[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
June 27, 2017

Pharmaceutical Marketing for Rare Diseases: Regulating Drug Company Promotion in an Era of Unprecedented Advertisement

Author Affiliations
  • 1Myeloma Service, Division of Hematologic Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
  • 2Knight Cancer Institute, Division of Hematology Oncology, Oregon Health & Science University, Portland
  • 3Department of Public Health and Preventive Medicine and Center for Health Care Ethics, Oregon Health & Science University, Portland
JAMA. 2017;317(24):2479-2480. doi:10.1001/jama.2017.5784

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.