Hatch-Waxman at 40

At the heart of U.S. drug price reduction policy is a law that is about to turn 40 years old: the Hatch-Waxman Act (HWA). The HWA, signed in September 1984, attempts to balance lower prices through generic competition with innovation incentives to brands. The law does so by lowering barriers to entry for generics and by granting various new exclusivities to the brands. The exclusivities give branded manufacturers 5-year data exclusivity for new chemical entities (NCEs) and 3-year exclusivity for NCE extensions or modifications that are supported by clinical data.

A variety of ideas have been advanced to limit anti-competitive conduct. On September 19, the Center on Health Policy at Brookings will convene an event to examine the origins of the Act, lessons learned from the first 40 years, and considerations for the future of regulation of markets for generic drugs and competition in the pharmaceutical industry. 

Zuckerman Spaeder partner Bill Schultz will be moderating the first panel.