Krista Hessler Carver has a wide-ranging practice that includes FDA regulatory, transactional, and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries. 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; regulatory issues related to companion diagnostics and personalized medicine; regulation of aesthetic medical devices and cosmetic appliances; 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, medical device regulation, and personalized medicine. 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 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.
- Represent numerous biotechnology innovators regarding the BPCIA and FDA implementation of the biosimilars pathway.
- On behalf of a trade association, prepared comments on FDA’s proposal to release masked and de-identified data in medical product applications.
- Prepared white paper describing factors that international regulators should consider in evaluating biosimilar versions of client’s innovative product.
- On behalf of Auxilium Pharmaceuticals, prepared successful citizen petition regarding necessary testing for generic versions of Testim.
- Advise clients regarding regulatory and legislative developments on personalized medicine and related life cycle management and legislative strategies for biologics, drugs, and diagnostics.
- Advise clients on all stages of medical device development and marketing, including pathways to market, clinical trial regulation, premarket submissions, FDA clearance or approval, advertising and promotion, postmarket reporting obligations, and recalls.
- Representation of Genzyme Corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility.
Memberships and Affiliations
- Food & Drug Law Journal, Editorial Advisory Board, Member (2008-2013), Chair (April 2012-April 2013)
- ABA Science and Technology Law Section, Council Member and Chair, Biotechnology Law Committee
Publications and Speeches