Coleen Klasmeier

Coleen’s experience includes:

• Advising a range of life sciences companies with respect to engagement with FDA during the COVID-19 pandemic, including Emergency Use Authorizations;
• Representing diagnostic technology companies with respect to premarket review issues, including those relating to software;
• Representing clinical laboratory clients in contentious proceedings involving pharmacogenomics and First Amendment and FDCA regulatory issues;
• Advising novel diagnostic technology companies on product development and regulatory pathway issues;
• Advising consumer product companies with respect to the Hemp Farming Act of 2018 and lawful pathways for the development and commercialization of products containing cannabidiol (CBD) and other ingredients derived from hemp;
• Advising tobacco product (including electronic nicotine delivery system, or ENDS) manufacturers with respect to public policy, regulatory, compliance, and litigation matters arising out of the FDA regulatory scheme;
• Serving as FDA regulatory counsel in connection with opioid-related litigation and associated regulatory matters;
• Developing advocacy to support innovative biopharmaceutical product developers and manufacturers in disputes and non-contentious proceedings involving FDA;
• Representing trade associations and individual member companies in rulemaking and guidance development proceedings before FDA;
• Assisting FDA-regulated entities in devising and implementing comprehensive public policy solutions to business problems, including broad-based legal reform efforts on behalf of biopharmaceutical product developers;
• Advising consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA);
• Representing innovator biological product developers on matters arising under the Biologics Price Competition and Innovation Act (BPCIA);
• Serving as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations;
• Successfully representing prescription drug manufacturers in contentious proceedings involving promotion issues before the Office of Prescription Drug Promotion (OPDP) and its predecessor Division of Drug Marketing, Advertising, and Communications (DDMAC);
• 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 Center for Devices and Radiological Health (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. Patrick Fabian, 1:15-cr-10076 (1st Cir.) (counsel for amicus curiae Medical Information Working Group);
  • United States v. William Facteau, 1:15-cr-10076 (1st Cir.) (counsel for amicus curiae Medical Information Working Group);
  • Harkonen v. Dept. of Justice, 800 F.3d 1143 (9th Cir. 2015) (addressing justiciability of Information Quality Act challenge to statements in DOJ press release announcing fraud conviction);
  • Pacira Pharmaceuticals Inc et al. v. U.S. Food and Drug Administration et al., 1:15-cv-07055 (S.D.N.Y.) (counsel for amicus curiae Medical Information Working Group);
  • Amarin Pharma Inc. et al. v. U.S. Food and Drug Administration et al., 1:15-cv-03588 (S.D.N.Y. 2012) (counsel for amicus curiae Medical Information Working Group);
  • 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); and
  • Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010) (counsel for amicus curiae Washington Legal Foundation).

• 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 of lawfully marketed products and about investigational products;
• Handling FDA dispute resolution proceedings on behalf of manufacturers adversely affected by refusal-to-file and complete response actions for innovative/orphan biopharmaceutical products;
• Assessing manufacturer processes for internal approval of medical and marketing materials; 
• Representing manufacturers in addressing OPDP regulatory letters, inquiries and advisory comment proceedings and advising on promotional issues for brands across therapeutic areas; and
• Representing innovator clients in Hatch-Waxman and other market access matters involving complex-formulation products and drugs with unique risks.

Coleen was a lead attorney on Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), a high-profile pro bono case filed against the FDA on behalf of death row prisoners from Arizona, California and Tennessee over the importation into the United States of a misbranded and unapproved lethal injection drug, sodium thiopental. Coleen has also represented the Skin Cancer Foundation and the Spina Bifida Association.

• Coleen is a member of the firm’s Executive Committee.
• Coleen is a member of the Washington Legal Foundation’s Legal Policy Advisory Board. 
• She also is past chair of the Food and Drug Committee of the American Bar Association’s Section on Administrative Law and Agency Practice.
• Coleen formerly served on the Center for Communications Compliance Advisory Board. Her memberships include the FDA Alumni Association, Drug Information Association (DIA), and the Food and Drug Law Institute (FDLI).