Kimberlee Trzeciak

Kimberlee (Kim) Trzeciak is Vice President of U.S. Government and Regulatory Affairs at the U.S. Pharmacopeia (USP), where she leads engagement with FDA, Congress, and federal policymakers to advance policy solutions that strengthen patient access to safe, quality medical products. She brings nearly 20 years of experience in FDA regulatory policy, legislation, and stakeholder engagement across FDA, Capitol Hill, industry, and the healthcare sector. Kim has helped shape, negotiate, reauthorize, and implement FDA user fee programs from multiple vantage points, giving her a practical understanding of how regulatory policy is developed, funded, and translated into agency action. On Capitol Hill, she helped negotiate landmark FDA legislation, including laws that created and renewed the generic drug and biosimilar user fee programs and supported FDA oversight of over-the-counter medicines. At FDA, she served as Associate Commissioner for Legislative Affairs, helping lead the agency’s user fee strategy and congressional engagement, and later as Deputy Commissioner for Policy, Legislation, and International Affairs, FDA’s top policy role. In these roles, she advanced policy initiatives related to medical product oversight, patient access, product quality, innovation, and supply chain resilience. Kim also has advised healthcare and life sciences organizations on FDA regulatory strategy and worked in government affairs for a global generic and specialty pharmaceutical company. With experience on the Hill, inside FDA, in industry, and now at USP, Kim brings a practical, forward-looking perspective on how policy decisions in Washington can translate into stronger regulatory systems, more resilient supply chains, and better access to safe, quality medical and consumer health products. Kim holds a Master of Arts in Government from Johns Hopkins University and a Bachelor of Arts from Butler University.