Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints

• Published in: PLoS medicine Vol. 8; no. 4; p. e1000431
• Main Authors: Kesselheim, Aaron S, Mello, Michelle M, Studdert, David M
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 01.04.2011; Public Library of Science (PLoS)
• Subjects: Complaints; Drug Administration Schedule; Drug dosages; Drug Industry - legislation & jurisprudence; Drug Labeling - legislation & jurisprudence; Drugs; Evidence-Based Healthcare/Health Services Research and Economics; Humans; Laws, regulations and rules; Marketing; Marketing - methods; Marketing - statistics & numerical data; Off-Label Use - legislation & jurisprudence; Pharmaceutical industry; Pharmaceutical Preparations; Prescription drugs; Public Health and Epidemiology/Health Policy; Retrospective Studies; Sales; Studies; United States; Whistle blowing; Whistleblowing; United States; United States > US; Drug Labeling; Off-Label Use; Drug Administration Schedule; United States; Drug Industry; Humans; Pharmaceutical Preparations; Retrospective Studies; Whistleblowing; Marketing
• ISSN: 1549-1676; 1549-1277; 1549-1676
• DOI: 10.1371/journal.pmed.1000431

Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%). Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.