Off-label marketing of medicines in the US is rife but difficult to control

In their study, the authors classified the strategies and practices used in off-label marketing by examining 41 complaints filed by whistleblowers related to 18 alleged cases of off-label marketing in federal fraud cases that were settled or unsealed between January 2004 and October 2010. These findings provide a snapshot of off-label marketing strategies and practices allegedly employed in the US, and this analysis may help to develop new and effective regulatory strategies.

All of the whistleblowers alleged prescriber-related practices (including providing financial incentives and free samples to physicians), and most alleged internal practices intended to bolster off-label marketing, such as sales quotas that could only be met if the manufacturer's sales representatives promoted off-label drug use. Payer-related practices (for example, discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions) and consumer-related practices (most commonly, the review of confidential patient charts to identify consumers who could be off-label users) were also alleged. However, these practices were alleged by whistleblowers in cases intervened by the US Department of Justice, and were not the subject of testimony in a full trial; thus, some of the practices identified by the researchers could not be confirmed.

The authors say: "Off-label marketing has been ubiquitous in the health care system and features some behaviors and strategies that may be resistant to external regulatory approaches."

They continue: "Aside from sales representatives and other company insiders, who play important roles as whistleblowers, physicians are alone in having a full view of many of the most insidious forms of illegal marketing outlined in the complaints we reviewed. As physicians' understanding of these practices and the consequences of inappropriate off-label promotion for public health evolves, so may their enthusiasm for shutting them down."

More information: Kesselheim AS, Mello MM, Studdert DM (2011) Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints. PLoS Med 8(4): e1000431. doi:10.1371/journal.pmed.1000431

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