AHLA, American Health Lawyers Association

Product Detail


Pharmaceutical and Medical Device Compliance Manual, First Edition (AHLA Members)
American Health Lawyers Association; Seton Hall; Food and Drug Law Institute (FDLI)
Price: $144.00
Publisher: AHLA
Format: Softbound with CD-ROM, 350 pages,BOOK
ISBN: 9780769849560
5/2014
Description
Table of Contents »

If you are not an AHLA member and would like to purchase this book, click here.
Seton Hall click here.
FDLI click here.

The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.

Coverage includes:

•  In-depth coverage of the federal and state enforcement agencies
•  Federal Anti-Kickback Statute and False Claims Act details
•  Distinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label use
•  Discussion of the Foreign Corrupt Practices Act and its extra-territorial reach
•  Coverage and reimbursement of prescription drugs and medical devices
•  Prescription drug price regulations

The Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.

EDITORS

Kathleen M. Boozang, J.D., LL.M.,
Professor of Law, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ
Simone Handler-Hutchinson, J.D., Executive Director, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ

CONTRIBUTING AUTHORS

Bret A. Campbell, Esquire;
Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ

Copyright© 2011 LexisNexis, a division of Reed Elsevier Inc. All rights reserved.
Terms & Conditions | Privacy & Security