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.

Leslie Gladstone Restaino, . has a broad range of experience with the legal and regulatory issues involved in the pharmaceutical/biotechnology, and medical device industries and their complex product, device and services offerings.  Leslie has particular expertise in the areas of business/corporate law, pharmaceutical, medical device, and healthcare law, FDA regulatory matters, complex licensing and strategic alliances, commercial contracts, pharmaceutical operations and commercialization, and patents and intellectual property.  She is currently the General Counsel of Validus Pharmaceuticals LLC, a specialty pharmaceutical company focusing in the psychiatry and neurology markets.

Validus Pharmaceuticals LLC is focused on acquiring, reformulating and marketing prescription products relevant to the psychiatry and neurology markets.  Validus seeks to acquire mature products that have well defined and accepted clinical utility relevant to today’s practice of medicine.