Krista Carver

Krista Hessler Carver

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Covington & Burling LLP
One CityCenter
850 Tenth Street, NW
Washington, DC 20001-4956
Tel: +1 202 662 5197
Fax: +1 202 778 5197




  • Harvard Law School, J.D., 2006
    • magna cum laude
    • Harvard Journal of Law and Technology, Submissions Committee
  • College of William and Mary, B.S., 2003
    • summa cum laude
    • B.S. in Chemistry
    • Phi Beta Kappa

Bar Admissions

  • District of Columbia
  • Virginia

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.

Representative Matters

  • 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.
  • Provided strategic regulatory law support to appellate litigation team in preparing amicus brief on behalf of the Pharmaceutical Research and Manufacturers of America in Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell, No. 15-5021 (D.C. Cir. 2015), an appeal concerning the proper interpretation of section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • 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.

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, Council Member and Chair, Biotechnology Law Committee

Publications and Speeches

  • "Biosimilars Boot Camp for the Paragraph IV Litigation," American Conference Institute’s (ACI’s) industry-acclaimed Paragraph IV Disputes Master Symposium (10/2/2015)
  • "Potential Impacts of Regulatory Changes," BIO IP & Diagnostics Symposium (9/18/2015)
  • "Amgen v. Sandoz: What Now?," IPO IP Chat Channel Webinar (9/2/2015)
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