Krista Hessler Carver focuses on FDA regulatory and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries and related transactional matters. She has particular experience with biosimilars issues. She assisted biotechnology innovators in legislative matters leading up to enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and now represents clients in connection with FDA interpretation and implementation of the BPCIA.
Ms. Carver also counsels clients on an array of regulatory issues including orphan drug, Hatch-Waxman, and pediatric exclusivities and life cycle management strategies; priority review vouchers; breakthrough and fast track status; product jurisdiction; human cells, tissues, and cellular and tissue-based products (HCT/Ps); clinical trial data confidentiality and transparency; proprietary naming of pharmaceuticals; and medical device and diagnostic regulation. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions, and with legislative issues surrounding potential amendments to the Federal Food, Drug, and Cosmetic Act and related laws.
Ms. Carver writes and speaks regularly on subjects such as biosimilars and life sciences legislation. She co-authored a comprehensive article on the BPCIA, “An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009” (Food and Drug Law Journal, 2010). Ms. Carver is former chair of the Biotechnology Law Committee of the ABA Section of Science and Technology Law and a member of the Section Council. She also serves as Co-Editor-in-Chief of Covington’s InsideMedicalDevices blog.