PHARMACEUTICAL MFRS. v. FOOD & DRUG ADMIN.

Civ. A. No. 77-291.

484 F.Supp. 1179 (1980)

PHARMACEUTICAL 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.

United States District Court, D. Delaware.

February 11, 1980.


Attorney(s) appearing for the Case

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...

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