As the Associate Commissioner for Legislative Affairs, Kimberlee Trzeciak leads the Office of Legislation and FDA’s engagement with Congress. Ms. Trzeciak and her team advise and assist Members of Congress, congressional committees, and congressional staff on legislative matters related to FDA. She also guides Agency leadership on legislative activity.
Prior to joining FDA, Ms. Trzeciak served as senior health policy advisor on Capitol Hill for more than 15 years, most recently 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. More recently, she advised the Energy and Commerce Committee and House Democratic leadership on COVID-19 response, including the development of key policies including in Families First Coronavirus Response Act, 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, including health care coalitions, pharmaceutical manufacturers, payors, non-profit organizations, and patient groups. She also has previous experience within the corporate sector as the 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.
She began her federal government career in the office of the former Dean of the U.S. House of Representatives, John D. Dingell (D-MI), for whom she served as Legislative Director and lead health policy adviser on all matters before the Energy and Commerce Committee. She 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.