WASHINGTON, D.C. — Buchanan Ingersoll & Rooney PC has announced the addition of shareholder James S. Cohen to its Food and Drug Practice in Washington.

Having spent the last 17 years in senior-level positions with the U.S. Food and Drug Administration (FDA), Cohen brings a wealth of regulatory insight regarding the development and marketing of drugs, biologics, devices and combination products.

Established more than seven years ago, Buchanan's Food and Drug Practice is one of the first and largest practices dedicated to helping clients with issues related to the FDA.  Half of the attorneys in the Food and Drug Practice previously worked with the FDA and the rest worked for drug companies and research institutes as scientists or legal counsel.

Cohen focuses on the development and marketing of new products and business opportunities in the areas of drugs, biologics, devices and combination products.  He advises clients on all aspects of the premarket and postmarket regulation of these products, and in addressing and resolving compliance and enforcement matters.

Most recently, Cohen was senior advisor to the FDA's Office of Combination Products, in the Office of the Commissioner, where he addressed and resolved regulatory pathway and product development issues, determined product jurisdiction and developed and oversaw regulatory, compliance and postmarket strategies and programs for combination products.

Before his role as senior advisor, Cohen served for five years in the FDA's Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research.  There, he was deputy director and then acting director, where he managed its manufacturing quality, compliance, clinical investigation monitoring, inspection, enforcement and import/export programs for biological products.

Cohen served as associate chief counsel in the FDA's Office of the Chief Counsel for eight years.  There, he worked on a variety of legal, regulatory and compliance matters, including serving as legal counsel to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and as the FDA's legal counsel to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.  He also served as an enforcement attorney, conducting civil and criminal litigation in all major product areas regulated by the FDA. In this capacity, he also served as special assistant U.S. attorney in three jurisdictions, prosecuting FDA cases.

Before joining the FDA, Cohen was an attorney in a Washington, D.C., law firm, representing companies and businesses in civil and criminal litigation (including government and independent counsel investigations).  He was also a trial attorney in the Department of Justice and a judicial law clerk in the Territorial Court of the U.S. Virgin Islands.

Cohen received his J.D. from Georgetown University Law Center and his B.A., with honors, from the University of California at Santa Cruz.  He has spoken on FDA regulation at numerous conferences and programs, domestically and internationally, to product manufacturers, industry organizations and government officials.  Cohen served on several agency steering committees, including the commissioner's Anti-Counterfeiting Task Force and the agency's GMPs for the 21st Century Initiative and the commissioner's Anti-Counterfeiting Task Force.  Cohen received numerous awards at the FDA, including the Award of Merit and Distinguished Service awards.

Buchanan Ingersoll & Rooney PC has more than 550 attorneys and government relations professionals practicing throughout the United States, with multiple offices in California, Florida, New Jersey, New York and Pennsylvania, as well as offices in Delaware, Virginia and Washington, D.C.