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A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships with Specialty Pharmacies: Part II

April 07, 2017

By Gary F. Giampetruzzi, Jonathan Stevens

The manufacturer/specialty pharmacy relationship and attendant risks should be on the agenda of every compliance officer in the life sciences industry. Specialty pharmacies are uniquely positioned to connect manufacturers, prescribers, and patients. In Part I of this two-part series, we covered the wide-ranging role of specialty pharmacies in the dispensing of specialty drugs, and the increased risks of government scrutiny and enforcement around them. The risk areas potentially implicated by these relationships include inappropriate inducements, off-label promotion, switching/interference with clinical decisions, underreporting of adverse events or product quality complaints, misuse, overuse, and privacy. These risks warrant a tailored compliance program directed at specialty pharmacy activities, as we will now cover in Part II of this series.

This article was originally published in Bloomberg Law.

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Image: Gary F. Giampetruzzi
Gary F. Giampetruzzi
Partner, Litigation Department