The United States Supreme Court case, UNITED STATES v. GENERIX DRUG CORP., et al., 1982 revolved around the interpretation of a provision in the Federal Food, Drug and Cosmetic Act (FDCA). The FDCA required that all "new drugs" must be approved by the FDA before they can be marketed. Generix Drug Corp was accused of selling unapproved generic versions of brand-name drugs without obtaining necessary approval from FDA. The company argued that their products were not "new drugs" but rather just generic equivalents to already approved ones and thus did not require separate approval. However, the court ruled against Generix stating that under FDCA any drug product differing from a pioneer drug cannot be considered as generally recognized among experts as safe and effective for its labeled uses until it has been tested through clinical trials and certified by FDA's new-drug application process.

In the dissenting opinion for United States v. Generix Drug Corp., it was argued that the majority's interpretation of "drug" in the Federal Food, Drug, and Cosmetic Act (FDCA) was too narrow. The dissent believed that this restrictive definition could potentially allow manufacturers to evade regulations by making minor changes to their products' formulas or ingredients. They contended that a broader interpretation of "drug," which would include any substance intended for use in diagnosing, curing, mitigating, treating or preventing disease regardless of slight alterations in composition from an approved drug product should be adopted instead. This wider understanding would better serve public health interests by ensuring all substances marketed with therapeutic claims are subject to FDA scrutiny before reaching consumers.