• Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
  • March 17, 2004
  • Law Firm: Covington & Burling - Washington Office
  • The president signed into law today the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the "Act"), which included significant amendments to the statutory provisions governing the process for generic drug approvals. These amendments to the Hatch-Waxman Act affect the availability of 30-month stays, 180-day exclusivity, and several other aspects of the generic drug approval process. Each provision is summarized in turn below.