COLEEN KLASMEIER, a partner in the Washington, D.C., office, is ranked among the nation’s top FDA lawyers. She has been a member of the firm’s Executive Committee since 2015 and is global leader of the Food, Drug and Medical Device Regulatory group.
Since joining Sidley from the Food and Drug Administration (FDA) Office of the Chief Counsel in 2005, Coleen has concentrated her practice on contentious proceedings involving the Agency, and on regulatory strategy and risk management. She has served as regulatory counsel to a wide range of life sciences companies in investigations; civil litigation including product liability, consumer fraud, Hatch-Waxman, and appellate matters; and Congressional investigations.
Coleen is Band 1 in Chambers USA for Pharmaceutical/Medical Products Regulatory. Chambers Global (2021) reports the client comment, “she is very responsive, has a wealth of FDA knowledge and is a strategic thinker." Chambers USA, D.C. (2021) remarks, “she is super smart, well connected and very hard-working” and “she is just the best of the best in terms of food and drug counsel. She's a complete rock star." Coleen’s accolades include Chambers Global, Chambers USA (Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance), The Best Lawyers in America, and Best Lawyers (2014–2020). She is also recognized in The Legal 500 Hall of Fame (2021), Washington DC Super Lawyers, Who’s Who Legal, and LMG Life Sciences (including Regulatory Attorney of the Year, 2017).
Coleen taught food and drug law at Northwestern University Law School in 2014.