Tri-Bio Laboratories, Inc. v. United States of America and Food and Drug Administration

OPINION OF THE COURT

WEIS, Circuit Judge.

A pharmaceutical manufacturer filed for Food and Drug Administration approval of a generic animal drug, incorporating in its application the research and testing data submitted by another manufacturer that earlier had obtained approval to market the predecessor brand name drug. Because of its policy treating such data as proprietary and confidential, the FDA refused to consider the previously filed material. The district court sustained the agency action and entered summary judgment against the generic manufacturer. We will affirm.

Plaintiff manufactures…