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A.L. PHARMA, INC. v. SHALALA

No. 94-5041.

62 F.3d 1484 (1995)

A.L. PHARMA, INC., Appellant, v. Donna E. SHALALA, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided August 25, 1995.

Attorney(s) appearing for the Case

James H. Wallace Jr., with whom James M. Johnstone and Richard L. McConnell Jr., Washington, DC, were on the briefs, argued the cause, for appellant.

Jeffrey B. Chasnow, U.S. Dept. of Justice, with whom Frank W. Hunger, Asst. Atty. Gen., and Catherine L. Copp, Associate Chief Counsel, Food and Drug Admin., Washington, DC, were on the brief, argued the cause, for appellees.

Before EDWARDS, Chief Judge, and BUCKLEY and GINSBURG, Circuit Judges.

BUCKLEY, Circuit Judge:

To gain Food and Drug Administration approval for the sale of a new animal drug, an applicant must demonstrate that it is both safe and effective for its intended uses. Finding that this standard had been met, the FDA approved for sale a drug produced by Philips Roxane, Inc., which is marketed to improve growth and feed efficiency in broiler chickens. Appellant A.L. Pharma, Inc. ("A.L."), a competitor of Philips Roxane, petitioned the FDA to...

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