Krista Hessler Carver

Krista Carver is a co-chair of Covington’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her nearly 15 years of experience, she provides strategic and practical advice to clients on an array of FDA regulatory issues. Her areas of focus include biosimilars, orphan drug, and Hatch-Waxman regulatory issues; digital health; gene therapies; pediatric testing; regulatory exclusivities and life cycle management strategies; risk evaluation and mitigation strategies (REMS); pharmacovigilance; and issues regarding medical products for COVID-19, including emergency use authorizations. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions. She also maintains an active policy practice, addressing legislative issues surrounding 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) and the United States Chapter in the Life Sciences Law Review.