William M. Zoffer

Independent Consultant

William M. Zoffer

Education

J.D. (cum laude), Harvard Law School

Summary of Experience

Mr. Zoffer is an expert in pharmaceutical regulatory law, risk management, and compliance. His Food and Drug Administration (FDA) experience spans nearly three decades in industry and government, including roles at GlaxoSmithKline (GSK) and the US Department of Justice (DOJ). Mr. Zoffer’s expertise as a legal practitioner, including his time at DOJ, has focused on dispute resolution, advocacy, and advice on regulatory issues within the FDA’s jurisdiction, including brand and generic drug approval standards; questions at the interface of patent and regulatory law, including those arising from the Hatch-Waxman Amendments and related litigation matters; promotional practices; safety and product risk management; and good laboratory, clinical, and manufacturing practices (GxP). At GSK, Mr. Zoffer helped health care enterprise leaders manage challenges and opportunities arising at the intersection of business, medicine, science, policy, regulation, and law. In his last decade at GSK, he reported to the global general counsel and led divisions of the legal department dedicated to supporting global drug discovery and development, as well as US and worldwide prescription drug and vaccine commercialization. Before joining GSK, Mr. Zoffer worked at the DOJ as a trial attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), where he litigated and investigated civil and criminal matters related to the FDA. Mr. Zoffer teaches FDA law at the Wake Forest University School of Law, and has taught at Duke University School of Law.

AG Contacts

Pierre Y. Cremieux