United States v. Generix Drug Corp., 460 U.S. 453 (1983)

United States v. Generix Drug Corp.

No. 81-1222

Argued November 3, 1982
Decided March 22, 1983
460 U.S. 453

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

THE ELEVENTH CIRCUIT

Syllabus

The Federal Food, Drug, and Cosmetic Act (Act) prohibits the marketing of a "new drug" without the prior approval of the Food and Drug Administration (FDA). Section 201(p) of the Act defines a "new drug" as

any drug . . . [which] is not generally recognized . . . as safe and effective . . . or . . . which has not, otherwise than in [safety and effectiveness] investigations, been used to a material extent or for a material time.

Section 201(g)(1) defines the term "drug" as, inter alia, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or in other animals." The Government brought an action in Federal District Court to enjoin respondent Generix Drug Corp. (respondent) from distributing a number of generic drug products containing specified active ingredients, alleging that the FDA had never approved "new drug" applications with respect to such products. Holding that a generic drug product containing the same active ingredients as a previously approved pioneer drug marketed under a brand name is a "new drug" if there is a reasonable possibility that the differences in inactive "excipients" between the generic product and the pioneer drug will make the generic product less safe and effective, and finding that the Government had established a reasonable possibility that the safety and effectiveness of respondent’s generic drug products might be affected by differences between their inactive "excipients" and those found in approved products, the court enjoined respondent from distributing the products in question. The Court of Appeals vacated the injunction and remanded with instructions to dismiss the complaint, holding that the statutory prohibition against the sale of a "new drug" without prior FDA approval does not apply to a drug product having the same active ingredients as a previously approved drug product, regardless of any differences in "excipients."

Held: A generic product is a "drug" within the meaning of the indicated definition in § 201(g)(1). That definition is broad enough to encompass entire drug products, complete with their active and inactive ingredients. Accordingly, a generic drug product is a "new drug," subject to prior FDA approval, until the product (and not merely its active ingredients) no longer falls within the terms of § 201(p). Pp. 457-461.

654 F.2d 1114, reversed.

STEVENS, J., delivered the opinion for a unanimous Court.