Compliance counsel for pharmaceutical companies are becoming more involved in “off-label” promotion and marketing issues than in the past. Compliance counsel — both inside the corporation and in their outside law firms — are in great demand as a result of increased governmental informal inquiries, informational subpoenas and formal investigations. Both corporate law departments and outside law firms are adding to their compliance departments to service the needs of their clients on an expanding basis.

The Department of Justice and U.S. Attorneys Offices throughout the country are increasingly targeting the sales and marketing practices of pharmaceutical companies and, in particular, such companies’ off-label marketing. Federal prosecutors have benefited from increases in funding, personnel and other resources at various federal agencies seeking to investigate and deter health care fraud, including the Department of Health and Human Services and the Food and Drug Agency’s Office of Criminal Investigations.