Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing

January 31, 2009

Hyman, Phelps & McNamara P.C. has posted an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing”. This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein, provides a comprehensive overview of how the federal health care program antikickback law, the Federal False Claims Act, and other federal and state laws affect pharmaceutical marketing activities. The outline focuses on the major problem areas for drug marketing under these laws, and, for each area, describes the pertinent safe harbors, OIG advisory opinions, and major enforcement actions. The outline also provides general guidelines for evaluating marketing proposals.

This outline was first published by Hyman, Phelps & McNamara in 1996, and has been updated periodically. The new version is current as of January 31, 2009. Although the primary focus is on marketing of pharmaceuticals, much of the outline is equally applicable to the marketing of medical devices, and the major government actions against device companies are discussed.