIGHT MATERIAL OMITTED

Richard L. Sutton, Morris, Nichols, Arsht & Tunnell, Wilmington, Del., Joel E. Hoffman, and Anthony L. Young, Wald, Harkrader & Ross, Washington, D. C., Bruce J. Brennan, and Edwin C. Mulcahy, Jr., Washington, D. C., Howard P. Hoeper, Vedder, Price, Kaufman & Kammholz, Chicago, Ill., Thomas D. Quinn, Jr., Reasoner, Davis & Vinson, Washington, D. C., Carl Roberts, Associate Gen. Counsel, American Pharmaceutical Association, Washington, D. C., for plaintiff Pharmaceutical Manufacturers Association, plaintiffs-intervenors The American College of Obstetricians and Gynecologists and The National Association of Chain Drug Stores, Inc., and American Pharmaceutical Association, amicus curiae.

Mason E. Turner, Jr., Prickett, Sanders, Jones, Elliott & Kristol, Wilmington, Del., Don G. Holladay and A. P. Murrah, Jr., Andrews, Davis, Legg, Bixler, Milsten & Murrah, Inc., Oklahoma City, Okl., for plaintiffs-intervenors Private Medical Care Foundation Inc., Congress of County Medical Societies, Pottawatomie County Medical Society, Inc., Oklahoma State Medical Association, and Francis A. Davis, M.D.

James W. Garvin, Jr., U. S. Atty., John X. Denney, Jr., Asst. U. S. Atty., Wilmington, Del., Raymond W. Philipps, Consumer Affairs Section, Antitrust Div., Dept. of Justice, Washington, D. C., Richard M. Cooper, and Michael P. Peskoe, Food and Drug Administration, Dept. of Health, Education and Welfare, Rockville, Md., for defendants.

Aida Waserstein, Bader, Dorsey & Kreshtool, Wilmington, Del., and Mary C. Boudart, Wilmington, Del., Marcia D. Greenberger, and Margaret A. Kohn, Women's Rights Project, Center for Law and Social Policy, Washington, D. C., for defendants-intervenors Consumers Union of the United States, Inc., Consumer Federation of America, National Women's Health Network, and Women's Equity Action League.

OPINION

STAPLETON, District Judge:

In this case, plaintiffs, the Pharmaceutical Manufacturers Association, the American College of Obstetricians and Gynecologists, the National Association of Chain Drug Stores, Inc., Private Medical Care Foundation, and others challenge the validity of a regulation promulgated by the Food and Drug Administration which requires certain information to be provided to patients for whom drugs containing estrogens are prescribed. The defendant agency has been joined by the Consumers Union of the United States, Inc., the Consumer Federation of America, the National Women's Health Network, and Women's Equity Action League (intervenor-defendants). The case is before me now on the parties' cross-motions for summary judgment.

The regulation in question, codified in 21 C.F.R. § 310.515, is one of only four regulations which require patient labeling to be dispensed with a prescription drug.1 The regulation was proposed on September 29, 1976, with a notice of proposed rulemaking published in the Federal Register (41 Fed. Reg. 43108) permitting sixty days for comments. The regulation as proposed and as promulgated outlined several categories of information which must be included in a patient package insert, and required that such an insert be provided to a patient every time the drug was dispensed or administered (i. e., injected).2 Thus, physicians as well as pharmacists are required to provide the labeling when they act as dispensers of the medication.

The agency's action came a a result of several studies published in 1975 which indicated an association between the use of conjugated estrogens and an increased risk of endometrial cancer in women. The FDA convened its Obstetrics and Gynecology Advisory Committee to review the studies, and that Committee proposed changes in the physician labeling provided by manufacturers of estrogen.3 Following the Committee's work, Joint Congressional hearings were conducted on January 21, 1976 to look into the matter of postmenopausal use of estrogens.4 Among the witnesses were a panel of physicians who testified as to the association between estrogens and endometrial cancer, government representatives from both FDA and the National Institutes of Health and representatives of the pharmaceutical firm which manufactures the largest selling conjugated estrogen.

Following these hearings, the FDA published the proposed estrogen regulation for comments. The final rule, published July 22, 1977, was accompanied by a lengthy preamble (42 Fed.Reg. 37636) which attempted to deal with the comments the agency had received and to explain the purpose and effect of the rule. Also published along with the proposed regulation was a sample label which included all the information required by the regulation. 42 Fed.Reg. 37645 (July 22, 1977). The effective date of the regulation was to be September 20, 1977. Plaintiffs promptly filed this suit, however, and requested that the agency stay the effective date of the regulation pending the outcome of the suit. Consideration of the stay petition tolled the running of the sixty day period, making the effective date October 18, 1977. On October 5, 1977, I denied plaintiffs' motion for a preliminary injunction. Opinion of October 5, 1977. These motions for summary judgment followed.

Plaintiffs and plaintiff-intervenors raise a number of challenges to the regulation. First, they contend that the FDA lacks statutory authority to require patient packaging inserts for prescription drugs. They next assert that such a requirement is an unconstitutional interference with the practice of medicine. Finally, they challenge the adequacy of the FDA's findings and conclusions embodied in the preamble to the regulation and argue that, based on the administrative record, the regulation is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," 5 U.S.C. § 706(2)(A) (1976). Because I find that the FDA does have statutory authority to require patient labeling, that such a requirement does not interfere with any constitutionally protected rights of physicians, that the agency's reasoning is sufficiently articulated and that the record adequately supports its judgment, I will grant the defendants' motion for summary judgment and deny that of the plaintiffs.

I. THE STATUTORY BASIS OF THE REGULATION.

The Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C. § 301 et seq., vests broad substantive rulemaking authority in the Secretary of Health, Education and Welfare. Section 701(a) of the Act, 21 U.S.C. § 371(a), grants to the Secretary the "authority to promulgate regulations for the efficient enforcement of this chapter." It is clear that this section authorizes the Secretary to promulgate binding, substantive regulations; the Secretary is not limited in his or her rulemaking to "interpretive" regulations or statements of policy. Weinberger v. Hynson, Westcott and Dunning, 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir. 1975). This authority of the Secretary has been delegated to the Commissioner of the FDA who promulgated the regulation here challenged.5

The primary objective of the Federal Food, Drug and Cosmetic Act is the protection of the public health. United States v. An Article of Drug, Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969). As such, its rulemaking authority under Section 701(a) has been broadly construed to uphold a wide variety of assertions of regulatory power. As Judge Gurfein of the Second Circuit Court of Appeals wrote in United States v. Nova Scotia Foods Products, 568 F.2d 240 (2d Cir. 1977):

We read Section 701(a) as analogous to the provision "make . . . such rules and regulations as may be necessary to carry out the provisions of this Act," in which case "the validity of a regulation promulgated thereunder will be sustained so long as it is `reasonably related to the purposes of the enabling legislation.'" Mourning v. Family Publications Services, Inc., 411 U.S. 356, 369, 93 S.Ct. 1652, 1660, 36 L.Ed.2d 318 (1973). When agency rulemaking serves the purposes of the statute, courts should refuse to adopt a narrow construction of the enabling legislation which would undercut the agency's authority to promulgate such rules.

568 F.2d at 246.

At the same time, the broad language of Section 701(a) does not give the FDA unlimited regulatory powers; regulations issued under that section must effectuate a Congressional objective expressed elsewhere in the Act. In the instant case, the agency maintains that it has promulgated the challenged regulation pursuant to Section 701(a) in order to effectuate the objectives reflected in Sections 502(a) and 505(d) of the Act, 21 U.S.C. §§ 352(a) and 355(d).

A. Section 502.

Section 502 reads in pertinent part:

A drug or device shall be deemed to be misbranded—
(a) If its labeling is false or misleading in any particular.
* * * * * *
(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or
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