An experienced regulatory and litigation attorney, Jennifer L Bragg advises FDA-regulated companies, as well as hospitals and healthcare systems, facing government investigations and US Food and Drug Administration (FDA) enforcement challenges. She frequently represents pharmaceutical, medical device and food companies in crisis management situations related to products that have manufacturing or quality issues, helping them navigate the myriad of matters that arise in the context of product recalls, and also counsels on compliance, advertising and promotion issues. Additionally, Ms Bragg conducts due diligence and related counseling in connection with transactions in the life sciences and healthcare industries.
Her work often involves developing strategies to help companies resolve regulatory issues to minimise litigation and enforcement risks, as well as overcome transactional hurdles.
From 1998 to 2003, Ms Bragg served in the FDA’s Office of Chief Counsel as associate chief counsel for enforcement, where she provided advice to the FDA’s Office of Criminal Investigations. During that time, she tried to verdict four criminal jury trials involving violations of the Federal Food, Drug and Cosmetic Act (FDCA) and other federal statutes. Her matters involved compounding pharmacies, unapproved pharmaceuticals, controlled substances, misbranded devices and food-related good manufacturing practices (GMP). She was also designated by the DOJ to serve as a special assistant US attorney in various districts throughout the country regarding ongoing criminal investigations under the FDCA. Additionally, Ms Bragg served as the FDA Office of Chief Counsel’s primary liaison with the Office of Criminal Investigations relating to policy issues.