Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Jill P. Furman, JD
Director
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Jill Furman, J.D., serves as the Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER). The Office of Compliance is charged with protecting the public from poor quality, unsafe, and ineffective drug products through proactive compliance strategies and risk-based enforcement actions.
Ms. Furman joined FDA in 2020 as the Office of Compliance Deputy Director after more than 22 years with the U.S. Department of Justice’s (DOJ) Consumer Protection Branch, where she handled a wide range of consumer protection matters, including civil and criminal litigation under the Food, Drug, and Cosmetic Act. In her last eight years at DOJ, Ms. Furman served as the Deputy Director of that office, supervising litigation, and providing leadership and direction to attorneys and staff.
Before joining DOJ, Ms. Furman served as an Assistant District Attorney with the Suffolk County District Attorney’s Office in Boston, Massachusetts, where she prosecuted criminal cases in state appellate and trial courts.
Ms. Furman earned her law degree from Boston University School of Law and her bachelor’s degree from the University of Pennsylvania.
Abstract
Jill P. Furman presents an overview of the CDER Office of Compliance responsibilities and the various tools used to ensure drug safety and effectiveness. The office holds a broad mandate, overseeing the entire drug lifecycle from manufacturing to post-market requirements, including imports, compounding, online pharmacies, and unapproved drugs. Compliance strategies are grounded in science and law, employing tools like stakeholder engagement, issuing warning letters, placing firms on import alert, recommending recalls, and utilizing remote regulatory assessments. The office prioritizes actions based on highest risks, such as products linked to injuries, quality issues, or those intended for vulnerable populations. Recent efforts have addressed critical issues like DEG/EG contamination, non-compliant ophthalmic products, unapproved drugs, and risks associated with online marketplaces. The presentation highlights publicly available resources like the Pharmaceutical Inspections and Compliance webpage and the FDA Data Dashboard for accessing compliance data. It also discusses a proposed unified compliance program within CDER aimed at streamlining operations and maximizing public health impact. The office remains vigilant and adaptable to address both long-standing and emerging threats.