COLEEN KLASMEIER leads the firm’s Food, Drug and Medical Device Regulatory practice within the global Life Sciences team, managing matters on behalf of the world’s leading biopharmaceutical, medical technology, and food and consumer product companies. Since joining Sidley from the Office of the Chief Counsel at the Food and Drug Administration in 2005, Coleen has concentrated her practice on FDA litigation and dispute resolution, and on regulatory strategy and risk management. She has been deeply involved as FDA regulatory counsel in defending numerous off-label marketing investigations, as well as in a wide variety of product liability, consumer fraud, Hatch-Waxman, criminal, and appellate matters on behalf of life sciences industry clients.
Coleen serves as FDA regulatory counsel to such companies as GlaxoSmithKline, Kimberly-Clark and Roche Diagnostics. Coleen’s experience includes:
- Successfully representing medical technology and consumer product companies in jurisdictional disputes with FDA, including a successful challenge to an Office of Device Evaluation (ODE) determination under Section 513(g) of the FDCA that a cosmetic product was properly regulated as a medical device;
- Successfully representing general hospital use device manufacturers in disputes with FDA's Office of Regulatory Affairs (ORA) and CDRH arising out of Quality System Regulation (QSR) investigations;
- Serving as FDA counsel in multiple off-label enforcement actions, DOJ investigations (both civil and criminal), and internal reviews for major biopharmaceutical and medical device manufacturers;
- Serving as FDA counsel in numerous litigation matters:
- United States v. Harkonen, 510 Fed. Appx. 633 (9th Cir.) (First Amendment challenge to wire fraud conviction for statements in press release announcing results of Phase III clinical trial), cert. denied, 134 S. Ct. 824 (2013);
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (counsel for amicus curiae Medical Information Working Group);
- Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff'd sub nom Cook v. FDA, No. 12-5176 (D.C. Cir. July 23, 2013) (counsel for plaintiffs);
- Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010) (counsel for amicus curiae Washington Legal Foundation); and
- Harkonen v. Dept. of Justice, No. 13-15197 (9th. Cir.) (Information Quality Act challenge to false statements of fact in DOJ press release announcing conviction) (pending).
- Representing the Medical Information Working Group (MIWG), a coalition of leading manufacturers of biopharmaceutical and medical technology products seeking changes to the FDA rules governing the dissemination of truthful, non-misleading information about off-label uses;
- Handling FDA dispute resolution proceedings on behalf of manufacturers adversely affected by threatened refusal-to-file and complete response actions for innovative/orphan biopharmaceutical products;
- Leading internal reviews of manufacturer copy review processes for internal approval of marketing materials;
- Representing manufacturers in Office of Prescription Drug Promotion (OPDP) regulatory letters, inquiries and advisory comment proceedings and advising on promotional issues for brands across therapeutic areas;
- Representing innovator clients in Hatch-Waxman and other market access matters involving complex-formulation products and drugs with unique risks;
- Representing innovator manufacturers before the FDA advocating enforcement of New Drug Application (NDA) requirements for unapproved drugs;
- Strategic counseling and regulatory analysis for post-acquisition risk mitigation with respect to products having significant off-label use; and
- Developing and implementing risk mitigation strategies for companies marketing borderline cosmetic products.
Through Coleen’s leadership, the firm’s FDA regulatory practice has grown into a full-service group that is frequently recognized in legal and industry publications for its significant regulatory experience and in-depth industry knowledge. USNews rates the FDA practice as among the nation’s very best. Chambers USA recognizes Sidley as a leading firm for FDA regulatory work, noting in its 2012 edition that, “This highly regarded firm is applauded for its all-encompassing approach to the various industry sectors within the healthcare and FDA space.” In 2011, Chambers USA said of the group: “Sidley Austin has developed a successfully integrated healthcare and FDA practice, widely viewed as the premier service provider for some of the leading medical device and pharmaceutical companies. Clients particularly praise its expertise in regulatory compliance . . . .”
Praised by clients for her “broad experience” and attentiveness to client needs, and her “tremendous” and “encyclopedic” knowledge of FDA rules, history, and contacts (Chambers USA 2011-2012), Coleen was also named a “Life Sciences Star” in the inaugural edition of LMG Life Sciences 2012 and has been highly ranked by The Practical Law Company in The Cross-Border Life Sciences Handbook (2007-2012). Since 2012, Coleen has been recommended by Who’s Who Legal, which reports in its 2013 edition that she is “tremendously knowledgeable about all aspects of regulation” in the life sciences sector. Coleen is recognized in the 2014 edition of Best Lawyers for her FDA practice, and has been included in the Legal 500 US (2011, 2013-2014). In the 2013 edition of Chambers USA, a source notes that Coleen is “a walking dictionary of FDA case law." Washingtonian magazine has included Coleen on its list of Washington’s Best Lawyers as one of the region’s “best legal minds” in the area of Food & Drug Law (2013 and 2009).
Coleen is an adjunct professor at Northwestern University Law School and taught food and drug law in spring 2014.