Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints
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.
Methods and Findings:
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.
Please see later in the article for the Editors' Summary
Vyšlo v časopise:
Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints. PLoS Med 8(4): e32767. doi:10.1371/journal.pmed.1000431
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1000431
Souhrn
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.
Methods and Findings:
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.
Please see later in the article for the Editors' Summary
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