title: Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Mello
authors.forename: David M
authors.initials: DM
authors.lastname: Studdert
mesh_terms: D004334:Drug Administration Schedule; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D040541:Marketing / Q000379:methods* / Q000706:statistics & numerical data; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D004364:Pharmaceutical Preparations; D012189:Retrospective Studies; D014481:United States; D035642:Whistleblowing
chemical_list: D004364:Pharmaceutical Preparations