700 12th Street, NW, Suite 900
Washington, District Of Columbia 20005
Alan 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.
|Areas of Practice||1) Life Sciences and 2) FDA Regulatory|
|Law School||JD, Columbia University School of Law, 1972; Harlan Fiske Stone Scholar|
|Education||BA, University of Connecticut, 1969; with Honors|
|Bar Member / Association||New York State Bar Association, District of Columbia Bar Association|
|Most recent firm||Ropes & Gray LLP|
Ms. Fitzgerald represents employers in a wide range of industries, including the entertainment, financial services, hospitality, manufacturing, retail, and transportation industries.
Ms. Shander advises public and private company clients as well as private equity funds, with an emphasis on mergers and acquisitions, dispositions, and financing transactions.