International Regulatory Enforcement (PHIRE)

On the Heels of Significant FCPA Settlements, Past & Present Meet: Novartis Reaches FCA Settlements

July 17, 2020

Gary F. Giampetruzzi , Jane H. Yoon , Sandra González & Michael Mottweiler

Government resolutions with pharmaceutical companies from the early 2000s involving expensive meals and speaker honoraria provided to healthcare professionals ("HCPs") helped reshape the way the industry considered and approached transfers of value to HCPs. More recently, government investigations and resolutions have focused on whether and how manufacturers are transferring value to patients through donations to charitable copay foundations and patient support programs. Past and present have converged in Novartis' most recent settlements out of the Southern District of New York and District of Massachusetts, reminding life sciences companies, already wisely focusing on new(er) risk areas, to devote resources and attention to traditional risk areas, especially as these traditional activities migrate to new platforms in the present COVID-19 environment.

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