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Howard L. Dorfman
Counsel
Ropes & Gray
1211 Avenue of the Americas
New York, NY 10036-8704
T + 1-212-596-9114
F + 1-646-728-2858
+ 1-212-596-9231 secretary
E-mail
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Practice
Howard Dorfman is counsel in Ropes & Gray's Life Sciences Group in New York. He focuses his practice in compliance management, fraud and abuse, and FDA regulatory law. An experienced strategic advisor, Howard also counsels clients on mergers and acquisitions, corporate governance, licensing and antitrust matters.
Professional Experience
Howard's practice focuses on the pharmaceutical and biotech industries. As a former chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, he was responsible for legal oversight relating to the commercial, regulatory and compliance activities of the company's pharmaceutical operations. The major areas of his practice include FDA regulatory law; fraud and abuse; compliance programs; risk management processes; mergers and acquisitions; corporate governance; licensing and antitrust.
Howard also worked at Bristol-Myers Squibb for 23 years. First, as counsel for litigation, he oversaw and directed nationwide mass tort litigation involving hormones, antibiotic (tetracyline), and medical device (silicone implant) products. In 1997, 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.
With over 30 years of industry experience, Howard has intimate knowledge of the PhRMA Code, 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, Howard has developed FDA risk management plans and global drug labeling protocols in accordance with U.S. regulatory standards. Having lead major alliance and restructuring negotiations, Howard brings his substantive understanding of a business' focus and needs to each representation.
Publications
- Author, The 2009 Revision to the PhRMA Code on Interactions with Health Care Professionals: Challenges and Opportunities for the Pharmaceutical Industry in the Age of Compliance, Campbell University Law Review (volume 31, pp. 361-377)
- Author, "Bringing Sanity to Toxic Torts: A Practical Approach to the Use of Epidemiology," 3rd International Conference on Pharmacoepidemiology (1987)
- Co-author, Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate, 61 Food and Drug Law Journal (2006): 535-571
- Avoiding Legal and Ethical Pitfalls of Industry-Sponsored Research: The Co-Existence of Research, Scholarship, and Marketing in the Pharmaceutical Industry, 59 Food and Drug Law Journal (2004): 595-615
- Dot.com Medicine - Labeling in an Internet Age, 56 Food and Drug Law Journal (2001): 143-178
- Surfing the Net in Shallow Waters: Product Liability Concerns and the Internet, Food and Drug Law Journal (1998): 213
- The Learned Intermediary Doctrine: The Correct Prescription for Drug Labeling, 48 Rutgers Law Review (1996): 821
- Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense, 24 Seton Hall Law Review (1994): 1437
Bar Admissions
Courts
- Supreme Court of the United States, 1998
Education
- 1975,
J.D., Brooklyn Law School
- 1971,
B.A., Yeshiva University
©2010 Ropes & Gray LLP. All rights reserved.
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