Erica Jackson is a partner in the firm’s Research Triangle Park, NC and Charleston, SC offices and a member of the Food, Drugs, Medical Devices and Cosmetics and Health Care practice groups. Her practice focuses on Food and Drug Administration (FDA) regulatory matters, providing strategic counsel to pharmaceutical, medical device, biologic, dietary supplement, and food manufacturers, as well as other related health care entities. In addition, she advises clients on health care fraud and abuse compliance and matters involving the Centers for Disease Control and Prevention (CDC), Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Agriculture (USDA), and similar state regulatory agencies.
Prior to joining the firm, Ms. Jackson was a corporate counsel for Genentech, Inc., where she advised development, medical affairs, sales/marketing, manufacturing, safety, and government affairs business teams on FDA and health care regulatory matters involving pipeline molecules and approved products in the infectious disease, rare disease, neurology, and oncology areas. In addition, she was an associate in the Washington, D.C. office of an international law firm, where she concentrated her practice on FDA and health care matters.
Her FDA regulatory and enforcement experience includes representing clients on global clinical trial matters, regulatory pathway assessments, product label negotiations, company promotional review committees, advertising and marketing tactics, FDA and foreign health authority inspections and responses, and Corporate Integrity Agreement and Consent Decree implementation.
Her health care fraud and abuse experience includes representing clients in government and internal investigations, developing compliance policies/trainings, and advising on risk mitigation strategies.
Her transactional experience includes conducting regulatory due diligence for buyers and sellers of FDA- and USDA-regulated products; drafting, negotiating and reviewing clinical trial, data sharing, government purchasing, and related agreements; and counseling on contract disputes.
Articles in the National Law Review database by Erica M. Jackson