Where there is no explicit statutory preclusion of, and no persuasive reason, to conclude Congress intended to preclude pre-enforcement review, and the controversy is ripe for adjudication.
Petitioners appealed a judgment, which dismissed their complaint that challenged regulations issued by the Commissioner of Food and Drugs. Petitioners argued that the Commissioner had exceeded his authority under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.S. § 301 et seq., by requiring labels, advertisements, and other printed matter to designate the established name of a drug every time its trade name was used. The dismissal was based on a holding that pre-enforcement review of rules was precluded by the Act, and because no case or controversy existed and no relief was available under the Administrative Procedure Act or the Declaratory Judgment Act.
Did the Circuit Court err in dismissing Petitioner's complaint?
Injunctive and declaratory judgment remedies are discretionary, and courts traditionally have been reluctant to apply them to administrative determinations unless these arise in the context of a controversy "ripe" for judicial resolution. The basic rationale of the ripeness doctrine 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 of ripeness of a controversy is best seen in a twofold aspect, requiring a court to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.