Cathy L. Burgess has joined the Washington, D.C., office of Alston & Bird as a partner in the firm's expanding food, drug and medical device practice. Ms. Burgess, a former associate general counsel for the American Red Cross, joins the team which Rep. Billy Tauzin (R-LA), the former President of the Pharmaceutical Research Manufacturers Association (PhRMA) and former Chairman of the House Energy & Commerce Committee, recently joined. The firm's FDA practice group is currently led by, Marc J. Scheineson, former FDA Associate Commissioner, Donald E. Segal, former FDA Associate Chief Counsel, and Paula Stannard, former acting General Counsel of the Department of Health and Human Services.
"FDA regulates products that comprise approximately 25% of the spending of each American consumer," said Richard R. Hays, the Firm's Managing Partner. "Cathy joins an experienced team that offers our health product clients the most complete spectrum of creative regulatory advice from the research bench to the patient's bedside."
Ms. Burgess's practice focuses on regulatory/manufacturer compliance, product risk management, enforcement and policy matters affecting industries regulated by the FDA. She advises clients on a wide range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics and has extensive experience in the area of current good manufacturing practices (CGMPs). In 1992, she served on the defense team in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs. Cathy has successfully represented prescription drug and medical device clients in significant FDA enforcement matters. She joins a team experienced in finding the "regulatory course of least resistance" for products in the U.S. marketplace.
Prior to joining the firm, Cathy served the American Red Cross as regulatory counsel and Associate General Counsel. One of her primary responsibilities included providing legal assistance and strategic advice to senior Red Cross management and the Board of Governors' Audit Committee related to compliance with the Red Cross Amended Consent Decree with FDA. Cathy comes directly from the Washington D.C. office of the law firm of Crowell & Moring.
Ms. Burgess earned her J.D. from Catholic University of America, Columbus School of Law, and her B.S.F.S. from Georgetown University. She is a member of the American Health Lawyers Association, the American Association of Blood Banks and the Food and Drug Law Institute.