Elizabeth Trentacost | People

Elizabeth Trentacost counsels food, life sciences, and consumer products companies on a broad range of FDA regulatory, compliance, enforcement, and strategic matters. She routinely advises on issues related to product and claims development, and provides guidance that encompasses FDA, FTC, NAD, and litigation considerations and risks. She also maintains an active pro bono practice.

Prior to joining Arnold & Porter, she spent several years as a Regulatory Counsel in the Office of Regulatory Policy in FDA's Center for Drug Evaluation and Research. At FDA, she was involved in a wide variety of policy issues involving drug approvals, responded to citizen petitions, developed guidance for industry, and counseled on matters relating to Hatch-Waxman marketing exclusivities. Previously, Ms. Trentacost worked at a law firm in Washington, DC where she focused on international trade investigations and appellate litigation.

Focus Areas

Experience

Performs regulatory due diligence on behalf of regulated companies and potential investors or purchasers in connection with commercial transactions involving food and life sciences companies.
Counsels food companies on FSMA compliance, GRAS status and food additive regulation issues, launching new products, product claims and labeling, marketing campaigns, and FDA policies and guidance.
Advises on pharmaceutical premarket and postmarket development and strategic considerations, including exclusivity, clinical trials, manufacturing and supply chain, data integrity, review pathways, and expanded access issues, and on interacting with FDA.
Reviews labeling and advertising claims for food, cosmetic, drug and device products, and provides guidance on substantiating claims and the associated risks.
Assists pharmaceutical and medical device manufacturers with promotional review matters, and serves as the legal representative on promotional review committees.

Assists companies in responding to FDA warning letters and inquiries related to product development and postmarketing study requirements.
Analyzes legislation, regulations, and guidance for industry, drafts comment letters on proposals, and advises FDA-regulated companies on the implications of these developments.
Assists pharmaceutical companies in compliance matters, including drafting policies, procedures, and training materials, and advises on interactions between commercial and medical functions.
Represents companies in advertising challenges before the National Advertising Division (NAD) of the Advertising Self-Regulatory Council.