Writing for the Court, Justice John Marshall Harlan II reversed the Third Circuit Court of Appeals’ ruling and held that the drug manufacturers’ challenge to the FDA’s “established name” regulation was ripe for judicial review. Harlan began by clarifying that the basic rationale of the ripeness doctrine is to prevent courts from entangling themselves in abstract disagreements over administrative policies and to protect agencies from judicial interference until a decision has been formalized and its effects felt in a concrete way. Harlan established a two-part test for evaluating ripeness, explaining that courts must evaluate both the “fitness of the issues for judicial decision” and the “hardship to the parties of withholding court consideration.”

Regarding the fitness of the issues, Harlan found that the dispute was a purely legal question of statutory construction since the Court was asked to determine if the Commissioner had properly interpreted the statute to require the generic name of a drug to appear every time the trade name was used. Harlan noted that the regulation represented a “final agency action” and because the issue was legal in nature and didn't require further factual development, it was appropriate for immediate judicial review.

Harlan then addressed the hardship prong, arguing that the impact of the regulation on the manufacturers was sufficiently “direct and immediate.” He explained that the regulation put the companies in a dilemma where they either had to comply and incur the significant costs of changing all their labels and promotional materials or follow their present course and risk serious criminal and civil penalties for “misbranding” drugs. Ultimately, the Court held that the controversy was ripe and the manufacturers weren’t required to wait for an actual prosecution to challenge the law.