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Krista Hessler Carver
Partner
Covington & Burling
Krista Carver is a Partner and co-chairs Covington’s Life Sciences – Pharmaceutical and Biotechnology Industry Group. Drawing on her nearly 17 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.
Recent Articles by Krista Hessler Carver
Call Off Chicken Little: The Sky is Not Falling for Skinny Labeling After GSK v. Teva
Although Professors Sean Tu and Aaron Kesselheim have advocated for legislation to respond to the Federal Circuit’s 2021 opinion in GSK v. Teva, that case did not—as they assert—“threaten[] to nullify every skinny label carveout.” Rather, the Federal Circuit applied the unremarkable principle that generic drug manufacturers are obligated to ensure that their labeling and other representations do not induce infringement of an innovator’s method-of-use patents. Consistent with this longstanding principle, generic drug manufacturers continue to pursue skinny labeling strategies. In fact, several recent court decisions have distinguished GSK and found lack of inducement by a generic applicant’s proposed labeling, showing that skinny labeling strategies have not been “nullified.”