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Regulation of Pharmaceutical Promotion in the Twenty-First Century

This article outlines how the authors believe the drug promotion regulatory system should be redesigned to provide physicians, other health professionals, and consumers with truthful and balanced information in the new century. Basic legal and regulatory concepts underlying the current regulatory framework and “cultural” changes that pose new challenges for regulators are highlighted. An innovative framework for pharmaceutical promotion regulation is proposed. This framework includes the FDA focusing on using technology to identify materials that are likely to be harmful to the public; using quality control processes in review; and making judgments based more on scientific information about how people receive and use information. The system must be based on the proven principles that have evolved over the years but also be flexible enough to deal with a new world in which information and technology are the hallmarks of a new medical system.