Denise Esposito’s practice focuses on a broad range of regulatory, strategic, and policy matters affecting pharmaceutical, medical device, and food and beverage companies. She has deep experience on issues of critical importance to the life sciences industry, including the Biologics Price Competition and Innovation Act (BPCIA) and regulation of innovator biological products and biosimilars, exclusivity determinations for drugs and biological products, and the regulation and enforcement of drug promotion.
Ms. Esposito joined Covington from the U.S. Food and Drug Administration (FDA), where she served as Chief of Staff to the Commissioner. In this role, Ms. Esposito provided strategic advice to the Commissioner and senior FDA officials on significant FDA policies and initiatives, and coordinated and managed the Commissioner's priority issues and agency operational issues. She also previously served as Deputy Chief Counsel for Drugs and Biological Products in the FDA Office of the Chief Counsel, and as Deputy Director and Acting Director of the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER).
Ms. Esposito has been representing pharmaceutical and biotechnology clients for more than twenty years. Her experience encompasses a wide range of important legal and policy issues relating to the regulation of drugs and biological products, including constitutional challenges to FDA’s regulation of the pharmaceutical industry, federal preemption of state law, market exclusivity, biosimilars, drug shortages, prescription drug promotion, expedited drug approval, and product withdrawals. Ms. Esposito also has substantial expertise in the regulation and procurement of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases.