Alan, managing partner of the DC office, has advised clients on issues involving pharmaceutical marketing and promotion for more than 25 years. Alan counsels clients and represents them at the FDA and in Congress on many of the critical issues that affect the pharmaceutical industry. He is a recognized expert on the Hatch-Waxman Act and lifecycle management, and is co-author of The Legislative History of the Drug Price Competition and Patent Term Restoration Act. Alan also has extensive experience in biological products, including the new biosimilars legislation, in food additive approvals, orphan drugs, and in over the counter drugs and the procedures used to switch them from prescription to non-prescription status.
Alan began his legal career in the Office of the General Counsel of the Food and Drug Administration, where he was a trial and appellate lawyer and legal advisor to several FDA bureaus. Subsequently he was legislative assistant to the late Senator Jacob Javits and Special Counsel to the Senate Governmental Affairs Committee, where he concentrated on a wide variety of regulatory matters, consumer protection and administrative law issues, including playing a major role in one of the first medical records privacy initiatives. After leaving the Hill, Alan co-founded a food and drug boutique firm that was ultimately known as Bennett, Turner and Coleman, which merged into Ropes & Gray in 2002.
Alan is also a former co-chair of Ropes & Gray’s Life Sciences Practice Group.
- Co-leader of the Medical Information Working Group, a coalition of more than a dozen pharmaceutical and device manufacturers, interested in seeking clarity in government policies governing promotional practices.
- Prepared several successful citizen petitions to FDA on behalf of innovator pharmaceutical manufacturers regarding appropriate standards for bioequivalence and “sameness” for potential generic entrants.
- Provided Hatch-Waxman advice to assist litigators in an extremely complex ANDA patent litigation.
- Conducted internal investigations of marketing practices in response to whistleblower complaints.
- Assisted two major manufacturers during Congressional consideration of biosimilars legislation.
- Helped draft compliance standards on numerous topics involving off-label dissemination and anti-kickback standards for several companies.
Honors & Awards
Chambers USA: America's Leading Lawyers for Business (2006-2011) Who's Who in American Law (2011) PLC Which Lawyer (2010-2011)
Professional & Civic Activities
- Editorial Advisory Board Member, Thompson Medical FDA Advertising and Promotion Manual
- Adjunct Professor of Food and Drug Law, University of Connecticut School of Law
- Director, University of Connecticut Foundation
- Director, Brady Center to Prevent Handgun Violence
©1996-2012 Ropes & Gray LLP. All rights reserved.
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Education
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JD, Columbia Law School, 1972; Harlan Fiske Stone Scholar
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BA, University of Connecticut, 1969; with Honors
Bar Admissions
- District of Columbia, 1973
- New York, 1973
Memberships & Affiliations
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