Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, which provides direction to FDA’s domestic and international product quality and safety efforts and oversees the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP). ORA is responsible for conducting inspections, recalls, import operations, criminal enforcement, regulatory science, and working with FDA’s product centers to develop and execute compliance policy. ORA has authority over drugs, medical devices, biologics, food, animal feed, cosmetics, and tobacco, a budget of over $900 million, and a staff of 4,400 employees in 13 laboratories and over 200 offices across the country. OIP coordinates FDA’s international efforts, including multilateral and bilateral relationships, international agreements, and increasing cooperation and data sharing with foreign regulatory partners. OIP collaborates with ORA to perform foreign inspections and has eight overseas offices.
Prior to being named Deputy Commissioner in January 2014, Mr. Sklamberg served for one year as Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research. He led the Office in its efforts to protect the American public from unsafe and ineffective drug products. Mr. Sklamberg played key leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners.
Mr. Sklamberg also served as Deputy Associate Commissioner for Regulatory Affairs in ORA from July 2011 until he joined CDER in January 2013. Prior to that, he was Director of ORA's Office of Enforcement.
Before coming to FDA, Mr. Sklamberg was a federal prosecutor serving as Deputy Chief of the Fraud and Public Corruption Section in the United States Attorney’s Office for the District of Columbia, as an Assistant U.S. Attorney in that office, and as a Trial Attorney in the Justice Department's Public Integrity Section. He specialized in the prosecution of white-collar crime.
Mr. Sklamberg graduated from Harvard Law School, received a bachelor’s degree in economics and political science from Yale University, and earned a master’s degree from the Fletcher School of Law and Diplomacy. He also served as a law clerk to Chief Judge Richard S. Arnold of the US Court of Appeals for the Eighth Circuit and as Minority Counsel for the US Senate Committee on Governmental Affairs.