Covington & Burling LLP operates as a limited liability partnership worldwide, with the practice in England and Wales conducted by an affiliated
limited liability multinational partnership, Covington & Burling LLP, which is formed under the laws of the State of Delaware in the United States
and authorized and regulated by the Solicitors Regulation Authority with registration number 77071..
Denise Esposito co-chairs Covington & Burling’s global Food, Drug, and Device Practice Group. Denise has more than 30 years of experience in the life sciences industry, including in senior leadership roles within the U.S. Food and Drug Administration (FDA), as the General Counsel of a publicly traded biopharmaceutical company, and as a Partner in private practice. She provides strategic, policy, and regulatory advice to biopharmaceutical, medical device, and other FDA-regulated clients, with a focus on matters that involve navigation of FDA and the complex political and policy challenges faced by regulated industry. Denise’s practice includes advising clients on product development, marketing authorization strategies, incentive programs, expedited approval programs, life cycle management, and the advertising and promotion of medical products. She works with clients on FDA engagement strategies, formal and informal FDA dispute resolution, FDA administrative hearings and public meetings, and crisis management around FDA actions.
Denise’s work runs the gamut of therapeutic areas and product types, including infectious disease, oncology, regenerative medicine, combination products, diagnostics, and digital health. She also has specialized expertise in the development and approval of medical countermeasures (MCMs) against pathogens that can cause global pandemics or be used in acts of bioterrorism or bio-warfare and was part of the FDA's Medical Countermeasures Initiative MCMi team while at the Agency. She has worked with FDA, the Biomedical Advanced Research and Development Authority (BARDA), and other agencies involved in the U.S. government's response to national public health emergencies and was heavily involved in the industry’s response to the COVID-19 pandemic.
Denise joined Covington in 2015 from FDA, where she served most recently as Chief of Staff to the Commissioner. In that role, Denise provided strategic advice to the Commissioner and other senior FDA officials on significant FDA policies and initiatives, and coordinated and managed the Commissioner's priority issues and agency operational issues. Prior to becoming Chief of Staff, Denise served as the Deputy Chief Counsel for Drugs and Biological Products in FDA’s 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).
Denise is Chambers-ranked in the U.S. and globally for Life Sciences Regulatory and Compliance and has been named a Life Sciences “Power Player” by Insider.
Chambers USA, Life Sciences: Regulatory/Compliance (2017-2024)
Chambers Global, Life Sciences: Regulatory/Compliance (2020-2024)
Legal 500 US, Healthcare - Life Sciences (2017)
Previous Experience
U.S. Food and Drug Administration, Chief of Staff to the Commissioner; Deputy Chief Counsel, Drugs and Biological Products, Office of Chief Counsel; Deputy Director for Policy, Center for Drug Evaluation and Research (CDER)
Emergent BioSolutions Inc., Senior Vice President and General Counsel
Partner in Life Sciences and Litigation Practices at Major International Law Firm
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