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Denise Esposito

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.

On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products. 

Key Provisions of the EO

In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):

  1. “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
  2. “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA. 
  3. “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.

Continue Reading Executive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders