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Pharmaceutical Law: Regulation of Research, Development, and Marketing

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A Cumulative Supplement to this volume is now available. Order now. 

Main Volume Information

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. In fact, 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.

Pharmaceutical Law: Regulation of Research, Development, and Marketing is a reference attorneys will turn to time and again for answers and guidance in all areas of pharmaceutical law.

 

Supplement Information

The  2013 Cumulative Supplement provides important updates on securities cases and developments involving fraud and abuse, HIPAA, and the FDA, including analyses concerning:

  • Analysis of CMS’s final regulations under the Sunshine Act detailing applicable manufacturer and group purchasing organizations’ reporting requirements
  • Discussion of FDA’s updated guidelines for industry and investigators clarifying safety reporting requirements for IND studies, bioavailability and bioequivalence studies
  • Discussion of OIG’s substantial revisions to the Self-Disclosure Protocol in the “Updated OIG’s Provider Self-Disclosure Protocol”
  • Analysis of Supreme Court’s holding in Federal Trade Commission v. Actavis, Inc.,  which settled a circuit court split holding that the rule of reason is the standard to apply in antitrust cases alleging violations arising from patent settlements tied to ANDA litigation
  • Discussion of latest FDA technical report on direct to consumers television and print advertisements for prescription drugs 

Main Volume Information

About the Editor-in-Chief
Michael E. Clark is Special Counsel with Duane Morris, LLP, Houston, Texas, and Adjunct Professor of Law at the University of Houston Law Center. Previously, he served as Chief of the Criminal Division of the U.S. Attorney’s Office for the Southern District of Texas. 
ABA Health Law Section


Supplement Information

Michael E. Clark, Editor-in-Chief, ABA Health Law Section

Main Volume Information

 2007/899 pp. Hardcover/ABAWEB1576


Supplement Information  

2013/634 pp. Softcover/ISBN 978-1-61746-323-5/ABAWEB2323  

Order 2013 Cumulative Supplement now.