Association for Accessible Medicines
601 New Jersey Ave NW, Suite 850
Washington, DC 20001
E: [email protected]
Howard Sklamberg counsels clients on a wide range of compliance and enforcement issues related to U.S. Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug, and medical devices law and policy, and is able to guide domestic and international clients through the regulatory challenges they face. Areas of focus include inspections and warning letters, investigations, civil and criminal enforcement and litigation, medical product applications and clinical research, food and hemp regulation, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies.
Prior to entering private practice, Howard held a variety of roles at FDA from 2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories, and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Howard was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls, and import operations programs.
Howard also led FDA’s international program, including its agreements and cooperation with foreign regulators, harmonization initiatives, and oversight over the global supply chain. He also interacted with and testified before Congress on behalf of the agency, co-led FDA’s implementation of the FDA Food Safety Modernization Act, and was the lead official at FDA on a variety of issues, including cannabis and hemp, counterfeit drugs, and FDA’s Mutual Recognition Agreement with the European Union.
Earlier in his career, Howard served as a prosecutor in the U.S. Attorney’s Office in Washington, D.C., and in the Public Integrity Section of the Criminal Division at the Department of Justice. As a prosecutor, Howard was the sole or lead prosecutor in over 40 criminal trials.