Jennifer Bragg is a nationally recognized lawyer advising Food and Drug Administration (FDA)-regulated companies facing government investigations and related enforcement challenges.

Bio

Since serving in the FDA’s Office of Chief Counsel as associate chief counsel for enforcement, Ms. Bragg regularly represents companies in criminal and civil litigation and strategic regulatory matters. She is frequently called upon to conduct due diligence and related counseling in connection with transactions in the life sciences and health care industries, and has extensive litigation and trial experience.

Ms. Bragg’s primary practice involves advising pharmaceutical and medical device companies in connection with complex regulatory issues in an effort to minimize litigation and enforcement risks, as well as overcome transactional hurdles. Her recent representations include, among others:

Litigation/Investigations

  • DENTSPLY International, Inc. in a federal civil False Claims Act case pursued by a qui tam relator regarding allegations involving improper marketing and promotion of dental products;
  • Veloxis Pharmaceuticals A/S as plaintiffs in filing a federal action against the FDA to reverse its decision to delay approval of Veloxis’ new drug Envarsus XR based on marketing exclusivity given to an earlier-approved competing drug;
  • a global pharmaceutical company in connection with an internal investigation into allegations that various device quality system regulations were not being followed;
  • a global medical device company in connection with an internal investigation into allegations that recalls and complaints were not being evaluated in accordance with FDA regulations;
  • a global cosmetics company in connection with a DOJ investigation into its commercial and import operations;
  • a medical device company and an individual defendant in negotiating a consent decree with the FDA;
  • a pharmaceutical company in connection with filing a citizen petition response;
  • a pharmaceutical company and a medical device company in connection with a DOJ criminal and civil investigation;
  • Terumo Cardiovascular Systems Corporation in enforcement proceedings by the DOJ and FDA in connection with the company’s manufacturing practices;
  • a pharmaceutical company in connection with multiple U.S. Department of Justice (DOJ) and state attorneys general investigations into its marketing practices and parallel congressional investigations; and
  • CTD Holdings in FOIA litigation against the United States, securing a settlement and attorneys fees.

Regulation

  • a biopharmaceutical company in connection with a request to the FDA to change the determination to permanently bar a former FDA employee subsequently employed by the pharmaceutical company from participating in matters involving the company’s non-disclosure agreement;
  • multiple pharmaceutical companies in connection with providing strategic regulatory advice for reimbursement support activities;
  • 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; a biomedical research company in connection with various FDA regulatory and compliance issues;
  • a biopharmaceutical company in advising its senior management and board of directors on the development and implementation of a comprehensive corporate compliance program;
  • 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 clear the product for sale;
  • an international medical device manufacturer in providing strategic regulatory and litigation advice in connection with adverse event reporting issues; and
  • an international pharmaceutical manufacturer in providing regulatory guidance in connection with the company’s preparations to launch a new drug in the United States,

Mergers and Acquisitions

  • 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;
  • JAB in its acquisition of Compassion-First Pet Hospitals at a total enterprise value of $1.2 billion;
  • Amicus Therapeutics, Inc. in its acquisition of Celenex, Inc.;
  • Otsuka Pharmaceutical Co., Ltd. in its acquisition of Visterra, Inc.;
  • Keurig Green Mountain in its merger with Dr Pepper Snapple Group, Inc.;
  • BioCryst Pharmaceuticals, Inc. in its merger with Idera Pharmaceuticals, Inc.;
  • Juno Therapeutics, Inc. in its acquisition by Celgene Corporation;
  • Stryker Corporation in its $662 million acquisition of Entellus Medical, Inc.; and
  • HealthSpring Inc. in connection with the federal and state regulatory aspects of its $3.8 billion acquisition by CIGNA Corporation.

From 1998 to 2003, as the FDA’s associate chief counsel, she advised its 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. 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, she is a frequent speaker at leading industry conferences, including the FDLI, AdvaMed and DRI. Ms. Bragg is a proud member of Skadden’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. Ms. Bragg serves as chair of the board of directors of the Food and Drug Law Institute. She also has authored articles related to health care investigation trends, enforcement, the FDA and DOJ.

Ms. Bragg has repeatedly been selected for inclusion in Chambers USA: America’s Leading Lawyers for Business, where she is described as “superlative, timely and effective” with “a great understanding of regulatory issues and ... an incredibly valued member of the team.” In addition, she has been named in The Best Lawyers in America every year since 2013. She also was included in The Legal 500 U.S., Lawdragon 500 Leading Lawyers in America, and named as a Life Sciences Star in n LMG Life Sciences’ and a Regulatory Star in its 2016 rankings. Ms. Bragg was named as an Expert in the 2019 edition of Who’s Who Legal: Life Sciences’ Regulatory chapter.

Credentials

Education

  • J.D., University of Maryland School of Law, 1996 (with honors)
  • B.A., University of Maryland, 1993

Admissions

  • District of Columbia
  • Maryland
  • Maryland District Court
  • U.S. District Court for the District of Columbia

Associations

  • Member, Medical Devices Committee, The Food and Drug Law Institute

Government Service

  • Associate Chief Counsel, U.S. Food and Drug Administration (1998-2003)

Experience

  • Law Clerk, Hon. William W. Wenner, Court of Special Appeals of Maryland

Jennifer L. Bragg

Partner, Health Care and Life Sciences
jennifer.bragg@skadden.com