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Krista Carver
Krista Hessler Carver
Washington +1 202 662 5197 Download V-card

Krista Hessler Carver focuses on FDA regulatory and legislative matters for companies in the biotechnology and pharmaceutical 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 assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions, and with legislative issues surrounding amendments to the Federal Food, Drug, and Cosmetic Act and related laws, including the recently-passed 21st Century Cures Act and FDA Reauthorization Act of 2017.

  • Outside counsel to PhRMA on FDA regulatory aspects of 21st Century Cures Act. Advises PhRMA on a range of regulatory and legislative matters including with respect to biosimilars, REMS, and Hatch-Waxman issues.
  • Represent numerous biotechnology innovators regarding the BPCIA and FDA implementation of the biosimilars pathway, including preparation of comments on FDA draft guidance and citizen petitions, drafting of requests for reference product exclusivity, and developing life cycle management strategies.
  • Advise clients on securing and transferring priority review vouchers and provide regulatory support for related transactions.
  • Develop citizen petitions for innovative companies regarding bioequivalence and other testing standards for generic drugs and related labeling requirements. For example, on behalf of Auxilium Pharmaceuticals, prepared successful citizen petition regarding necessary testing for generic versions of Testim.
  • 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)
  • Food and Drug Law Institute, Drugs and Biologics Committee, Member    
  • ABA Science and Technology Law Section, Former Council Member and Former Chair, Biotechnology Law Committee
  • The Best Lawyers in America, FDA Law (2018)
  • Washington DC Super Lawyers, Food and Drug "Rising Star" (2016-2017)