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Compliance, Commercial Risk, and Pfizer: Lessons LearnedThe recent announcement of Pfizer’s record $2.3 billion settlement for off-label marketing and its felony plea agreement "for misbranding Bextra with the intent to defraud or mislead" should refocus industry’s attention on compliance risks for commercial activities. While the size of the fine reflects Pfizer’s recidivism (their fourth settlement for illegal marketing practices since 2002), the settlement is in line with enforcement trends. A close look at this and other recent high-profile cases offers important guidance for other industry players to heed.
While Pfizer’s subsidiary, Pharmacia & Upjohn Company Inc. pled guilty to off-label marketing charges, Pfizer’s civil settlement covered allegations of false claims and anti-kickback violations. Their new corporate integrity agreement ("CIA") deals with a range of commercial activities: promotional material and practices, speaker programs, consulting engagements, sponsorship of clinical research, market research, authorship of publications, and other activities with compliance implications. It provides insight into the list of hotspots on which OIG can be expected to concentrate.
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