Book

Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition, With 2017 Cumulative 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

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 2017 Cumulative Supplement discusses: 

  • Amendments to the Common Rule protecting human research subjects, including changes on informed consent, research with biospecimens, exemptions, and IRB criteria

  • New FDA guidance on off-label promotion as well as key advertising guidance on issues such as inclusion of disease information, and character-space-limited communications in social media

  • Updates on numerous HIPAA enforcement actions related to data breaches and disclosure of protected health information

  • OIG’s final rule amending existing anti-kickback safe harbors, adding new safe harbors, and clarifying the definition of remuneration under civil monetary penalties

  • The DOJ’s evaluation of corporate compliance programs guidelines, as well as the DOJ and SEC’s resource guide to the U.S. Foreign Corrupt Practices Act

  • Updates on state laws which impact Pharmacy Benefit Manager Laws

  • FDA guidance on pharmaceutical compounding, including bulk drug substances and “essentially copies” of commercially available drugs

  • FDA memoranda on communication of unapproved uses and the First Amendment, and on communication with payors and similar entities

  • Contrasting applications of Escobar by lower courts in false claim act action

  • FDA industry guidance regarding nonproprietary names of originator biologics, related biologics, and biosimilars

 

Authors

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

 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.

 

  

  
Contributors

 

Contents

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