Michael Swit has been addressing critical U.S. Food and Drug Administration (FDA) legal and regulatory issues since 1984. Before returning to private law practice in late 2017, he served for three years at Illumina, Inc., the world’s leading developer of gene sequencing technology, as its chief regulatory counsel. Prior to that, Swit was a special counsel in FDA Practice at the global law firm of Duane Morris LLP in its San Diego office.
Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with an emphasis on drugs, biologics, therapeutic biotech products, medical devices, and IVDs, but also has experience with foods, cosmetics, and clinical research issues. His FDA legal experience has included tenures in the food and drug law practices McKenna & Cuneo (now Denton’s) and Heller Ehrman, and as vice president, general counsel, and secretary of Par Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the company’s recovery from prior management’s involvement in the Generic Drug Scandal of the late 1980’s. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his AB, magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University.