Committee Serial No. 32. Considers legislation to eliminate anticompetitive practices in the patenting, licensing, and marketing of drugs, and to require FDA standardization of drug names and stricter safety and efficacy standards for new drugs.

Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.

This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.

Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?