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Dr. Hamburg announced the appointment of Howard Sklamberg as Deputy Commissioner for Global Regulatory Operations and Policy, effective January 13, 2014.
January 13, 2014
Over recent years, globalization, scientific innovation, the increasing breadth and complexity of the products that we regulate, and groundbreaking legislation have created great challenges and opportunities for us. We are rising to these challenges in many ways, including making our decisions more risk based, increasing specialization and the vertical integration of our programs, deepening our collaboration with our global and state regulatory partners, and implementing our new authorities. The Office of Global Regulatory Operations and Policy, which consists of the Office of Regulatory Affairs and the Office of International Programs, will be vital to implementing these changes. I am confident that Howard will provide the strong leadership needed for the Office of Global Regulatory Operations and Policy to seize these opportunities and advance our mission to promote and protect the public health.
Howard’s experience is well suited to this position. For the last year, Howard has served as Director of CDER’s Office of Compliance, where he has played a key leadership role in implementing parts of the generic drug user fee program, the development of new drug quality compliance policy, oversight of pharmacy compounding, defending against threats to the drug supply chain, expanding cooperation with international regulatory partners, and implementing provisions of the Food and Drug Administration Safety and Innovation Act and the recently enacted Drug Quality and Security Act.
Prior to joining CDER, Howard served in the Office of Regulatory Affairs, first as Director of its Office of Enforcement and then as the Deputy Associate Commissioner for Regulatory Affairs. Howard’s efforts within ORA contributed to improvements in federal-state relationships for the Foods program, streamlining of the Agency’s approval process for seizures and injunctions, and development and use of the Food Safety Modernization Act’s new enforcement tools. He also enhanced coordination between criminal and regulatory enforcement and oversaw ORA’s work with CDRH on the Case for Quality Initiative to foster medical device quality.
Howard has a B.A. from Yale University, a J.D. from Harvard Law School, and an M.A. from the Fletcher School of Law and Diplomacy. Before coming to FDA, he was a federal prosecutor, serving as an Assistant U.S. Attorney for the District of Columbia and as a Trial Attorney in the Justice Department’s Public Integrity Section. He also served as Deputy Chief of the Fraud and Public Corruption Section of the U.S. Attorney’s Office. Since 1999, Howard has been an adjunct professor at American University’s Washington College of Law, where he teaches courses on Congressional investigations and white collar crime.