The Off-Label Nightmare: What Happens When the Feds Come A’Calling

Posted 01 May 2008 | By

The phone rings; it's the CEO. You've been head of regulatory affairs at Drug Company X for three weeks, hired from a consulting firm to evaluate the corporation's culture of compliance. It's been a whirlwind, learning to manage the worldwide regulatory affairs of a company with hundreds of drugs grossing billions in revenues, in an era when the industry feels like it has a Department of Justice bull's-eye on its back. Your sales force alone is in the tens of thousands; the structure and fragmentation of reporting are stunning. Multiple fiefdoms-teams calling on physicians, hospitals, nursing homes, managedcare companies-all vie for control of sales and a share of the bonus loot. You've been charged with reining them in, keeping their worst impulses in check, but not stopping their impressive sales abilities. After all, this is a forprofit business and, without sales, you and all the rest of the folks are out of work. At times, you have wondered, am I really just like the rider on the back of a monster bull: hardly in control, mainly just along for the ride; hoping it'll last long enough for me to make some good money but still be in one piece when it's time to retire? "I need you right now" says the CEO.

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