Pharmaceutical Law: Regulation of Research, Development, and Marketing + 2014 Cumulative Supplement

Special ABA Section member price

This resource provides transactional health care attorneys the information they need to effectively advise clients on the complex health care law issues unique to the pharmaceutical industry. It examines the interaction between pharmaceutical companies and health care delivery systems, insurers, and regulators, including fraud and abuse risks. It also covers off-label marketing issues, antitrust, securities law, and other compliance violations, as well as Part D reimbursement, and more.

Michael E. Clark


EXAMINES THE COMPLEX RELATIONSHIPS between the pharmaceutical industry and health care delivery systems, insurers, and regulators.

Pharmaceutical Law: Regulation of Research, Development, and Marketing provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. With the Medicare Part D drug benefit and the confusing methodology used for reimbursement adding pressures to the strained Medicare budget, increasing regulatory scrutiny, and creating traps for the unwary, practitioners need this resource to stay on top of the law. This treatise addresses fraud and abuse risks; off-label marketing; and the potential for antitrust, securities law, and other compliance violations; and more. 

Supplement Information

The 2014 Cumulative Supplement includes:

  • extensive new discussion of the New Drug Application process; analysis of the FDA’s 2013 final guidance recommending risk-based approaches to clinical investigations monitoring by trial sponsors
  • Coverage of the Drug Quality and Security Act of 2013
  • review of DOJ 2013 and 2014 settlements in pharmaceutical cases
  • discussion of Anderson v. Peregrine Pharms., Inc., a securities class action for false and misleading statements about the effectiveness of an experimental drug;
  • and other new developments


Bloomberg BNA authors and editors are practicing professionals with insider perspectives and real-life experience. Learn more about this book’s authors and editors.

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


View full tables of contents, preface or list of contributors.