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BNA Books' Announces Publication of New 2009 Cumulative Supplement to 'Pharmaceutical Law: Regulation of Research, Development, and Marketing'

ARLINGTON, Va., March 3 /PRNewswire-USNewswire/ -- BNA Books, a division of specialized news and information publisher BNA, announces the publication of the 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing. The main volume and supplement are published by BNA Books with the American Bar Association (ABA) Health Law Section.


Pharmaceutical Law: Regulation of Research, Development, and Marketing is the only resource that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. No other single volume discusses these complex issues in the detail required for transactional health care attorneys to adequately advise their 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
  • Explains and discusses the other hot risks areas—including the potential for antitrust, securities law, and other compliance violations
  • Discusses the securities law reporting obligations of drug companies for material events (such as the rejection of approval of NDAs), and how to protect clinical research subjects

The 2009 Cumulative Supplement is updated with new topics, including:

  • Kennedy-Enzi, the Enhancing Drug Safety and Innovation Act of 2006
  • The Food and Drug Administration Amendments Act of 2007
  • The FDA and preemption in the context of labeling and drug safety
  • FDA authority to regulate tobacco products
  • Changes to DTC marketing made by the Food and Drug Administration Amendments Act of 2007
  • The Health Information Technology for Economic and Clinical Health (HITECH) Act
  • HIPAA enforcement
  • Lanham Act violations
  • Class actions

This treatise also offers authoritative explanations of the complex inter-relationships between the pharmaceutical industry, health care delivery system, insurers, and regulators.

Michael E. Clark is the author of the treatise and its supplement. Mr. Clark is a member in Hamel Bowers & Clark LLP. He has a distinguished background in government and private litigation, having served as Chief of the Criminal Division of the U.S. Attorney's Office for the Southern District of Texas from 1993−1997.

BNA is a leading private publisher of news and information products for professionals in law and business. In addition to Pharmaceutical Law: Regulation of Research, Development, and Marketing with 2009 Cumulative Supplement, BNA's Book Division publishes Pharmaceutical Patent Law; Health Care Fraud and Abuse; Prosecuting and Defending Health Care Fraud; Managed Care Litigation; E-Health Business and Transactional Law; and other titles in legal specialties. For a free BNA Books catalog, call 1-800-960-1220 or send an e-mail request to The BNA Books website, including an online catalog, can be found at

The 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing may be purchased alone (344 pp. Softcover/Order#1823-PRY9/$220.00 plus tax, shipping, and handling), or with the main volume (899 pp. Hardcover/Order #9823-PRY9/$385.00 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.


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