Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?

Yale J Health Policy Law Ethics. 2015 Summer;15(2):293-347.


In 1984, Congress passed the Hatch-Waxman Act, which catalyzed the creation of the modem generic drug industry. Generic drugs today account for eighty-four percent of all prescriptions dispensed, but less than twenty percent of drug costs. Despite this success, numerous problems in the generic drug market have emerged. Some involve the deliberate manipulation of the Hatch-Waxman system, while others have arisen more unexpectedly, such as the Supreme Court's 2011 decision in Pliva v. Mensing that could undermine consumer confidence in generic drugs. We discuss these emerging challenges and propose updates to the Hatch-Waxman Act to continue support for the timely emergence of safe generic drugs.

Publication types

  • Historical Article
  • Legal Case
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Drug Approval / history
  • Drug Approval / legislation & jurisprudence
  • Drug Industry / legislation & jurisprudence*
  • Drugs, Generic*
  • Drugs, Investigational
  • Government Regulation
  • History, 20th Century
  • History, 21st Century
  • Legislation, Drug* / history
  • Therapeutic Equivalency
  • United States
  • United States Food and Drug Administration


  • Drugs, Generic
  • Drugs, Investigational