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Carrie Harney is an associate in the firm’s food and drug practice group. She represents companies and associations in the pharmaceutical, medical device, food, and dietary supplement industries. Ms. Harney has provided regulatory advice to clients on matters related to product labeling, pharmaceutical promotion, bioequivalence, drug importation, health claims and other nutrition-related claims, and food additives. In addition, Ms. Harney has experience in matters pertaining to the regulation of over-the-counter drugs and controlled substances. On behalf of individual clients and trade associations, Ms. Harney has submitted to FDA and other federal agencies Citizen Petitions, petitions for relief with respect to liquidated damages assessed by Customs, and comments on federal reports.
Representative Matters
- Advise dietary supplement clients on regulatory issues related to ingredients and product labeling.
- Review training materials for a major pharmaceutical company’s sales force for compliance with FDA regulatory and other legal requirements.
- Prepared a citizen petition to the Food and Drug Administration regarding the showing of bioequivalence that should be required of generic applicants referencing our client’s drug product.
- Assisted in a successful mandamus proceeding brought in New York Supreme Court on behalf of a major pharmaceutical company against state agency officials to annul an administrative determination that certain promotional activities would violate state law.
Pro Bono
- Co-counsel in a successful lawsuit against the U.S. Small Business Administration for unreasonable delay in implementing the Women’s Procurement Program.
- Advised a victim of Hurricane Katrina on insurance-related matters, which resulted in a substantial monetary recovery for the client.
Publications and Speeches
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