Off-Label Promotion in the US: Protecting Your Company and Employees

摘要

We all saw the headlines and were perhaps stunned, not only by the dollar amount of the settlement, but also by the extent of the corrective actions mandated in the agreement. While the Pfizer settlement is the largest to date, it is but the latest in a string of other settlements with manufacturers in the US involving off-label promotion.Evidenced by these settlements, the government is signalling that it intends to continue enforcing the laws governing the activities of:large pharmaceutical companies - "Eli Lilly in dollar1.4B Zyprexa settlement: Pharmaceutical company agrees to settle suits over questionable marketing of drug for off-label uses";small companies - "Jazz Pharma to pay dollar20M to settle Orphan Medical misbranding charge"; and medical device companies - "Endoscopic Technologies to Pay U.S. dollar1.4 Million to Resolve Allegations of Medicare Fraud".