The US Food and Drug Administration (FDA) draws a distinction between direct-to-consumer advertising of specific drug products, which it regulates, and advertisements intended to create disease awareness, which it does not. Other nations, including the United Kingdom and the Netherlands, that ban direct-to-consumer marketing permit disease awareness efforts. Challenges arise when disease awareness efforts are made for conditions for which only 1 approved drug product is available; in this case, awareness will boost the sales of a specific drug, and several nations, include the United States, selectively regulate this type of advertising. Recently, a novel form of disease awareness promotion, through a daytime soap opera, raised questions about the role and regulation of this form of marketing.
Mailankody S, Prasad V. Pharmaceutical Marketing for Rare Diseases: Regulating Drug Company Promotion in an Era of Unprecedented Advertisement. JAMA. 2017;317(24):2479–2480. doi:10.1001/jama.2017.5784
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