Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
PLoS Med. 2011 Apr;8(4):e1000431. doi: 10.1371/journal.pmed.1000431. Epub 2011 Apr 5.
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.
尽管受到监管限制，药品的标签外推广在美国仍很常见。然而，标签外推广的范围仍未得到很好的描述。我们为构成标签外推广的策略和实践制定了一个分类法。
我们获得了美国联邦欺诈案件中针对制药公司的未密封举报人投诉，其中包含标签外推广的指控（1996 年 1 月至 2010 年 10 月），并对其进行了结构化审查。我们根据举报人报告，对每个标签外营销计划的战略目标以及用于实现这些目标的实践进行了编码和分析。我们确定了我们分析样本中的 18 个独特案例中的 41 份投诉（导致 79 亿美元的追回）。投诉中描述的标签外营销计划有三个非互斥的目标：扩展到未经批准的疾病（35/41，85％）、未经批准的疾病亚型（22/41，54％）和未经批准的药物剂量（14/41，34％）。制造商据称使用四种非互斥的营销实践来追求这些目标：与处方者相关（41/41，100％）、与业务相关（37/41，90％）、与支付方相关（23/41，56％）和与消费者相关（18/41，44％）。与处方者相关的实践是公司策略的核心，包括对文献的自我服务呈现（31/41，76％）、免费样品（8/41，20％）、直接向医生提供财务激励（35/41，85％）、教学（22/41，54％）和研究活动（8/41，20％）。
标签外营销实践似乎扩展到医疗保健系统的许多领域。不幸的是，最常见的被指控的标签外营销实践似乎也是最难通过外部监管手段控制的。
