Krista Hessler Carver is a senior associate in the firm’s Food and Drug Practice Group. Ms. Carver has a wide-ranging practice that includes FDA regulatory, compliance, transactional, and legislative matters for companies in the biotechnology, pharmaceutical, medical device, and cosmetic industries. She has deep experience with issues related to devices, biologics, and biosimilars. With respect to biosimilars, Ms. Carver 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. She also counsels clients on international regulation of biosimilars and life cycle management strategies for innovative biologics. 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 has worked with many firm clients on issues relating to implementation of the scheme. 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.
Ms. Carver also has particular experience with legal and regulatory issues related to personalized medicine (including companion diagnostics), clinical trial data confidentiality, medical devices, orphan drug exclusivity, and appeals within FDA.
Ms. Carver writes and speaks regularly on subjects such as biosimilars, medical device regulation, and personalized medicine, and she is 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
- "FDA Regulation of the New Drug Development & Approval Process," Seton Hall Law Healthcare Compliance Certification Program (10/16/2013)
- "Key Regulatory Guidelines for the Development of Biologics in the United States and Europe," Biological Drug Products: Development and Strategies (Wei Wang & Manmohan Singh (eds.)), 75-109. (October 2013), Co-Author
- "Biosimilars and the BPCI Act: Where Are We Now and Where Are We Going?," CLE Webinar sponsored by the ABA Section of Science & Technology Law and ABA Section of Intellectual Property Law (9/19/2013)