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BNA Books' Announces Publication of NEW 2010 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing

Arlington, Va., December 2010 – BNA Books, a division of specialized news and information publisher BNA, announces the publication of the the 2010 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's (ABA) Health Law Section.

Pharmaceutical Law: Regulation of Research, Development, and Marketing 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 FDA approved 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 2010 Cumulative Supplement is updated with new topics, including:

  • The new and heightened risks and compliance and reporting obligations likely to emerge from the new SEC whistle blower provisions authorized by Congress in the Dodd-Frank Act for publicly traded pharmaceutical and medical device manufacturers
  • Discussion of the Congressionally approved pathways for generic manufacturers to develop and market bioengineered drugs, and how they compare to and differ from ANDAs under the Hatch-Waxman Act
  • Growing fraud and abuse risks for pharmaceutical manufacturers under the Foreign Corrupt Practices Act and other government initiatives

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

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Press Contact:
Matthew Greene
(703) 341-5767
mgreene1@bna.com

Michael E. Clark is the author of the treatise and its supplement. Mr. Clark is a member in Duane Morris 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, 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 books@bna.com. The BNA Books website, including an online catalog, can be found at bnabooks.com.

The 2010 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing may be purchased alone (510 pp. Softcover/Order#1910-PREL10/$225.00 plus tax, shipping, and handling), or with the main volume (899 pp. Hardcover/Order #9910-PREL10/$480.00 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 when ordering from the website at bnabooks.com. Please note that discounts cannot be combined.

Editors: Review copy available upon request.
Please e-mail Matt Greene at mgreene1@bna.com, or call 703-341-5767.