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Tri-Bio Laboratories Inc. v. United States

submitted: August 19, 1987.


Appeal from the United States District Court for the Middle District of Pennsylvania, D.C. Civil No. 86-0083.

Gibbons, Chief Judge, and Weis, Circuit Judge, and Kelly,*fn* District Judge.

Author: Weis


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 Gentaject, a veterinary pharmaceutical product recommended for use in one day old chicks to prevent early mortality caused by three species of bacteria.*fn1 Gentaject, a generic drug,*fn2 contains the same ingredients as a previously approved product manufactured by the Schering Corporation of Kenilworth, New Jersey and currently marketed under the brand name "Garasol."

Garasol was patented in 1963 and approved for commercial distribution by the FDA in 1978. The patent expired in 1980. A year later, plaintiff sought FDA approval to market its generic copy of Garasol under the brand name Gentaject. As required by statute the FDA regulations, plaintiff filed a new animal drug application (NADA) to demonstrate that its product was safe and effective for its intended use. However, instead of including the extensive test data ordinarily required in new applications, the plaintiff's application merely referred the FDA to Schering's test data in support of the original Garasol application. Because of the plaintiff's failure to submit original safety and effectiveness data, the FDA rejected the application as incomplete.

In October 1982 plaintiff renewed its request for FDA approval, asserting that Gentaject was not a "new drug" requiring the usual panoply of testing. Plaintiff equated its request to a remarketing of a previously FDA-approved drug (Garasol) under a new label (Gentaject). Plaintiff contended that Gentaject, as the bioequivalent*fn3 of Garasol, in essence already had received FDA approval. But the FDA reaffirmed its denial of the plaintiff's request, citing longstanding agency policy that all new animal drug applications "must stand or fall on the basis of the submitted data."

After some preliminary, inconclusive legal skirmishing, plaintiff agreed to file a citizen's petition*fn4 with the FDA, requesting the agency to declare that Gentaject was not a new animal drug and, thus, did not require a full application. In the petition plaintiff asserted that Gentaject was not a "new drug" within the meaning of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360b(a)(1), because the drug formulation -- marketed under the Garasol label -- was generally recognized as safe and effective for its intended use by experts qualified to make such judgments.

The Commissioner denied the citizen's petition. The agency concluded that Gentaject was a new animal drug within the meaning of the Act and that it had not become generally recognized as safe and effective.

Plaintiff then brought this action, asking the district court to declare that Gentaject was not a new drug, to direct the FDA to approve its application by incorporating Schering's data, or to reconsider the citizen's petition using the data previously submitted by Schering. Alternatively, plaintiff urged that the FDA approve Gentaject based on agency in-house research -- conducted in defense of the litigation -- through which it had found Gentaject in fact safe and effective for its intended use. The parties filed cross-motions for summary judgment.

The district court granted the FDA's motion and entered judgment against plaintiff. The court concluded that the FDA properly interpreted its statutory authority in formulating the policy of rejecting applicants which depended on data submitted by previous applicants. The court further determined that the FDA's rejection of the citizen's petition was not arbitrary, capricious, an abuse of discretion, or otherwise no in accordance with law.

On appeal plaintiff argues that the FDA's approach is unreasonable because it compels expensive and indefensible duplicative testing of drugs already approved for commercial marketing. Plaintiff also asserts that the FDA did not adequately analyze all the submitted evidence, a review which plaintiff contends would have revealed that Gentaject was not a "new drug". In the absence of a proper factual hearing by the agency, plaintiff maintains that the district court should have examined the issue de novo.

The FDA responds that plaintiff failed to present the requisite safety and effectiveness data for its product and that, without such evidence, the Food, Drug and Cosmetic Act mandates rejection of the plaintiff's application.


The federal government began premarketing regulation of pharmaceuticals with the Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § § 301-92). After passage of the 1938 Act, FDA approval was necessary before marketing any drug not generally recognized as safe by the scientific community. The Act assumes that a new drug is adulterated and ...

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