The Impact of the Fraud and Abuse Laws on Pharmaceutical Advertising and Marketing Compliance: A Manufacturer's Perspective
Leslie Restaino, General Counsel, Validus Pharmaceuticals, USA
The intersection between the health care fraud and abuse laws and pharmaceutical marketing practices in the U.S. raises interesting compliance issues for pharmaceutical manufacturers, particularly in light of the newly enacted federal health care reform legislation. The legislation includes significant anti-fraud measures as well as additional funding to fight fraud and abuse. Such increased scrutiny on pharmaceutical promotional practices requires manufacturers to pay close attention to and comply with the heath care laws, regulations and guidelines. Compliance is the only clear path to minimizing exposure to potential liability.
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