Gerald F Masoudi

Before joining Covington in 2009, Mr. Masoudi served as Chief Counsel of the Food and Drug Administration. In that capacity 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 the products regulated by FDA. Before joining the FDA, Mr. Masoudi served as Deputy Assistant Attorney General for international, policy and appellate matters in the Antitrust Division at the Department of Justice. He also served as Principal Deputy Chief Counsel for the FDA in 2004 and 2005. Before entering government service, Mr. Masoudi had a decade of experience in private practice in the areas of antitrust, telecommunications, patent law and energy. REPRESENTATIVE MATTERS Conducted internal investigations of medical products manufacturers relating to alleged misconduct in product development and manufacturing. Advised companies responding to FDA inspection reports (483s) and warning letters relating to manufacturing, labeling and promotion. Lead counsel for Genzyme corporation in negotiation of 2010 consent decree regarding Allston Landing manufacturing facility. Lead counsel for major drug manufacturer in negotiation of 2011 consent decree regarding OTC manufacturing facilities. Counsel for CEO of medical device manufacturer in negotiation of 2011 consent decree regarding device manufacturing facility. Regulatory advisor for defense of off-label/False Claims Act investigations for major pharmaceutical companies. Advised major OTC drug manufacturer on labeling and formulation requirements for wide range of OTC drugs. HONORS AND RANKINGS Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012) Best Lawyers in America (2012) LMG Life Sciences, “Life Science Star” (2012) Washingtonian Magazine, Washington's Best Lawyers (2011) The Practical Law Company (PLC) - Life Sciences, Which Lawyer? (2011-2012)