Kimberlee Trzeciak is the Deputy Commissioner for Policy, Legislation, and International Affairs. In this role, she provides strategic policy direction to advance FDA’s mission and vision of protecting and promoting public health and oversees the agency’s engagement with Congress and global partners and state, local, territorial, and tribal policymakers. Ms. Trzeciak led the Office of Legislation and FDA’s engagement with Congress, where she and her team advised and assisted Members of Congress, congressional committees, and congressional staff on legislative matters related to FDA.
Ms. Trzeciak served as a senior health policy advisor on Capitol Hill for nearly 15 years, first as Legislative Director and lead health policy advisor to the former Dean of the U.S. House of Representatives, John D. Dingell (D-MI) and later as Chief Health Policy Advisor to Chairman Frank Pallone on the House Committee on Energy and Commerce. In this role, she led the Subcommittee on Health overseeing the Committee’s public health policy work, including all policy related to FDA. During her time in the House, she led the drafting or negotiation over a wide range of FDA and public health legislation, including 21st Century Cures Act, the Food and Drug Administration Reauthorization Act, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, and key provisions in the Food and Drug Administration Safety and Innovation Act and the SUPPORT for Patients Act. She also advised the Energy and Commerce Committee and House Democratic leadership on COVID-19 response, including the development of key policies including in the CARES Act and the American Rescue Plan.
Before joining the Energy and Commerce Committee, Ms. Trzeciak served as vice president of government relations in the health practice of a leading public affairs firm where she provided strategic guidance to a wide spectrum of public health stakeholders, as well as director of federal government affairs at a global generic and specialty pharmaceutical company, where she focused on implementation of the Drug Quality and Security Act and strategic engagement with policymakers around the Generic Drug User Fee Act.
Ms. Trzeciak has a master’s degree in government from Johns Hopkins University and received a bachelor’s degree in public and corporate communication from Butler University.