BOOK

Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition, With 2016 Supplement

The new and expanded Second Edition of Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, offers readers a comprehensive and readable text about the dynamic and complex area of pharmaceutical and medical device law in a changing health care landscape, and more.

MEET THE AUTHORS
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Michael E. Clark
Editor-in-Chief

DESCRIPTION

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

The new and expanded Second Edition of Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing,offers readers a comprehensive and readable text about the dynamic and complex area of pharmaceutical and medical device law in a changing health care landscape. In this unique treatise, expert authors analyze and organize legal developments affecting the expansive regulatory arena covering drug creation, production, and sales.

With the graying of the Baby Boomer generation and the financial pressures that this group’s increased health care needs have made on federal and state governments, more and more attention is directed to drug costs and the profits of pharmaceutical manufacturers. The federal government’s increased reimbursement for pharmaceutical products under Medicare Part D has created a corresponding pressure on regulators and prosecutors to ensure that providers and pharmaceutical entities do not violate any of a number of applicable statutes and agency regulations. Obtaining a solid understanding about this area of health care practice is critical for transactional attorneys, for lawyers who counsel clients about compliance considerations, and for litigators who get involved in some of these complex cases. Annual supplements to the treatise will be invaluable in tracking changes to the relevant laws and how they are interpreted by the government and the courts.

Highlights in Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition include brand-new chapters on:

  • Pharmaceutical Compounding–Understanding the Blurred Line Between Manufacturing and Traditional Pharmacy
  • Regulation of Dietary Supplements
  • Ethics in Research
  • Regulation of Medical Devices

The Second Edition also provides:

  • A thoroughly revised chapter on the Federal Regulation of Advertising, Promotion, and Distribution Practices, including expanded discussions of FDA’s prescription drug advertising regulations, FDA’s regulation of over-the-counter (OTC) drugs, and Supreme Court rulings on federal preemption of state law-based tort actions for OTC drugs, prescription drugs, and medical devices
  • Discussion of decisions recognizing and extending constitutional free speech protections for off-label prescribing in Caronia and Amarin
  • Regulation and guidance related to research misconduct in clinical trials
  • New discussion of biologic and biosimilar products, the Biologic Price Competition and Innovation Act, and the biosimilar market
  • A thoroughly revised chapter on State Regulatory Schemes for Pharmaceuticals and Related Issues, including advertising guidance on direct-to-consumer sales and regulation of pharmacy benefit managers
  • Analysis of Supreme Court decisions on reverse payments in Actavis v. FTC and its progeny, and the State Action Doctrine in FTC v. Phoebe Putney Health Sys., Inc.
  • Expansion of the chapter on securities law to address life sciences companies
  • And much more.

Supplement Information

The 2016 Supplement includes: 

  • the U.S. Supreme Court's decision in Escobar, and the implied certification theory of liability under the False Claims Act
  • a new section on the FDA's draft guidance on compounding prescription requirements for traditional compounding pharmacies, those within a hospital, and standalone pharmacies under Section 503A of the Federal Food, Drug, and Cosmetic Act
  • FDA settlements with Amarin Pharmaceuticals and Pacira Pharmaceuticals indicating an evolution in the FDA’s attitude towards off-label promotion
  • recent HIPAA settlements, as well as developments in HIPAA enforcement, including the OIG’s call for stronger oversight by the OCR of HIPAA’s Privacy Rule and breach enforcement efforts
  • guidance from the FDA on the Zika virus and managing blood supply risks

     

  • significant updates on biologic and biosimilar products law, including Inflectra, the FDA’s second approved biosimilar, and new sections on biosimilar naming and labeling
  • proposed revisions to the Common Rule regulations for protection of human subjects in research, published by HHS and fifteen other federal departments and agencies
  • a new section on the OIG’s safe harbor under the Anti-Kickback Statute for electronic prescribing under Medicare Part D

     

  • antitrust caselaw updates on schemes to delay marketing of generics, as well as a decision on the relationship between ANDA filings and the minimum-contacts requirement for personal jurisdiction in two generics cases
  • other settlements with the federal government, including the $784.6 million Wyeth and Pfizer settlement under the False Claims Act, as well as the $646 million settlement with Olympus Corporation of the Americas, Inc. (OCA) which combined violations of the Anti-Kickback Statute, the False Claims Act, and the Foreign Corrupt Practices Act
  • litigation on securities law issues such as scienter, predictions of drug approvals, statements during IPOs, and the importance of loss causation

     

  • the FDA’s March 2016 update of its Manual of Policies and Procedures 5240.3, now containing a new category of expedited “sole-source” Abbreviated New Drug Applications (ANDA) submissions

 


AUTHORS

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.

 



CONTENTS

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