Can a party seek judicial review of FDA regulations before they are enforced, and is such a challenge ripe for court consideration?

Abbott Laboratories and other pharmaceutical companies challenged FDA regulations requiring prominent display of a drug's 'established name' alongside its proprietary name on labels and printed materials. These regulations were implemented under the 1962 amendments to the Federal Food, Drug, and Cosmetic Act. The drug manufacturers contended that the Commissioner had overstepped his statutory authority in issuing these regulations.

The government, in response, argued that pre-enforcement review was not permissible and that the case was not yet ripe for judicial review. This dispute centered on the scope of the FDA's regulatory power and the timing of judicial intervention in administrative rulemaking processes.

The drug manufacturers initiated the case by filing a declaratory judgment action in district court. The district court ruled in favor of the manufacturers, granting both declaratory and injunctive relief. However, the Court of Appeals for the Third Circuit reversed this decision, determining that pre-enforcement review was not authorized and that no actual case or controversy existed. Due to the significance of the issue and an apparent conflict with a Second Circuit decision, the Supreme Court granted certiorari to review the case.

(Harlan, J.)

Yes. Pre-enforcement judicial review of FDA regulations is permissible, and such challenges are ripe for court consideration. The Federal Food, Drug, and Cosmetic Act contains no evidence of congressional intent to preclude judicial review. A flexible interpretation of finality applies, considering the regulations as 'final agency action' under the Administrative Procedure Act. The impact of the regulations on affected parties is sufficiently direct and immediate to render the issue appropriate for judicial review. A strong presumption in favor of judicial review exists absent clear and convincing evidence of contrary legislative intent. This presumption aligns with fundamental principles of administrative law, ensuring agencies remain accountable and that regulated entities have recourse before facing potential enforcement actions. The ripeness doctrine does not bar pre-enforcement review in this context, as waiting for actual enforcement could impose significant hardships on regulated parties. The regulations in question represent the consummation of the agency's decision-making process and create legal obligations with immediate practical effects. Denying pre-enforcement review would force regulated entities to choose between complying with potentially invalid regulations at great expense or risking severe penalties for non-compliance. Such a dilemma is precisely what pre-enforcement review is designed to prevent. The legal rights and obligations established by the regulations are sufficiently concrete to warrant judicial examination at this stage. This approach to ripeness and reviewability ensures meaningful judicial oversight of agency actions while respecting the need for efficient administrative processes.