Prescription Drug Advertising and Promotion: Learnings from Recent Food and Drug Administration Warning Letters

Abstract

The Food and Drug Administration (FDA) has regulatory authority over advertising and promotion for prescription drug products in the United States. Professionals in the pharmaceutical industry can learn from FDA's enforcement efforts against violative activities. Thirty warning letters (WLs) issued by FDA's Division of Drug Marketing, Advertising, and Communication for violative advertising and promotion from January 2001 through June 2005 were analyzed for themes and trends. The findings are consistent with messages FDA has conveyed at recent public meetings. In particular, a clear theme was insufficient prominence of risk information and other information needed to appropriately balance claims. The WLs provide contemporary examples of FDA's operational interpretation of the requirements for prescription drug advertising to be truthful, fair, balanced, and not misleading. The WLs underscore FDA's concerns with violative promotional practices that may have public health implications.