COLEEN KLASMEIER leads the firm’s product 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 regulatory strategy and risk management, and on FDA litigation and dispute resolution. 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:
- Serving as FDA counsel in multiple off-label enforcement actions and internal reviews for major biopharmaceutical and medical device manufacturers;
- Serving as FDA counsel in numerous litigation matters, including most recently the following:
– United States v. Caronia, No. 09-5006-cr (2d Cir. decided Dec. 3, 2012) (amicus);
– Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), appeal pending;
– Sottera, Inc. v. FDA, No. 10-5032 (D.C. Cir. decided Dec. 7, 2010) (amicus);
– United States v. Harkonen, Nos. 11-10209 & 11-10242 (9th Cir. argued Dec. 6, 2012); and
– Harkonen v. Dept. of Justice, No. 12-629 (N.D. Cal. dismissed Dec. 3, 2012).
- Representing the Medical Information Working Group (MIWG), a coalition of leading manufacturers of biopharmaceutical and medical technology products seeking clarity in 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 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) inquiries and advising on promotional issues for brands across therapeutic areas;
- Representing innovator clients in Hatch-Waxman and other market access matters involving 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 one of the nation’s top-tier groups. Chambers USA also rates the group among the country’s best, 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. She is highly ranked by The Practical Law Company in The Cross-Border Life Sciences Handbook (since 2007); The Legal 500 United States (2011); and Who’s Who Legal 100 (2012). In 2009, Coleen was named by Washingtonian magazine one of the DC area’s Top FDA Lawyers.