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Gibbons Directors Contribute to Pharmaceutical and Medical Device Compliance Manual


October 10, 2012

Bruce Levy, a Director in the Criminal Defense Department of Gibbons P.C., and Mara E. Zazzali-Hogan, a Director in the firm’s Business & Commercial Litigation Department, are contributing authors of the recently published Pharmaceutical and Medical Device Compliance Manual, which offers a wide-ranging, in-depth overview of the laws, regulations, and enforcement agencies designed to combat health care fraud, abuse, and waste.

The manual, geared toward compliance officers and health care law attorneys, is a joint project of the Center for Health & Pharmaceutical Law & Policy at Seton Hall University School of Law; the Food and Drug Law Institute, and the American Health Lawyers Association. It provides a detailed summary of: the enforcement authorities, both state and federal, tasked with rooting out violations; the anti-kickback statute and its implications; the False Claims Act; appropriate labeling, advertising, and promotion activities; compliant processes to develop and obtain approval for drugs and devices; coverage and reimbursement of prescription pharmaceuticals and medical devices; the Foreign Corrupt Practices Act; privacy and data protection; spend and marketing disclosure laws; components of an effective compliance program; and prescription drug price regulation.

Both the Gibbons Criminal Defense Department and its Health Care Team are nationally recognized for their health care fraud and abuse practice, with the Chambers USA Guide to America’s Leading Lawyers for Business listing Mr. Levy among the top practitioners in the state. In its similarly high ranking of the firm’s overall health care practice, Chambers has noted, “Gibbons has had an active year defending a variety of health care clients who have been accused of violating the False Claims Act … Clients are particularly quick to praise the group for its superb client service and excellent subject matter expertise.”

For more information on the Pharmaceutical and Medical Device Compliance Manual visit http://www.lexisnexis.com/ahla/ProductDetail.