Jennifer is a partner who joined the firm in 1999. Focusing her practice on representing clients of all sizes, Jennifer excels at finding the most efficient ways to navigate the intricate regulations set in place by the FDA, the FTC, and related State and Federal agencies.
Jennifer’s clients in the pharmaceutical, dietary supplement, medical device, and cosmetic industries turn to her to help them create and execute a comprehensive plan to ensure their companies stay in compliance with a variety of legal and regulatory requirements.
She has counseled pharmaceutical clients on a wide variety of matters related to life-cycle management, exclusivity questions, promotional and marketing practices, other post-approval requirements, user fees, and issues arising under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, as well as those introduced by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Food and Drug Administration Amendments Act of 2007. She also spends a great deal of time assisting clients in presenting complex issues to the FDA via the agency’s Citizen Petition procedures as well as representing industries in registration and scheduling proceedings before the Drug Enforcement Administration (DEA).
Jennifer also ensures her clients are counseled on all aspects of promoting and marketing dietary supplements, OTC drug products, cosmetics, and medical devices, including product labeling. In addition to this, Jennifer has a deep understanding of the rules and regulations surrounding dietary supplements and she frequently advises them on the requirements of the Dietary Supplement Health and Education Act of 1994 and the FDA’s implementing regulations, including product labeling, determining whether a product satisfies the definition of a dietary supplement, evaluating whether a new dietary ingredient notification is required, and identifying the types of claims that may be made in labeling and advertising.
Clients also know they can count on Jennifer to represent and advise them on a range of issues related to the development of advertising and labeling claims, including the adequacy of substantiation, the express and implied claims conveyed by promotional messages, and the evaluation of consumer perception surveys. She has worked closely with her clients in defending and initiating challenges against competitors’ labeling and marketing practices before the FDA, and before the National Advertising Division of the Council of Better Business Bureaus, Inc., and related entities, such as the Electronic Retailing Self-Regulation Program. Jennifer has also assisted clients in obtaining appropriate network clearance to air advertising on television as well as conducting civil litigation against the FDA on behalf of regulated industries.
Prior to joining Kleinfeld, Kaplan, and Becker, Jennifer practiced in the Washington D.C. office of a large, international law firm, specializing in civil litigation.