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FDA Regulation of Prescription Drug Advertising

Carl C. Peck, MD; Peter H. Rheinstein, MD, JD, MS
JAMA. 1990;264(18):2424-2425. doi:10.1001/jama.1990.03450180088035.
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Dr Kessler and Mr Pines1 present a thoughtful and balanced review of the Food and Drug Administration's (FDA) regulation of prescription drug promotion. In their conclusion, the authors call to mind issues where the need for change is clear and other issues that have long vexed the agency. Mr Pines, a former FDA Associate Commissioner for Public Affairs, is intimately familiar with these issues and has chaired conferences on them in several forums. Many of the presentations from these conferences have been published.2,3

The article makes some cogent observations. The need to revise the brief summary for use in advertising in a way that makes it readable and more useful is inescapable. The need for governmental oversight of promotional activities involving gifts and other financial inducements to health care providers, such as travel, was made clear in hearings conducted by Sen Edward Kennedy of Massachusetts as early as


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