A.L. Pharma, Inc. v. Donna E. Shalala

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 appi’oved 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 reverse its approval and, receiving no satisfaction from the agency, sought relief in the district court. The district court…