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November 9, 2015
WASHINGTON, DC, November 9, 2015 - Denise Esposito, who served as Chief of Staff to the Commissioner of the US Food and Drug Administration and FDA’s Deputy Chief Counsel for drugs and biologics, has joined Covington as a partner and co-chair of its Food & Drug practice group.
“Denise has played a central role on issues of critical importance to our clients in the pharmaceutical and biotechnology industry, and her perspective and expertise will be highly valued by our clients,” said Tim Hester, the firm’s chair. “She presents a rare opportunity for us to add a high quality lawyer from senior positions at FDA, who also has strong in-house and private practice experience, and we expect her to play a vital role in sustaining and expanding our preeminent FDA practice for the next generation.”
Ms. Esposito held several senior executive positions at the FDA between 2010 and 2015, including Chief of Staff, Deputy Chief Counsel, and Deputy Director and Acting Director of the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research.
As Chief of Staff, Ms. Esposito provided strategic advice to the Commissioner and senior FDA officials on significant policies and initiatives and coordinated and managed the Commissioner's priority issues and agency operational issues. This role provided her exposure to issues and senior officials in all of the sectors that the FDA regulates, including drugs, biological products, medical devices, and foods.
In her role as the Deputy Chief Counsel for drugs and biological products in the FDA’s Office of the Chief Counsel, Ms. Esposito was the senior drugs and biologics regulatory lawyer at FDA. Ms. Esposito advised the agency on a wide range of important legal and policy issues relating to the regulation of drugs and biological products, including constitutional challenges to the FDA’s regulation of the pharmaceutical industry, federal preemption of state law, market exclusivity, biosimilars, drug shortages, prescription drug promotion, expedited drug approval, and drug withdrawals.
From 2010 to 2013, while at CDER, the FDA center responsible for the regulation of drugs and many biological products, she worked on a broad spectrum of legislative, regulatory, and policy matters, including implementation of major legislation enacted before and during her tenure, promulgation of FDA regulations, responding to industry Citizen Petitions, and various FDA administrative proceedings.
“I am excited to join Covington’s leading FDA practice and look forward to focusing on a range of regulatory, strategic, and policy matters for clients around the world, while also drawing on my background in litigation, corporate governance, and transactions,” said Ms. Esposito.
Prior to joining the FDA, Ms. Esposito served as the as the Senior Vice President, General Counsel, and Secretary of Emergent BioSolutions. At Emergent, she managed the company’s initial public offering; negotiated US government contracts for the development and procurement of biological products; developed and implemented compliance, governance, and risk management programs; oversaw the company’s intellectual property portfolio and acquisitions and dispositions of technology; and managed the company’s litigation. Before joining Emergent, Ms. Esposito was a partner at a major international law firm, where she represented pharmaceutical and biotechnology companies in litigation and other matters.
Ms. Esposito graduated cum laude with a BA in economics from Rutgers University and with a JD magna cum laude and Order of the Coif from the University of Michigan School of Law.