An experienced regulatory and litigation attorney, Jennifer Bragg advises FDA-regulated companies, as well as hospitals and health care systems, facing government investigations and U.S. Food and Drug Administration (FDA) enforcement challenges.
Ms. Bragg 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.
She conducts due diligence and related counseling in connection with transactions in the life sciences and health care industries. Additionally, Ms. Bragg has extensive litigation and trial experience.
Her work often involves developing strategies to help companies resolve regulatory issues to minimize litigation and enforcement risks, as well as overcome transactional hurdles. Ms. Bragg’s recent representations include, among others:
- DENTSPLY International, Inc. in a federal civil False Claims Act case pursued by a qui tam relator involving allegations involving improper marketing and promotion of dental products;
- Veloxis Pharmaceuticals A/S as plaintiffs in filing a federal action against the Food and Drug Administration to reverse the FDA’s decision to delay approval of Veloxis’ new drug Envarsus XR based on marketing exclusivity given to an earlier-approved competing drug;
- a biopharmaceutical company in advising senior management and the board of directors on the development and implementation of a comprehensive corporate compliance program;
- HealthSpring Inc. in connection with the federal and state regulatory aspects of its $3.8 billion acquisition by CIGNA Corporation;
- Human Genome Sciences, Inc. in connection with the regulatory aspects of its initially unsolicited, but subsequently agreed upon, $3.6 billion acquisition by GlaxoSmithKline plc;
- an international medical device company in successfully persuading the FDA to issue an export certificate, despite ongoing FDA inspection issues;
- Terumo Cardiovascular Systems Corporation in enforcement proceedings by the DOJ and FDA in connection with the company’s manufacturing practices.
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 also was designated by the DOJ to serve as a special assistant U.S. 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.
In addition to her thriving practice, Ms. Bragg is a member of the firm’s Women’s Initiatives Committee, which is designed to promote the retention and advancement of women in the firm. She also is a co-chair of the firm’s hiring committee.
- J.D., University of Maryland School of Law, 1996 (with honors)
- B.A., University of Maryland, 1993
- District of Columbia
- Maryland District Court
- U.S. District Court for the District of Columbia
Associations : Member, Medical Devices Committee, The Food and Drug Law Institute
Rate : $$$