Colleen M.Heisey

With more than 20 years of experience focused on Food and Drug Administration (FDA) regulated products, Colleen Heisey has a strong understanding of the legal, regulatory, and compliance issues facing drug, biologics, medical device/diagnostic, and food/dietary supplement clients. Her practice involves strategic counsel to clients navigating near-market and post-market opportunities and obligations, including matters related to product jurisdiction, pathways to market, regulatory exclusivities, accelerated approvals, orphan drug status, adverse event reporting, recalls, and managing federal agency inquiries and enforcement actions.

A business-oriented problem solver, Colleen evaluates and advises on product advertising and promotion and has helped life sciences companies launch dozens of prescription and over-the-counter (OTC) drug and device products. She has worked with regulated industries to develop and implement right-sized comprehensive compliance programs. Colleen's distinct skills and experiences are deployed to serve clients as they perform due diligence on products and targets and negotiate license, collaboration, acquisition, and other commercial agreements. She also supports robust teams in contract disputes and arbitration arising from commercial agreements involving regulated products and in litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA).

Colleen maintains an active presence in the Food and Drug Law Institute, speaking and writing for the organization, as well as serving on planning and products committees. As a first-generation college graduate, she is a proud member of the Board of Trustees of Lycoming College.