Jayne Bultena Joins Bergeson & Campbell, P.C. and Brings Valuable Experience to Its FDA Practice

Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Jayne Bultena has joined B&C as Of Counsel. Ms. Bultena brings a distinguished background on a wide range of matters arising under the Federal Food, Drug, and Cosmetic Act. She has represented Fortune 100 companies, start-ups, and venture capital investors on several issues, including developing and implementing life-cycle management strategies using patent and non-patent (Hatch-Waxman) options, including seeking orphan drug designations; switching drug products from prescription to non-prescription status by creating novel marketing plans to address policy and regulatory concerns and preparing clients for advisory committee presentations; managing compliance risks and promotional violations, including U.S. Food and Drug Administration (FDA) inspections; responding to FDA deficiencies and warning letters; advising clients on development of claims, labeling, and promotional materials; petitioning FDA on changes in patent restoration terms, barring use of volunteers for certain clinical testing, supporting regulation of tobacco products, and clarifying orphan drug designations; and assisted clients with unique food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways. In addition to representing clients before FDA, Ms. Bultena has represented clients before the Consumer Product Safety Commission and the Federal Trade Commission.

Ms. Bultena received her bachelor’s degree from the University of South Dakota, magna cum laude, and her law degree from Harvard University. Most recently, Ms. Bultena was a partner in the Washington, D.C. office of Foley Hoag LLP.