Volume 102 - Issue 4 Georgetown Law Journal

The FDA’s Plan B Fiasco: Lessons for Administrative Law

Administrative law—the law governing the decisions of administrative agencies—is a complex field, but its basic rules are pretty simple: Do not act arbitrarily. Do not consider factors that the law makes irrelevant. Do not cover up the truth. Do not cave in to illegitimate political demands.

When an administrative agency follows these rules, it can usually expect a positive reception from the courts. When it does not, it may feel a chill. And when an agency breaks all of these rules at once—arbitrarily departing from prior practice without a reason, introducing irrelevancies, concealing the truth, and giving in to political meddling—it can expect not only an icy judicial reaction, but also, if the issue is important enough, an existential crisis within the ranks of the agency itself.

So it was with the U.S. Food and Drug Administration (FDA)’s long running bungling over emergency contraception. For more than a decade, the FDA 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 entire period, and because the FDA did not want to admit it, the agency resorted to extreme measures to avoid confronting the truth. With every new stratagem, the FDA dug itself deeper into an administrative law hole: inventing policies on the fly, grasping at tangents, shrouding the truth, and cowering before illegitimate political demands.

 

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