Cornell Law Review Volume 93 Issue 5

The FDA and Deference Lost: A Self-Inflicted Would or the Product of a Wounded Agency? A Response to Professor O’Reilly

Professor James T. O’Reilly’s article Losing Deference in the FDA’s Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise is a sweeping critique of the decline of the Food and Drug Administration (FDA), which until recently was considered one of the world’s premier health and safety agencies. According to Professor O’Reilly, the FDA’s decline, resulting in what he contends is the diminishing judicial deference accorded to Agency determinations, is entirely the product of a self-inflicted wound—namely, the Bush Administration’s politicization of the Agency at the expense of science. To drive home his theory, Professor O’Reilly dissects two case illustrations: first, the Agency’s unwarranted denial of approval for the overthe-counter sale to those under eighteen of the drug “Plan B,” a postcoital contraceptive, to appease the Administration’s anti-abortion constituency; and second, the Agency’s complete about-face on its preemption policy, giving drug companies the insulation from tort litigation they have long coveted but could not get from Congress.

 

To read the complete Response, click “VIEW PDF” below. 

:: View PDF