Many articles focus solely on the new features of the most recent government settlement. An April 5, 2011 article entitled, "Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints", however, sheds light on exactly what kind of alleged off-label practices by pharmaceutical companies resulted in government intervention and large settlements between 1996 and 2010. By systematically dividing the purpose of various companies’ off-label campaigns into three different areas, the article found that 85% of the alleged off-label promotion was for unapproved diseases, 54% was for unapproved disease sub-types, and 34% was for an unapproved dosing strategy. The marketing practices which subjected companies to fines and scrutiny can also be broken down into four different strategies (e.g. prescriber, company, payer and consumer-related practices. ) After classifying the practices within the complaints in this manner, it was found that all of the complaints alleged that the off-label promotion involved some prescriber-related practices (including self-serving presentations of literature, free samples, direct financial incentives, and teaching and research activities). Ninety percent of the complaints mentioned company practices, such as unrealistic sales quotas; 56% concerned payer-related strategies; while 44% included some consumer-related practices.
Not only is the breakdown of these whistleblower complaints fascinating, the report’s findings highlight those trends and marketing areas, which expose pharmaceutical companies to the greatest risk. Although its lessons are most apparent to those companies that disregard and/or flagrantly breach the law, they should also be useful to those companies that strive to be compliant. For instance, the report found that 71% of the whistleblowers were sales representatives, 20% were sales and accounting managers, and 9% were unaffiliated physicians. As a result, companies should ensure that their compliance programs include clear and identifiable ways for representatives, managers and outside physicians to report instances of off-label promotion. Hopefully, if these avenues are well-publicized, individuals would alert the company to the illegal promotion before they resort to other remedies. The report also indicated that off-label marketing practices directed to physicians were omnipresent in the sample group, and sales representatives routinely reviewed confidential medical files for potential customers. This demonstrates that every company must implement policies and procedures regarding their interactions with healthcare professionals. Ideally, these guides should identify appropriate and inappropriate behavior, and would specifically prohibit any practice where company representatives receive or review confidential patient information. Lastly, the analysis showed that some companies had policies and procedures, but they were either un-enforced or in some cases, purposefully ignored. This finding suggests that audits are a key component of any working compliance program. In conclusion, by identifying the business areas and practices which are subject to heightened scrutiny and will ultimately become the fodder for future prosecutions, the analysis tells companies what areas and practices they need to carefully monitor to avoid prosecution.