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.
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