Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process

Aug 1999 – Article
Food and Drug Law Journal, Vol. 54, Number 2 (1999), pages 187-194

There is a paucity of legislative history on the Hatch-Waxman Act.[2] This article will try to provide a general overview of the legislative process and some insight into the Act's underlying assumptions, with the help of some graphics. With a bill as hard-fought as Hatch-Waxman, there was much written about it after the fact, but not a great deal of coherent legislative history. The article also provides a timetable to compare the drug discovery and development, patent protection, and generic competition processes that the Act affects.