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.
About Bergeson & Campbell, P.C. -- Located in Washington, D.C., B&C is a law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical product regulation and approval matters, medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. Clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; pharmaceuticals, medical devices, and diagnostic products; fibers; paints and coatings; printing and publishing; and plastic products. Additional information is available at www.lawbc.com.
About B&C Consortia Management, L.L.C. -- BCCM, an affiliate of B&C, has strong institutional experience in consortia management. BCCM provides cost effective administrative and management services to consortia to ensure their interests are protected and their voices heard on issues of concern. BCCM works with industry groups to develop or expand advocacy and/or product stewardship programs, to develop and conduct communications outreach to local, state, federal, or international government entities, to formulate and initiate research programs -- whether voluntary or in response to regulatory requirements, and many other activities. Additional information is available at www.bc-cm.com.
About The Acta Group, L.L.C. and The Acta Group EU, Ltd -- The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) are consulting affiliates of B&C, established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market agricultural and industrial chemicals, products of biotechnology and nanotechnology, and Food and Drug Administration-regulated products. Acta and Acta EU manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry. Additional information is available at www.actagroup.com.