JEFF SENGER handles the most significant and complex issues for pharmaceutical and medtech companies worldwide, informed by his experience as the former Acting Chief Counsel of the Food and Drug Administration and a leading litigator at the U.S. Justice Department. Prior to joining the firm, he led the FDA’s legal office and its 100 lawyers. He is an honors graduate of Harvard College and Harvard Law School. He wrote an award-winning book about resolving conflicts with the government titled Federal Dispute Resolution, and he serves as an expert witness, arbitrator, and mediator.
Jeff has represented such companies as Abbott, Amazon.com, Apple, Bayer, Cardinal Health, Celgene, Colgate, Garmin, Intel, Microsoft, and Pfizer in a wide range of regulatory or enforcement matters. Jeff’s recent experience includes:
- Advising global and U.S. companies on a broad range of FDA regulatory and enforcement issues, arbitration, and litigation;
- Dispute resolution, appeals, and related interactions with FDA officials and divisions;
- Digital health issues including innovative technology and general wellness products;
- Counseling on advertising, promotion, and First Amendment matters;
- Responses to Warning Letters, 483s, import detentions, FDA civil and criminal enforcement actions, and consent decrees;
- Drug approval strategies involving new drug applications, 505(b)(2) applications, abbreviated new drug applications (ANDAs), and product life cycle management;
- Crisis management on product recalls, inspections, adverse events, and related issues;
- Department of Justice investigations alleging False Claims Act issues, off-label promotion, and other FDA violations;
- Compliance issues involving current Good Manufacturing Practice (GMP), Quality Systems Regulation (QSR), adverse event reports, Risk Evaluation and Mitigation Strategies (REMS), and the Drug Supply Chain Security Act; and
- Service as expert witness, mediator, and arbitrator.
Jeff is consistently ranked among the country’s top FDA lawyers by leading national publications. Chambers USA noted in 2021, “He is very thorough and prepared. He's a deep analytical thinker, but with practical and user-friendly advice on how to best position our issue with the FDA and internal audiences” and “I'm impressed with his oral advocacy skills.” Who’s Who Legal wrote, “Jeffrey Senger has ‘enviable experience’ in FDA processes and related litigation having previously served as acting chief counsel and deputy chief counsel of the Food and Drug Administration” and “there are few who can match his knowledge and experience of FDA regulations and enforcement.” Legal 500 stated that Jeff has experience “that is broad and deep.” LMG Life Sciences ranked him as a “Star” and “industry leader” for both pharmaceuticals and medical devices, adding, “he deserves to be recognized for his work in the field” and “Jeffrey Senger is someone with general counsel experience at the FDA.” They also named him “FDA Medical Devices Attorney of the Year.”
Jeff previously served for 17 years as a litigator at the United States Department of Justice. As Senior Counsel in the Office of the Associate Attorney General, he provided advice on the strategic oversight of the civil components of the Department, with more than 6,500 employees and collective budgets over US$3 billion, including particular responsibility for the office that provides counsel and legal representation to the FDA. As Senior Trial Attorney and Special Assistant United States Attorney, he served as lead counsel in many civil and criminal trials before juries and judges in federal and state courts, and he argued cases in the United States Circuit Courts of Appeals. He directed civil and appellate training at the Justice Department’s National Advocacy Center. He began his career as a law clerk for a United States District Court judge.
He has been recognized as a Fellow with the Chartered Institute of Arbitrators, a Distinguished Neutral arbitration and mediation panelist with the CPR International Institute for Dispute Resolution, a panelist with the American Arbitration Association and District of Columbia Bar Association, and a mediator for the District of Columbia Superior Court and United States District Court.
Jeff has taught trial advocacy, mediation and negotiation at Harvard Law School, and he is an elected member of the American Law Institute. He is a member of the D.C. Circuit Judicial Conference, has testified as an expert witness before the United States Congress, served as chair of the editorial board for the Food and Drug Law Journal, and spoken on behalf of the United States government on five continents.