## Facts

- The Federal Food, Drug, and Cosmetic Act (FDCA) bars marketing a “new drug” without prior FDA approval.
- Generix Drug Corporation manufactured and distributed generic versions of previously approved brand-name drugs.
- Generix’s products contained the same active ingredients as approved drugs but used different inactive ingredients (excipients) such as binders, fillers, and coloring agents.
- The United States alleged the FDA had not approved new drug applications for the specific finished generic products Generix distributed.
- The Government asserted that each finished drug product (active and inactive ingredients together) is a “drug” and may be a “new drug” unless generally recognized as safe and effective or otherwise outside the statutory definition.
- The district court found a reasonable possibility that differences in excipients could affect safety and effectiveness and enjoined distribution of specified products.
- The court of appeals vacated the injunction and held that a product with the same active ingredients as an approved drug is not subject to the FDCA “new drug” prohibition regardless of excipient differences.

## Issues

1. Whether the FDCA term “drug” refers to the finished drug product as marketed (including excipients) or only to active ingredients.
2. Whether a generic finished dosage form with the same active ingredients as an approved drug, but different excipients, is a “new drug” requiring prior FDA approval.

## Decision

- The Supreme Court unanimously reversed the court of appeals.
- The Court held that the statutory definition of “drug” is broad enough to include entire finished drug products, including active and inactive ingredients.
- The Court held that a generic drug product is a “new drug,” subject to premarket approval, until the product itself (not merely its active ingredients) no longer falls within the FDCA’s “new drug” definition.
- The Court rejected the view that prior approval of a pioneer drug’s active ingredients automatically permits marketing of generic formulations with different excipients without FDA approval.

## Legal Principles

- Under the FDCA, “drug” encompasses the finished product as marketed, not only the pharmacologically active component.
- A finished generic product may be a “new drug” unless that product is generally recognized as safe and effective, or otherwise satisfies the statutory criteria removing it from “new drug” status.
- Differences in excipients can be material to safety and effectiveness; FDA authority extends to evaluating the full formulation.

## Conclusion

The Court confirmed that the FDCA’s premarket approval requirement can apply to generic drugs as finished products, and that approval of a brand-name drug’s active ingredient does not, by itself, authorize distribution of generic formulations containing different excipients.


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