The FDA's Plan B Fiasco: Lessons for Administrative Law
Georgetown University Law Center
September 4, 2013
Georgetown Law Journal, Forthcoming
For well over a decade, the federal Food and Drug Administration scrambled to avoid answering a simple question: can women and girls safely and efficaciously take emergency contraceptives without a health professional’s permission? Because the answer to this question was clear (and affirmative) during this whole period and yet the agency did not want to admit it, the agency resorted to extreme measures to avoid confronting the truth. With every new stratagem, the agency dug itself deeper into an administrative law hole: inventing policies on the fly, grasping at tangents, shrouding the truth, cowering before illegitimate political demands. This article provides the first detailed and up-to-date analysis of how the FDA’s treatment of emergency contraception violated basic tenets of administrative law.
This article also suggests larger lessons for administrative law that might be drawn from this episode. The exposure of the FDA’s misbehavior through interrogatories and depositions in litigation should prompt a softening of the presumption against probing the mental processes of agency decision makers. In addition, the FDA’s political machinations and patent dissembling – and the widespread sense that these were not signs of a healthy administrative agency – should spur reconsideration of judicial and academic support of political interventions in agency decisions and technical covers for those interventions.
Number of Pages in PDF File: 63
Keywords: administrative law, food and drug law, presidential administrationAccepted Paper Series
Date posted: September 5, 2013
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