The U.S. Supreme Court case Abbott Laboratories et al. v. Gardner, Secretary of Health, Education, and Welfare et al., 1966 revolved around the question of whether drug manufacturers could challenge a regulation issued by the Commissioner of Food and Drugs requiring all prescription drugs to be labeled with their generic names in addition to their brand names before enforcement actions were taken against them for non-compliance. The court ruled that pre-enforcement review was permissible under the Administrative Procedure Act (APA), which allows parties aggrieved by agency action to seek judicial review thereof unless statutes preclude such relief or if agency action is committed to agency discretion by law. The court found that neither exception applied in this case; thus, it held that the plaintiffs had standing to sue because they faced a dilemma between costly compliance with uncertain regulations and risking serious criminal and civil penalties for noncompliance.

In the dissenting opinion for Abbott Laboratories v. Gardner, Justice Harlan argued that the majority's decision to allow pre-enforcement review of federal regulations was a departure from traditional judicial restraint and could lead to an overwhelming number of premature lawsuits. He contended that courts should not intervene in administrative matters until specific enforcement actions have been initiated by agencies, as this would ensure concrete legal issues were at stake rather than hypothetical ones. Furthermore, he expressed concern about the potential burden on courts and agencies if they had to deal with challenges before rules were enforced or even finalized. In his view, allowing such early intervention undermined both efficient administration and respect for agency expertise.