Elaine Lippmann, J.D., is a Principal at Leavitt Partners based in Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy. Elaine is a strategic thinker whose deep understanding of FDA processes, drug law, and health policy helps clients across the life sciences sector navigate uncertainty and complex challenges.
Elaine most recently served as leadership in the Office of Regulatory Policy within the Center for Drug Evaluation and Research (CDER). In this role, she advised agency senior leadership on drug policy development, implementation, and strategy and led a multidisciplinary team in advancing major regulatory and legal initiatives. She helped shape regulations, policies, and procedures on a wide range of issues central to the pharmaceutical industry, including approval pathways, competition, product quality and compliance, artificial intelligence, and advanced manufacturing.
From her tenure with the FDA, Elaine is widely recognized as one of the foremost legal authorities on postmarket safety, including Risk Evaluation and Mitigation Strategies (REMS), safety labeling, and postmarket requirements. She has worked closely with industry, clinicians, and patient groups to resolve complex regulatory challenges and shape national policy.
Before her federal service, Elaine practiced at a Washington, D.C. law firm, representing government and public agency clients in regulatory, transactional, and administrative litigation matters.
Elaine earned her Juris Doctorate from Northeastern University School of Law and her bachelor’s degree from Oberlin College.