US and International Codes on Pharmaceutical Marketing Practices and Interaction with Healthcare Professionals - A Comparative Analysis and Outlook on Harmonization by FCPA Enforcement
Roy Birnbaum, Senior Legal Director, Human Health International, Merck & Co, USA
In recent years, there has been an increasing focus on pharmaceutical marketing practices and interactions between pharmaceutical companies and healthcare professionals. Concerns about real and perceived improprieties have led to a progressive general tightening of standards as reflected both in mandatory regulatory requirements and voluntary codes of practice. However, there remains a significant gap between US and international standards as reflected respectively in the voluntary codes of practice issued by the US and international industry associations. The above described gap has surely not gone unnoticed by the authorities responsible for enforcing the US Foreign Corrupt Practices Act (FCPA), which have recently announced a new focus on the pharmaceutical industry. Remarks by Department of Justice (DOJ) officials in this connection have included reference to sharing expertise between the DOJ Fraud Section’s domestic health care fraud and FCPA teams. To the extent such information sharing results in the attempted harmonization of US and international standards on pharmaceutical marketing practices by FCPA enforcement, this could create significant exposure for multinational pharmaceutical companies.
Roy B. Birnbaum is senior legal director, international law, at Merck Co., Inc., Whitehouse Station, New Jersey. He is responsible for legal support to various global projects and transactions outside the United States. Prior to the global merger of Merck and Schering-Plough Corporation in November 2009, Mr. Birnbaum was responsible for general legal support to all of Schering-Plough’s operations in the Asia Pacific region, including Japan. Prior to joining Schering-Plough, Mr. Birnbaum held similar positions with Pfizer, Inc., Pharmacia Corporation and its predecessors, located in New Jersey, Hong Kong and Michigan. He has also worked as a foreign legal consultant with the law firm of Kim & Chang in Seoul, Korea and began his career in private practice in Washington, D.C. Mr. Birnbaum has a B.A. from Brandeis University and a J.D. from Harvard Law School. The author gratefully acknowledges valuable research assistance from Ms. Diana Diamond, solicitor with the firm of Arthur Cox, Dublin, Ireland, presently on secondment to the Merck international law department. The opinions expressed in this article are solely those of the author.
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