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James Fraser is a former Associate Chief Counsel at the U.S. Food & Drug Administration. He represents and advises pharmaceutical companies, medical device companies, and other industry clients in FDA-related regulatory, compliance, and enforcement matters. He also represents pharmaceutical and medical device companies in mass tort and other product liability litigation.

In his five years at FDA (August 2016 – August 2021), James represented the agency in civil litigation and potential civil litigation throughout the United States. In so doing, he worked closely with and provided legal advice to various organizations within FDA, such as the Center for Drug Evaluation and Research (including the Office of New Drugs and the Office of Generic Drugs); the Center for Devices and Radiological Health; the Center for Biologics Evaluation and Research; the Center for Food Safety and Applied Nutrition (including the Office of Dietary Supplement Programs and the Office of Cosmetics and Colors); the Center for Veterinary Medicine; and the Center for Tobacco Products. He also worked with attorneys in the Department of Justice (including the Office of the Solicitor General and the Consumer Protection Branch).

James’ litigation work at FDA included defending the agency against Administrative Procedure Act challenges to FDA’s decisions regarding FDA-regulated products, bringing civil enforcement actions against FDA-regulated companies for violations of the Food, Drug, and Cosmetic Act (FDCA), and drafting amicus curiae and other filings advocating FDA’s positions on federal preemption and preclusion.

James also has over 12 years of private practice experience defending pharmaceutical and medical device manufacturers in products liability and mass tort litigation throughout the United States. This work has included briefing complex issues such as federal preemption, federal jurisdiction, admissibility of expert testimony under Daubert and Frye, punitive damages, and choice of law, as well as taking and defending fact and expert witness depositions.

James began his legal career in the Air Force Judge Advocate General’s (“JAG”) Corps, where he served as a trial prosecutor, trial defense counsel, and appellate counsel.

Capabilities

Experience

  • On behalf of FDA, won summary judgment or dismissal in three separate cases where generic prescription drug manufacturers sought Hatch-Waxman marketing exclusivity for their products.°
  • On behalf of FDA, won summary judgment where a biosimilar manufacturer challenged an agency interpretation of the Biologics Price Competition and Innovation Act.°
  • Served on a DOJ/FDA trial team that won a six-day trial in the Central District of California where the government obtained a permanent injunction preventing an over-the-counter drug manufacturer from selling its products.°
  • Via amicus curiae filings on behalf of FDA, won decisions from the U.S. International Trade Commission and the U.S. Court of Appeals for the Federal Circuit holding that the FDCA precluded a prescription drug manufacturer’s Lanham Act and Tariff Act claims against dietary supplement manufacturers.°
  • On behalf of FDA, won dismissal of a public interest group’s challenge to an agency decision regarding a food labeling regulation.°
  • On behalf of FDA, won dismissal of a public interest group’s challenge to an agency decision regarding a cosmetic product.°
  • On behalf of FDA, won dismissal of a consumer’s challenge to an agency decision regarding the labeling of a tobacco product.°
  • Advised FDA’s Center for Food Safety and Applied Nutrition on its submission in support of a California administrative agency’s proposed state regulation exempting coffee from California’s Proposition 65 cancer-warning requirement.°
  • Advised FDA’s Office of Dietary Supplement Programs on its response to a New Dietary Ingredient Notification.°
  • Advised FDA’s Office of New Drugs in resolving a dispute with a prescription drug manufacturer regarding requirements under a Risk Evaluation and Mitigation Strategy (“REMS”).°
  • Advised FDA’s Office of Cosmetics and Colors in responding to a Citizen Petition that requested regulatory action regarding a cosmetic product.°
  • Advised FDA’s Center for Devices and Radiological Health in responding to a Citizen Petition that requested the agency withdraw its approval of a Class III medical device.°
  • In private practice, wrote a post-trial motion that resulted in a 99.6% reduction of a $9 billion punitive damages verdict (reported to be the seventh largest punitive damages verdict in U.S. history).°
  • In private practice, has had primary responsibility for legal briefing in four federal multi-district (MDL) proceedings, two state-wide coordinated proceedings, and many other federal and state cases throughout the country.°
  • In private practice, has written briefs for cases in four federal appellate courts and four state appellate courts.°
  • In private practice, served as a member of on-site motions and/or witness preparation teams for ten multi-week jury trials (including MDL “bellwether” trials) in Minnesota, Missouri, New York, New Jersey, and Ohio.°

°The above representations were handled by Mr. Fraser prior to his joining Greenberg Traurig, LLP.

  • Associate Chief Counsel for Litigation, U.S. Food and Drug Administration – Office of the Chief Counsel, 2016-2021
  • U.S. Air Force – Judge Advocate General’s Corps, 1995-2001
    • Appellate Counsel, Air Force Appellate Counsel Division, Washington, DC, 1999-2001
    • Trial Defense Counsel, Air Force Trial Defense Division, Dover AFB, DE, 1998-1999
    • Prosecutor, Office of the Staff Judge Advocate, Dover AFB, DE, 1995-1998
  • Adjunct Professor, Written and Oral Advocacy, The University of Maryland Francis King Carey School of Law, 2019-2020

Recognition & Leadership

  • Team Member, a Law360 “Product Liability Practice Group of the Year,” 2021
  • Recipient, FDA Office of the Commissioner, “Outstanding Service Award,” 2019
  • Recipient, U.S. Air Force, “Meritorious Service Medal,” 2001
  • Recipient, U.S. Air Force, “Commendation Medal,” 1998, 1999
  • Member, District of Columbia Bar Association, 1998-Present
  • Member, Maryland Bar Association, 1997-Present

Credentials

Education
  • J.D., with distinction, University of Iowa College of Law
    • Associate Editor, Iowa Law Review
    • American Jurisprudence Award in Constitutional Law
  • B.A., Michigan State University
Admissions
  • District of Columbia
  • Maryland
  • U.S. District Court for the District of Columbia
  • U.S. District Court for the District of Maryland
  • U.S. Court of Appeals for the Third Circuit
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. Court of Appeals for the Sixth Circuit
  • Supreme Court of the United States