Julie Tierney is a principal based in Washington, D.C. She has over 25 years of experience in FDA law and policy. Tierney helps life sciences companies, patient organizations, and others understand and develop regulatory and engagement strategies and advance policy solutions for complex issues related to product development, review, and marketing.
Before coming to Leavitt Partners, Julie served in a number of senior roles at the U.S. Food and Drug Administration that leveraged her substantial legal, policy and operational expertise. She served as the FDA chief of staff, during which time she managed multiple public health crises and oversaw the daily management of the agency and major cross-cutting agency activities. Julie most recently served as deputy director of FDA’s Center for Biologics Evaluation and Research, where she led the center’s policy and legislative engagements related to complex biologics such as cell and gene therapies, vaccines, and blood products, cross-agency rare disease efforts, including the launch of the FDA Rare Disease Innovation Hub, and other strategic initiatives.
During her tenure at FDA, Julie helped shape solutions to some of the most challenging regulatory and legal issues, including those related to rare disease product development and FDA’s expedited programs such as accelerated approval, breakthrough designation, and regenerative medicine advanced therapy designation, as well implementation of novel programs such as qualified infectious disease product designation, the drug development tools/biomarker qualification program, and platform technology designation.
Julie served as FDA’s detailee to the U.S. Senate HELP Committee as a senior health policy advisor, where she negotiated the FDA-related provisions of 21st Century Cures Act (P.L. 114-255); upon her return to FDA, she played a key role in the implementation of this transformative legislation. Beyond her time on Capitol Hill, she remained involved in legislative and policy initiatives at FDA as a member of the negotiation team for Prescription Drug User Fee Act (PDUFA) VII and played a key role in FDA’s negotiation and implementation of major FDA-related legislation, including the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), Food and Drug Administration Reform Act of 2017 (FDARA), Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), and Food and Drug Administration Omnibus Reform Act of 2022 (FDORA). An attorney by training, Julie joined the FDA in 2008, as an associate chief counsel for drugs in FDA’s Office of Chief Counsel.
Prior to her government service, Julie practiced food and drug law at private law firms. She received her B.A. from Johns Hopkins University with a double major in Biology and History. Julie received her J.D. from Georgetown University Law Center.