BNA Books Announces the 2011 Supplement to “Pharmaceutical Law: Regulation of Research, Development, and Marketing”

BNA Books, a division of specialized news and information publisher BNA, today announces the publication of the 2011 Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing, providing important updates on securities cases and developments involving fraud and abuse, HIPAA, and the FDA. The treatise is one of the many ABA/BNA publications available from BNA Books. 

Pharmaceutical Law: Regulation of Research, Development, and Marketing  is the only resource available that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. No other single volume discusses these complex issues in so much detail and offers the information required by transactional health care attorneys to adequately advise clients on the opportunities-and the liabilities-in this industry. This treatise addresses the considerable fraud-and-abuse risks unique to this submarket of the health care industry; covers off-label marketing-selling a drug for a purpose other than its intended use; and explains and discusses other hot risks areas, including the potential for antitrust, securities law, and other compliance violations. 

The Medicare Part D drug benefit, coupled with the confusing and cumbersome methodology used for reimbursement, has added pressures to the already strained Medicare budget, increasing regulatory scrutiny and creating traps for the unwary and uninformed. Other increasingly important areas-including reimbursement and regulation, civil and regulatory liability under the securities and antitrust laws, and compliance and corporate governance issues-also are receiving increased attention from regulators. 

The 2011 Cumulative Supplement  includes discussion of: 

• The indictment of an FDA chemist for insider trading
• Foreign Corrupt Practices Act enforcement action against Johnson & Johnson related to unlawful payments and kickbacks
• The renewed importance of the Responsible Corporate Officer Doctrine
• The 2010 Amendments to the Organizational Sentencing Guidelines and their impact on how companies can benefit by structuring their compliance programs in specific ways
• The HITECH Act and its various requirements, including breach notification, restrictions on remuneration for PHI, and penalties
• The heightened emphasis on HIPAA Enforcement
• The Future of FDA Regulatory Authority and the FDA's Initiatives for 2011-2015
• The expansion of FDA authority by Title VII of PPACA and the Biologics Price Competition and Innovation Act of 2009 (BPCIA)  

The treatise was published in cooperation with the ABA Health Law Section. Section publications provide a balanced forum for the views and professional development of practitioners in health law. For more information on Section participation, please call the Section at 312.988.5824 or visit www.americanbar.org/groups/health_law.html. 

The editor-in-chief of Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2011 Supplement is Michael E. Clark, Special Counsel with Duane Morris, LLP, Houston, TX, and Adjunct Professor of Law at the University of Houston Law Center, who previously served as Chief of the Criminal Division of the U.S. Attorney's Office for the Southern District of Texas.