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Howard Dorfman

Howard, click here to claim your profile for free! Ropes & Gray

48 years of experience
Business Law
New York, New York, 1976

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Practice Area

Business Law

Additional Practice Area

Corporate

Jurisdictions Admitted to Practice

New York
Since 1976

New York, 1976

Professional Experience

Counsel: Ropes & Gray; Current

: Current; 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. His major areas of expertise 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.

Education