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PHARMACEUTICAL MFRS. ASS'N v. FOOD & DRUG ADMIN.

No. 80-1455.

634 F.2d 106 (1980)

PHARMACEUTICAL MANUFACTURERS ASSOCIATION, a Delaware non-profit membership association, Plaintiff, American College of Obstetricians & Gynecologists; National Association of Chain Drug Stores, Inc.; American Society of Internal Medicine; Private Medical Care Foundation, Inc.; Congress of County Medical Societies, Inc.; The Pottawatomie County Medical Society, Inc.; The Oklahoma State Medical Association; Francis A. Davis, M.D., Intervening Party Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, Joseph A. Califano, Sec. of HEW, Donald Kennedy, Comm. of Foods and Drugs, Defendants, Consumers Union of U. S., Inc., Consumer Federation of America, National Women's Health Network, Women's Equity Action League, Intervening Party Defendants, National Association of Chain Drug Stores, Inc., Plaintiff Intervenor, Appellant.

United States Court of Appeals, Third Circuit.

Decided November 5, 1980.

Attorney(s) appearing for the Case

Joel E. Hoffman (argued), Anthony L. Young, Gloria C. Phares, Wald, Harkrader & Ross, Washington, D. C., Richard L. Sutton, Morris, Nichols, Arsht & Tunnell, Wilmington, Del., Thomas D. Quinn, Jr., Reasoner, Davis & Vinson, Washington, D. C., for National Ass'n of Chain Drug Stores, Inc.

Nancy C. Garrison (argued), Barry Grossman, Sanford M. Litvack, Washington, D. C., Nancy L. Buc, Michael P. Peskoe, Rockville, Md., Peggy L. Ableman, Wilmington, Del., for Food & Drug Administration, et al.

Marcia D. Greenberger, Washington, D. C., (argued), Nancy Duff Campbell, Women's Rights Project Center for Law and Social Policy, Washington, D. C.

Aida Waserstein, Bader, Dorsey & Kreshtoll, Wilmington, D. C., for Consumers Union of U. S., Inc., et al.

Before HUNTER and WEIS, Circuit Judges, and CAHN, District Judge.

OPINION OF THE COURT

PER CURIAM:

In this appeal, the National Association of Chain Drug Stores, Inc. challenges the Food and Drug Administration's authority to promulgate 21 C.F.R. § 310.515 (1980).1 The challenged regulation requires that patient package insert be provided to every patient receiving certain estrogen drugs. In a thorough and well-reasoned opinion, Judge Stapleton...

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