Jennifer Bragg, a nationally recognized FDA lawyer, advises life sciences companies and their boards on complex legal and regulatory challenges, government investigations, and related litigation.

Jennifer draws on more than two decades of experience, including as Associate Chief Counsel for Enforcement in the FDA’s Office of Chief Counsel. She helps senior leaders and boards of directors develop strategies to resolve business-critical commercial and enforcement challenges related to:

  • US Department of Justice (DOJ) and state attorney general investigations
  • FDA and US Drug Enforcement Administration (DEA) enforcement actions
  • Internal investigations
  • Complex commercial and regulatory issues, often in the context of broader litigation and strategic transactions 

Jennifer also counsels boards and compliance departments on corporate compliance program development and other protective measures designed to mitigate risk.

While at the FDA, Jennifer advised its Office of Criminal Investigations, where she tried to verdict four criminal jury cases involving violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal statutes. She was designated by the DOJ to serve as a special assistant US attorney in ongoing criminal investigations under the FDCA, and served as the FDA Office of Chief Counsel’s primary liaison with the Office of Criminal Investigations relating to policy issues.

A recognized thought leader, she frequently speaks at leading industry conferences, including for the Food and Drug Law Institute, Medical Device Manufacturers Association, AdvaMed, International Association of Defense Counsel, and DRI. 

Jennifer’s recent experience includes representing:

Litigation/Investigations

  • A pharmaceutical company in successfully resolving a DOJ investigation of its patient affordability programs through securing a declination
  • A pharmaceutical company in successfully resolving enforcement proceedings brought by the FDA and the DOJ manufacturing issues
  • Purdue Pharma in successfully resolving DOJ civil and criminal investigations*
  • Pfizer in securing an order to vacate an amended consent decree entered into with the FDA and DOJ*
  • Miraca Holdings in securing the dismissal of claims brought by a qui tam relator under the federal False Claims Act and the California and North Carolina state analogues*
  • A leading medical device company’s senior executive in securing a dismissal after being individually named in a consent decree of permanent injunction for the company with the FDA and the DOJ Civil Division’s Consumer Protection Branch*
  • CTD Holdings in Freedom of Information Act litigation against the US, securing a settlement and attorneys’ fees*

Regulatory

  • A pharmaceutical company in connection with strategic regulatory and litigation issues associated with a competing product’s orphan exclusivity*
  • A major medical system in connection with a voluntary self-disclosure regarding financial relationships with secondary care facilities*
  • A biopharmaceutical company in connection with a request to the FDA to change the determination to permanently bar a former FDA employee that the company subsequently employed from participating in matters involving the company’s nondisclosure agreement*
  • 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 appealing an FDA decision to reject the company’s flagship medical device for marketing in the US; secured an FDA revers al decision clearing the product for sale*

Compliance/Internal Investigations

  • A board special committee in connection with an internal investigation of various whistleblower allegations
  • A life sciences company in connection with an internal investigation relating to data breach issues
  • A life sciences company in connection with an internal investigation relating to the adequacy of its compliance program
  • A pharmaceutical company in its response to an FDA Form 483 
  • A tobacco company in its response to an FDA Warning Letter
  • A pharmaceutical company in connection with an audit of its drug pricing compliance
  • A life sciences company in connection with an internal investigation relating to its patient support program
  • A charitable foundation in developing compliance training for patient support programs

*Matter handled prior to joining Latham 

Bar Qualification

  • District of Columbia
  • Maryland

Education

  • JD, University of Maryland School of Law, 1996
    with honors
  • BA, University of Maryland, 1993
    cum laude