FacultyFaculty/Author Profile

Howard L. Dorfman

H. L. Dorfman Pharmaceutical Consulting, LLC

West Orange, NJ, USA


Howard L. Dorfman is 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 served as 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.
Howard L. Dorfman is associated with the following items:
Answer Book Chapters  Answer Book Chapters Overview of the FDA Regulatory Process Pre- and Post-Approval and the 21st Century Cures Act - Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition), Tuesday, May 22, 2018
Current Status of the Impact of the First Amendment on Off-Label Promotion - Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition), Tuesday, May 22, 2018
Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers - Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition), Tuesday, May 22, 2018
Regulatory and Compliance Implications of Disseminating Medical Information and the Distinction with Off-Label Promotion - Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition), Tuesday, May 22, 2018
Answer Book  Answer Book Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition) - Pharmaceutical Compliance and Enforcement Answer Book (2017 Edition)
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