For years, the received wisdom in biopharmaceutical industry compliance has maintained that medical affairs departments within companies must be independent — or firewalled — from their more overtly commercially oriented counterparts in sales and marketing.
No law or regulation expressly requires such independence, which is often referred to as separation. Rather, separation has been adopted by many companies in the industry as a way to mitigate risks arising out of the Federal Food, Drug, and Cosmetic Act and the Anti-Kickback Statute.
Separation is believed to help assure the legitimacy of activities that various authorities have regarded as suspect, such as manufacturer dissemination of information about off-label uses, and financial support for research or physician education.
Law360
Reexamining Biopharma Medical-Commercial Separation
October 24, 2022
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