Schering settlement brings new scrutiny to off-label
Pharma Compliance Alert, October 4, 2006
The recent Schering settlement and CIA are going to bring new scrutiny to pharmaceutical off-label promotions. According to Wayne Pines, president of regulatory services and healthcare at APCO Worldwide, all pharmaceutical companies need to keep abreast of the Schering settlement in order to guide their own dealings with doctors and the government.
"The Schering Plough settlement is another in a series of settlements by the Office of Inspector General," Pines tells Pharma Compliance Alert. "As with many previous settlements, it includes some new dimensions, such as referencing the company's response to an FDA letter as evidence of noncompliance."
The government says it is currently working on more than 150 investigations of pharmaceutical companies involving more 500 or more products.
Pines and David Adams, a partner at Venable law firm will discuss the Schering-Plough settlement, the Dr. Peter Gleason indictment, and the significant impacts they have left on pharmaceutical sales promotions on October 18 during a live audioconference. Go online to learn more.
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