Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”

Recent court decisions, including Federal Circuit’s ruling in GlaxoSmithKline v. Teva, threaten the FDA’s “skinny labeling” pathway by exposing generic manufacturers to patent liability based on required labeling. Congress should act to reverse these decision to preserve skinny labeling as a pathway to facilitate the timely entry of affordable generic drugs.