December 8, 2003

Hatch-Waxman Reforms Enacted as Part of Medicare Legislation

Arnold & Porter Advisory

President Bush signed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 on December 8, 2003. Title XI of that Act, entitled "Access to Affordable Pharmaceuticals," makes changes in the Hatch-Waxman provisions of the Federal Food, Drug, and Cosmetic Act, provides for Federal Trade Commission and Department of Justice review of certain agreements by pharmaceutical companies, and provides for limited importation of prescription drugs if approved by the Secretary of Health and Human Services. Title XI is available on the Arnold & Porter website at

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