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WARNER-LAMBERT CO. v. HECKLER

Nos. 85-3371, 85-3377 and 85-3383.

787 F.2d 147 (1986)

WARNER-LAMBERT COMPANY, Petitioner, v. Margaret M. HECKLER, Secretary of Health and Human Services, and Frank E. Young, Commissioner of Food and Drugs, Respondents. WILLIAM H. RORER, INC., and Wallace Laboratories, Division of Carter-Wallace, Inc. and Armour Pharmaceutical Company, Petitioners, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, Third Circuit.

Decided April 1, 1986.

Rehearing and Rehearing Denied April 22, 1986.

Attorney(s) appearing for the Case

Charles J. Raubicheck (argued), Davis, Hoxie, Faithfull & Hapgood, New York City (Charles E. Lents, Richard A. Shupack, Morris Plains, N.J., and Arnold B. Dompieri, New York City, of counsel), for petitioner Warner-Lambert Co.

Eugene I. Lambert (argued) and Keith A. Teel, Covington & Burling, Washington, D.C., for petitioners William H. Rorer, Inc., Wallace Laboratories, Division of Carter-Wallace, Inc. and Armour Pharmaceutical Co.

Richard K. Willard, Asst. Atty. Gen., John R. Fleder and Randy S. Chartash, Office of Consumers Litigation Civil Div., U.S. Dept. of Justice, Washington, D.C. (Thomas Scarlett, Chief Counsel, Mary K. Pendergast (argued) and Arthur Y. Tsien, Associate Chief Counsels for Enforcement, Office of General Counsel, Food and Drug Admin., Rockville, Md., of counsel), for respondents.

Before ADAMS, SLOVITER and MANSMANN, Circuit Judges.

Rehearing and Rehearing In Banc Denied in No. 85-3371 April 22, 1986.

OPINION OF THE COURT

SLOVITER, Circuit Judge.

Several novel issues regarding the required showing of efficacy of new drugs are presented in this appeal by four drug manufacturers from the Order of the Commissioner of the Food and Drug Administration (FDA) withdrawing approval for the oral proteolytic enzymes (OPEs) that they manufacture. The Commissioner withdrew

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