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BNA Books Announces the Publication of the 2011 Cumulative Supplement to "Pharmaceutical Law: Regulation of Research, Development, and Marketing"

ARLINGTON, Va., Jan. 10, 2012 /PRNewswire-USNewswire/ -- BNA Books, a division of specialized news and information publisher BNA, today announces the publication of the 2011 Cumulative 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

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.

BNA, a wholly-owned subsidiary of Bloomberg L.P., is a leading source of legal, regulatory, and business information for professionals. In addition to Pharmaceutical Law: Regulation of Research, Development, and Marketing, BNA's Book Division publishes: E-Health, Privacy, and Security Law; Health Care Fraud and Abuse: Practical Perspectives; Managed Care Litigation; Prosecuting and Defending Health Care Fraud Cases; and other titles in health law. For a free BNA Books catalog, call 1.800.960.1220, send an e-mail request to, or visit us online at  

Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2011 Supplement may be purchased alone (Order #1995-PR11/$230.00 plus tax, shipping, and handling) or with the main volume (Order #9995-PR11/$485.00 plus tax, shipping, and handling) from BNA Books, PO Box 7814, Edison, NJ 08818-7814. Telephone orders: 1.800.960.1220. Fax orders: 1.732.346.1624. A 10% discount is available on print copies of books when ordering from the website at  Please note that discounts cannot be combined.

Editors: Review copy available upon request.
Please e-mail Matt Greene at, or call 703.341.5767.

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