April 30, 2003

HHS OIG Guidance Raises Concerns About Pharmaceutical Sales and Marketing Practices

Arnold & Porter Advisory

On April 28, 2003, the Office of Inspector General, Department of Health and Human Services ("HHS OIG") released the final version of its Compliance Program Guidance for the Pharmaceutical Industry ("Pharmaceutical Guidance" or "Guidance") 1. The guidance reflects the government's continuing concern about sales and marketing practices by pharmaceutical manufacturers, including manufacturer relationships with physicians, pharmacy benefit managers (PBMs), and others in a position to prescribe or recommend their products. Federal and state health care enforcement agencies have brought a number of high-profile criminal and civil actions against pharmaceutical manufacturers. The release of Guidance signals that investigations of pharmaceutical sales and marketing practices will continue to be a top enforcement priority for the HHS OIG and other health care fraud enforcement agencies.


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