Recently I spoke at the annual meeting of the Food and Drug Law Institute (FDLI) on Eagle v. Azar, which is currently on appeal to the D.C. Circuit. At first blush the case seems of limited importance, because Eagle Pharmaceuticals is simply challenging FDA’s interpretation of statutory language that has since been amended. But reading through the litigation papers reveals a more interesting disagreement between the parties, about what a court should consider, when assessing whether a statute clearly answers a particular legal question. I will unpack this after the jump. Warning: this is more of an essay than a blog post. I start with a TL;DR.Continue reading “Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue”
FDA Law SSRN Reading List – October and November (Part 2 of 2)
Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.
Continue reading “FDA Law SSRN Reading List – October and November (Part 2 of 2)”