Crackdown on 'Off-label' Pitches

In a major shift of enforcement strategy, the U.S. Department of Justice (DOJ) has firmly taken control of the enforcement against pharmaceutical, biotechnology and medical-device manufacturers. Both "Main Justice" in Washington and various U.S. attorney offices around the country now enforce against these companies through the Food, Drug and Cosmetic Act (FDCA), the Anti-Kickback Statute and the False Claims Act. The DOJ has signaled—via its most recent settlements over the course of two months—how its enforcement will change the way companies promote and market therapeutic products in the future.


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