Jennifer L. Bragg
Health Care Enforcement and Regulation
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. 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 health care industries.
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:
- a biomedical research company in connection with various FDA regulatory and compliance issues;
- a biopharmaceutical company in advising senior management and the board of directors on the development and implementation of a comprehensive corporate compliance program;
- a multinational food company in connection with the recall of millions of units of a nonalcoholic beverage caused by defective glass bottles. In addition to successfully managing the recall with the FDA, Ms. Bragg favorably negotiated an indemnification agreement with the bottle supplier on behalf of the company;
- 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;
- an international medical device company in the appeal of a decision by the FDA to reject the company’s flagship medical device for marketing in the United States. Ms. Bragg convinced the FDA to reverse its decision and approve the product for sale;
- an international medical device manufacturer in providing strategic regulatory and litigation advice in connection with adverse event reporting issues;
- a medical device company and an individual defendant in negotiating a consent decree with the FDA;
- an international pharmaceutical manufacturer in providing regulatory guidance in connection with the company’s preparations to launch a new drug in the United States;
- a pharmaceutical company and a medical device company in connection with a U.S. Department of Justice (DOJ) criminal and civil investigation; and
- 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.
Ms. Bragg was selected for inclusion in Chambers USA: America’s Leading Lawyers for Business 2014; The Best Lawyers in America 2013-2015; and Legal 500 U.S. 2014. She co-chairs the annual Enforcement Conference for the Food and Drug Law Institute, and has spoken on enforcement and litigation issues at numerous conferences across the United States.
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.
J.D., University of Maryland School of Law, 1996 (with honors)
B.A., University of Maryland, 1993
Law Clerk, Hon. William W. Wenner, Court of Special Appeals of Maryland
Member, Medical Devices Committee, The Food and Drug Law Institute
Associate Chief Counsel, U.S. Food and Drug Administration (1998-2003)