Krista Hessler Carver

Krista Hessler Carver is an associate in the firm’s Food and Drug Practice Group.  She advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters.  Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products, and personalized medicine.

Ms. Carver writes and speaks regularly on subjects such as medical device regulation, biosimilars, and personalized medicine, and she is Co-Editor-in-Chief of Covington’s InsideMedicalDevices blog.

Representative Matters

• Assisted biotechnology innovators in legislative matters leading up to enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Represent clients in connection with FDA interpretation and implementation of the BPCIA.
• 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.  Conduct regulatory due diligence for device transactions.
• Representation of Genzyme Corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility.
• 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.  Drafted comments on FDA draft companion diagnostic guidance on behalf of a major pharmaceutical company.
• Counsel clients on product jurisdictional issues, including distinctions between devices, drugs, cosmetics, and combination products.  Assist clients in preparing requests for designation for novel products.
• Representation of major pharmaceutical company in Justice Department investigation concerning company’s interactions with physicians and investigators.

Pro Bono

• Assisted nonprofit organization with federal legislative efforts related to pharmacy compounding.

Memberships and Affiliations

• Food & Drug Law Journal, Editorial Advisory Board, Chair
• ABA Science and Technology Law Section, Biotechnology Law Committee, Chair

Publications and Speeches

• "D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"," Covington E-Alert (4/26/2013), Co-Author
• "Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion," Covington E-Alert (12/7/2012), Co-Author
• "Ongoing Changes to the 510(k) Program: FDA Draft Guidance on Substantial Equivalence in Premarket Notifications," Thompson Interactive Webinar (3/22/2012)