Photo of Bexis

We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).Continue Reading A Couple of Thoughts about the Comstock Act

Photo of Bexis

This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.

First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly