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Pharmaceutical Compliance and Enforcement Answer Book (2014 Edition)

Author(s): Howard L Dorfman
Practice Area: Enforcement (Life sciences), Life sciences, Pharmaceuticals
Date: Jan 2014 i Other versions can be found in the Related Items tab.
ISBN: 9781202421167
PLI Item #: 53632

PLI's Pharmaceutical Compliance and Enforcement Answer Book 2014 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2014 describes:

  • The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency
  • A facility's rights and compliance obligations during an inspection by the agency
  • How to best evaluate a company's potential of being in violation and what to do to mitigate those risks
  • What advertising and promotion of prescription drugs is permitted
  • How product liability issues overlap with FDA enforcement initiatives
  • When criminal prosecution is used as part of the regulatory enforcement effort

Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book 2014 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations.

Howard L. Dorfman is the founder of H.L. Dorfman Pharmaceutical Consulting which provides compliance, regulatory and risk management consulting services to pharmaceutical and biotech companies. Previously, Mr. Dorfman has served in various senior capacities in national and international companies in the health sector.Mr. Dorfman has served as Vice President and General Counsel at Ferring Pharmaceuticals, Inc. in Parsippany, New Jersey where he was responsible for all legal matters relating to the U.S. affiliate of a Swiss-based global pharmaceutical and biotech company. Previously, he servedas a Counsel in the Life Sciences group at Ropes & Gray LLP in New

York, where he focused his practice on the pharmaceutical, medical device, and biotech industries. Mr. Dorfman’s areas of expertise include FDA regulatory law, fraud and abuse, compliance programs, risk management processes, mergers and acquisitions, corporate governance and licensing, and product liability. Prior to his time at Ropes & Gray, he was chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory, and compliance activities of the company’s pharmaceutical operations. Before joining Bayer, he worked at Bristol-Myers Squibb (BMS). First, as Counsel for litigation, he oversaw and directed nationwide mass tort litigation involving hormones, antibiotic (tetracycline), and medical device (silicone implant) products. Later, he became Counsel to the company’s U.S. Medicines Group, where he was responsible for the legal functions relating to the two largest prescription pharmaceuticals in the Bristol-Myers cardiovascular franchise. Mr. Dorfman has knowledge of the PhRMA Code, Office of the Inspector General (OIG) compliance, and FDA-related legislation as well as federal and state fraud and abuse regulations and statutes. He established OIG compliance procedures at a major pharmaceutical company while counseling on Medicare, Medicaid, and other healthcare reimbursement matters. Liaising with international stakeholders, he has developed FDA risk management plans and global drug labeling protocols in accordance with U.S. regulatory standards. He has lectured and published articles on a range of product liability and FDA regulatory issues. Mr. Dorfman received his B.A. with honors from Yeshiva University and his J.D. from Brooklyn Law School.