PRE-ENFORCEMENT REVIEW: AN EVALUATION FROM THE PERSPECTIVE OF RIPENESS

• Published in: Virginia environmental law journal 2018-01, Vol.36 (1), p.77-117
• Main Author: Boger, Daniel
• Format: Article
• Language: English
• ISSN: 1045-5183; 1942-9940

The ripeness doctrine prevents federal courts from deciding cases when the injury alleged is too speculative. However, in Abbott Laboratories v. Gardner the Supreme Court held that the ripeness doctrine did not preclude drug companies from mounting a pre-enforcement challenge to a Federal Drug Administration regulation, thereby establishing a presumption in favor of pre-enforcement review of agency regulations. Since then, courts and commentators have often viewed pre-enforcement review favorably, based on its ability to guarantee certainty for regulated parties, check the excesses of the executive branch, and ensure that parties are not subjected to harm at the hands of unlawful agency conduct. This Note uses the policy values underlying the ripeness doctrine to challenge the efficacy of pre-enforcement review. First, because pre-enforcement review involves adjudication of abstract disputes without a concrete set of facts, courts are less likely to reach correct decisions. Second, due to regulatory complexity, courts tend to defer to agencies in pre-enforcement proceedings, giving them inherent advantages. Finally, there is significant evidence demonstrating that pre-enforcement decisions have a prejudicial effect on regulated parties in future enforcement proceedings. These factors combine to significantly damage private litigants’ chances of successfully challenging agency rules at both the pre-enforcement and enforcement stage. For these reasons, use of pre-enforcement review as a means of achieving just outcomes for stakeholders should be reconsidered. By limiting pre-enforcement review of complex agency rules, private parties would actually gain access to higher quality and more meaningful judicial review. Agencies and public interest stakeholders would likewise benefit from the increased efficiency and enforcement ability that would result from limiting judicial review in pre-enforcement settings.