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The Federal Food, Drug, and Cosmetic Act of 1938 is a federal law designed to ensure that food, drugs, and cosmetics are safe for consumers. Congress delegated authority to the Food and Drug Administration (FDA) to carry out the act.
In the 1960s, Congress amended the act to allow for the imposition of labeling requirements on drug manufacturers. In response, the commissioner of the FDA issued a new regulation that required drug manufacturers to print drugs’ generic names on all labels and advertisements alongside the drugs’ brand names. The purpose of this regulation was to alert doctors and patients that generic drugs might be available as inexpensive alternatives to brand-name drugs.
In the case of Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), thirty-seven drug manufacturers sued the commissioner. The drug companies argued that the FDA commissioner had exceeded his authority in issuing the regulation.
The United States Supreme Court ultimately took up the case. The central issue was whether an agency regulation is ripe for judicial review before the agency has attempted enforcement. The divided Court ultimately held that pre-enforcement review of the regulation was appropriate.
The Court’s discussion of the doctrine of ripeness is especially educational for its discussion of the two-part inquiry courts must use to determine whether a case is ripe for judicial review.