Deborah M. Shelton is Leader of the Food & Drug Law Practice at McCarter & English LLP.
Deborah provides clients with deep industry-relevant expertise in biopharmaceuticals, informed by a strategic, rigorous, and pragmatic approach to client counseling gained from 20 years of serving in diverse settings, including in key external and corporate counsel roles. She counsels clients navigating complex regulations that affect business planning, product development and approval, post-market compliance, life-cycle management, due diligence and contracting, litigation strategy, and legislative and regulatory advocacy.
Deborah has represented clients before the FDA, DEA, and CMS, as well as state and federal legislative bodies. She has nearly two decades of experience with Hatch-Waxman matters and regulatory exclusivities (including under the BPCIA, new chemical entity, orphan drug, and pediatric), a subject on which she has taught numerous courses for various organizations, including the Food & Drug Law Institute (FDLI). She works with clients from the investigational and approval stages through regulatory and post-marketing compliance.
Deborah has been an industry leader in the development of the legislative biosimilar pathway and FDA’s ongoing implementation. She comes to McCarter & English from her role as Deputy General Counsel for Healthcare at BIO, the world's largest biotech trade association. She joined BIO from a global biotechnology company, where she was lead U.S. counsel to the company's Global Biosimilars Legislative and Regulatory Policy teams and the State Government Affairs team. Her leadership played a key role in shaping advocacy and response to the legal and regulatory challenges arising under the Affordable Care Act.
Prior to her work as corporate counsel, Deborah was a partner in the FDA practice of a Global 100 firm. During her years in private practice, Deborah provided regulatory counseling across FDA-regulated industries, including biopharmaceuticals, medical devices, food, dietary supplements, and cosmetics.
Deborah is a member of the advisory board for BNA's Pharmaceutical Law & Industry Report. She was lead editor of FDLI's Compilation of FDCA-Related Food and Drug Laws (2010) and the FDCA Statutory Supplement (2011), and has published and spoken extensively over the years on a wide array of issues of interest to the biopharmaceutical and other FDA-regulated industries.