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.
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, Incoming Chair
· ABA Science and Technology Law Section, Biotechnology Law Committee Co-Chair
Publications
· "FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications," Covington E-Alert (2/7/2012), Co-Author
· "An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009," Food and Drug Law Journal (With permission from FDLI) (12/6/2010), Co-Author
· "Companion Diagnostics: Evolving FDA Regulation and Issues for Resolution," In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI ) (2010), Author
· "A Global View of the First Amendment Constraints on FDA," Food and Drug Law Journal (2008), Author
· "Follow-on Biologics V. Hatch-Waxman: What the FOB Market Might Look Like," Regulatory Affairs Focus (Reprinted with Permission From Regulatory Affairs Professionals Society (RAPS) (January 2008), Co-Author
· "FDA Regulation of Biological Products," chapter 5 in The Pharmaceutical Regulatory Process (2nd ed.) (2008), Co-Author
· "The Proton Affinity of Lysine Homologues from the Extended Kinetic Method," Journal of Physical Chemistry A (2004), Co-Author
Presentations and Speeches
· "Ongoing Changes to the 510(k) Program: FDA Draft Guidance on Substantial Equivalence in Premarket Notifications," Thompson Interactive Webinar (3/22/2012)
· "Regulatory Updates - Three Key Areas," Personalized Diagnostics Core Program of the Molecular Med Tri-Con (2/22/2012)
· "Patent Implications of Health Care Legislation," ALI-ABA Topical Course Webcast (6/29/2011)
· "Navigating the U.S. Biosimilar Pathway," Webcast sponsored by the ABA Section of Science & Technology Law, ABA Section of Intellectual Property Law, and ABA Center for CLE (6/29/2010)
· "Introduction to the Biologics Price Competition and Innovation Act of 2009 (BPCIA)," New Jersey Corporate Counsel Association (5/13/2010)
· "Follow-On Biologics: A New Legislative Framework," RAPS NY/NJ Local Chapter (3/13/2008)