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Krista Hessler Carver

Partner

Washington +1 202 662 5197

  • About
  • Representative Matters
  • Credentials
  • About

    Krista Carver co-chairs Covington's global Food, Drug, and Device Practice Group and the firm's Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her more than 18 years of experience at the firm, she provides strategic and practical advice to clients on an array of FDA regulatory issues, including those that intersect with other areas such as healthcare. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution and citizen petitions, and maintains an active policy practice addressing legislative issues surrounding amendments to the Federal Food, Drug, and Cosmetic Act and related laws. Chambers USA reports that Krista “is a brilliant lawyer with deep technical expertise that she is able to boil down clearly and succinctly," and that she “is incredibly impressive in biosimilars issues and biologics," per Chambers sources. Krista co-chairs Covington's IRA Task Force.

    Krista’s areas of focus include:

    • Inflation Reduction Act;
    • Biosimilars;
    • Hatch-Waxman regulatory issues;
    • Orphan-drug designation and exclusivity matters;
    • Pediatric Research Equity Act and Best Pharmaceuticals for Children Act;
    • Digital health;
    • Gene therapies and human cellular, tissue, and cellular- and tissue-based products;
    • Risk evaluation and mitigation strategies (REMS), pharmacovigilance, postmarketing study requirements; and the CREATES Act; and
    • Clinical trial and submission issues including real-world evidence, decentralized clinical trials, and diversity in clinical trials.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Outside counsel to PhRMA on FDA regulatory aspects of the FDA Reauthorization Act of 2017 and the 21st Century Cures Act. Advises PhRMA on a range of regulatory and legislative matters including with respect to biosimilars, orphan drugs, pediatric testing and exclusivity, REMS, and Hatch-Waxman issues.
    • Counsel clients on the “Drug Price Negotiation Program” elements of the Inflation Reduction Act, including preparation of manufacturer data submissions, discussions with CMS, effects of the IRA on life cycle planning (including with respect to orphan drugs and drugs with anticipated biosimilar or generic competition), and litigation strategies.
    • Advise numerous innovators on implementation of the Biologics Price Competition and Innovation Act, nonproprietary naming, labeling, and interchangeability of biologics, and FDA’s implementation of the Act’s reference product exclusivity provisions.
    • Represented numerous clients with formal dispute resolution or similar submissions to FDA, including successful dispute resolutions regarding eligibility for pediatric exclusivity; clinical trial design issues; and a proposed proprietary name rejection. 
    • Assist clients with litigation strategies to challenge FDA actions, including assessment of the implications of Loper Bright for possible litigation.
    • Successfully represent multiple clients in challenging denial of orphan-drug designation and securing various types of statutory exclusivities.
    • Prepare requests for designation and advise clients on jurisdictional issues for drugs, biologics, and combination products.
    • Served as international expert in the areas of regulatory data protection and patent linkage as part of a series of workshops hosted by the Tsinghua University Law School to inform efforts to revise the Drug Administration Law in China.
    • Advise clients on gene therapy products, including issues regarding orphan-drug exclusivity, risk evaluation and mitigation strategies, preapproval communications, informed consent and clinical trial issues, and the site certification process.
    • Develop citizen petitions for innovative companies regarding safety testing standards, labeling issues, and therapeutic equivalence determinations for generic and section 505(b)(2) applications. For example, on behalf of Auxilium Pharmaceuticals, prepared successful citizen petition regarding necessary testing for generic versions of Testim.
    • Advise clients on a range of drug development issues, including clinical trials, drug naming, FDA’s filing review, major amendments, and advisory committee preparation.

    Areas of Expertise

  • Credentials
    Education
    • 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
    Accolades
    • Chambers USA
      • Life Sciences: Regulatory/Compliance (USA - Nationwide) (Band 2) and Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia) (Band 2) (2025)
      • Life Sciences: Regulatory/Compliance (USA - Nationwide) (Band 3) and Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia) (Band 3) (2024)
      • Life Sciences: Regulatory/Compliance (USA - Nationwide) (Band 3) and Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia) (Band 4) (2023)
      • Healthcare: Pharmaceutical/Medical Products Regulatory (DC) (Band 4); "Up and Coming" Life Sciences: Regulatory/Compliance (USA - Nationwide) (2022)
      • "Up and Coming" - Life Sciences: Regulatory/Compliance (USA - Nationwide) and Healthcare: Pharmaceutical/Medical Products Regulatory (DC) (2021)
      • "Up and Coming" - Healthcare: Pharmaceutical/Medical Products Regulatory (DC) (2020)
    • Chambers Global, Life Sciences: Regulatory/Compliance Band 3 (2024-2025); "Up and Coming" (2021-2023)
    • The Best Lawyers in America, FDA Law (2018-2022)
    • Washington DC Super Lawyers, Food and Drug "Rising Star" (2016-2020) 
    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, Past Member
    • ABA Science and Technology Law Section, Former Council Member and Former Chair, Biotechnology Law Committee

    Areas of Expertise

News and Insights

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