Decoy Indication: New Hybrid Method for Off Label Promotion of Medications?

A recent article published by the Public Library of Science Medicine (PLoS Medicine), has highlighted new innovative ways in which pharmaceutical companies are promoting medications for off-label use.

Specifically, the article sets forth that a new practice referred to as “decoy indication” occurs where “a company may seek approval for just a narrow indication in order to speed a drug to market … In other words, a drug may be approved for [a] very narrow ‘decoy indication’ while an extensive off-label campaign is not disclosed to drug regulators.”

Additionally, the article highlights the extent in which pharmaceutical companies are turning to Medical and Graduate education programs as venues to promote off-label uses. According to the article and as expressed in a recent Parke-Davis business plan, “Medical education drives this market!”

The article concludes by setting forth that “pharmaceutical marketing has distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.”