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.
Back
