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Thomas Cosgrove

Tom Cosgrove is a partner in Covington’s Food, Drug, and Device Practice Group, where he advises global pharmaceutical and biotechnology companies on their most critical Food and Drug Administration (FDA) compliance, enforcement, and product‑quality matters. He is the only attorney ever to have served as Director of FDA’s Office of Manufacturing Quality (OMQ), giving him an unparalleled perspective on drug‑quality oversight and CGMP enforcement.

Recognized by Chambers USA (2025) for Healthcare: Pharmaceutical/Medical Products Regulatory, Tom is known for his practical judgment and his ability to translate complex regulatory requirements into clear, actionable strategies. Clients rely on his combined experience as a senior FDA official and seasoned private‑practice advisor to guide them through high‑stakes compliance challenges and evolving regulatory expectations.

Tom also brings a strong investigations and white‑collar capability that clients rely on during their most sensitive moments. He frequently leads internal reviews, counsels companies through government inquiries, and helps management teams and boards respond to potential enforcement risks. Because his investigations work is fully integrated with his FDA regulatory practice, he quickly identifies issues, assesses regulatory exposure, and delivers coordinated strategies that protect both business objectives and credibility with regulators.

His practice covers inspection readiness, Form FDA 483 responses, data‑integrity investigations, and navigating warning letters and import alerts—issues that commonly arise during global inspections and significant compliance events. He advises clients across the product lifecycle, from development and approval matters to post‑market compliance, coordinating closely with Covington’s transactional, litigation, and broader investigations teams to align regulatory strategy with broader business goals.

Before joining Covington in 2017, Tom held multiple leadership roles at the U.S. Food and Drug Administration. As Director of OMQ from 2014 to 2017, he oversaw CGMP enforcement actions including warning letters, import alerts, and civil and criminal enforcement referrals. He also served as Acting Director of CDER’s Office of Compliance, overseeing programs involving drug approval and labeling, human drug compounding, drug supply chain security and integrity, and oversight of clinical trials and bioequivalence studies. Earlier, he led the Office of Unapproved Drugs and Labeling Compliance and served as an attorney in FDA’s Office of Chief Counsel.

Widely regarded as a leading voice on drug quality and FDA regulatory strategy, Tom frequently briefs U.S. and international audiences on emerging compliance trends and the agency’s shifting expectations. Drawing on his senior FDA experience, he offers clients forward‑looking insight into how regulators assess risk and how companies can strengthen their manufacturing and quality systems to meet evolving standards.

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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

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and

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Continue Reading FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19