GERALD MASOUDI is a partner at Covington & Burling LLP. Masoudi has more than 25 years of broad experience in the life sciences industry. He served as Chief Counsel of the US Food and Drug Administration (FDA) from 2007 to 2009. Masoudi also has held positions in the Antitrust Division at the US Department of Justice; as the general counsel of two large, highly regulated companies; and as a partner in private practice. He provides strategic legal, policy, and regulatory advice to life sciences clients, with a focus on FDA enforcement of manufacturing and promotional rules. His practice will focus on guiding clients through significant corporate transactions, litigation, shifting regulatory expectations, and intensive crisis management activities. Masoudi brings a unique profile and diverse set of experiences to enforcement and compliance work on behalf of clients. These matters are often high-profile and of critical importance to our food, drug, and device clients. He guides clients through significant corporate transactions, litigation, shifting regulatory expectations, and intensive crisis management activities. Mr. Masoudi most recently served as the Chief Legal Officer, Corporate Secretary, and Counselor and Advisor to the CEO of JUUL Labs. He was responsible for the company’s global legal strategy and also was centrally involved in JUUL Labs’ crisis management efforts, including in response to congressional requests and in preparation for congressional hearings. He also supervised JUUL Labs’ strategy with respect to government investigations and civil litigation matters. From 2015 to 2018, Masoudi was the Executive Vice President, General Counsel and Corporate Secretary of Celgene Corporation, a publicly traded biopharmaceutical company now owned by Bristol-Myers Squibb Company. While at Celgene, he was involved in numerous major legal and strategic matters, including IP strategy; two multibillion-dollar corporate acquisitions; a False Claims Act settlement resulting in no Corporate Integrity Agreement; antitrust litigation; congressional and public policy strategy relating to regulatory issues; and corporate governance. Masoudi was a partner and co-chair of Covington’s Food and Drug Practice Group from 2009 to 2015. Before joining Covington in 2009, he served as Chief Counsel of FDA, where he was responsible for supervising FDA’s involvement in civil and criminal litigation and investigations; providing legal review of warning letters, guidances and regulations; and providing advice to the FDA commissioner and senior leadership on matters relating to FDA regulated products. Before joining the FDA, Masoudi served as Deputy Assistant Attorney General for international, policy, and appellate matters in the Antitrust Division at the DOJ. Prior to entering government service, Masoudi had a decade of experience in private practice in the areas of antitrust, telecommunications, patent law, and energy.
