Cite as: 520 U. S. 725 (1997)
Opinion of the Court
tory authority to impose the new labeling requirement; the FDA countered that the claim was not ripe for judicial review for want of any proceedings to enforce the regulation.
The Court dealt with ripeness under a two-pronged test:
"Without undertaking to survey the intricacies of the ripeness doctrine it is fair to say that its basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties. The problem is best seen in a twofold aspect, requiring us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." 387 U. S., at 148-149 (footnote omitted).
Under the "fitness for review" prong, we first noted that the FDA's adoption of the labeling regulation was "final agency action" within the meaning of § 10 of the APA, 5 U. S. C. § 704, and then rejected the Government's argument that review must await enforcement. 387 U. S., at 149-152. We reasoned that "the impact of the regulations upon the petitioners is sufficiently direct and immediate as to render the issue appropriate for judicial review at this stage" because promulgation of the regulations "puts petitioners in a dilemma": "Either they must comply with the [labeling] requirement and incur the costs of changing over their promotional material and labeling or they must follow their present course and risk prosecution." Id., at 152 (internal quotation marks omitted). Similarly, the immediate impact of the regulation on the manufacturers satisfied the "hardship" prong: "Where the legal issue presented is fit for judicial resolution, and where a regulation requires an immediate and significant change in the plaintiffs' conduct of their affairs with serious
743
Page: Index Previous 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 NextLast modified: October 4, 2007