Howard Sklamberg counsels clients on a wide range of compliance and enforcement issues related to US Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of US 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 expertise include inspections and warning letters, investigations, civil and criminal enforcement, 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, Mr. Sklamberg held a variety of roles at the 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, Mr. Sklamberg was FDA's top enforcement official. He oversaw the agency's inspections, enforcement, recalls, and import operations programs.
Mr. Sklamberg 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, Mr. Sklamberg served as a prosecutor in the US Attorney's Office in Washington, DC, and in the Public Integrity Section of the Criminal Division at the Department of Justice.
- Major pharmaceutical and medical device companies in preparing for and responding to FDA inspections, including FDA 483s.
- Major pharmaceutical and medical device companies in recalls and FDA compliance actions, including warning letters, civil money penalty proceedings, and import actions.
- Major pharmaceutical and medical device companies in seeking FDA approvals and clearances, including approval strategy, clinical trial compliance issues, and communications with Institutional Review Boards.
- Pharmaceutical company in an extensive internal investigation regarding safety data in an FDA submission.
- Pharmaceutical company in dispute with contract manufacturer regarding cGMP deficiencies.
- Pharmaceutical companies in improving global manufacturing compliance systems and compliance with Drug Supply Chain Security Act.
- Pharmaceutical companies in resolving issues related to potential contaminants in products.
- Major trade associations in the development of FDA compliance and inspection policy.
- Pharmaceutical companies in the development of HHS and FDA policy regarding onshoring and supply chain oversight.
- Retailer in internal investigation of compliance with FDA Food Safety Modernization Act.
- Hemp manufacturer in the development of FDA policy regarding cannabidiol.
- Dietary supplement manufacturer in the submission of a New Dietary Ingredient Notification.
- Food and medical product company in FDA and Justice Department investigation of FDA current good manufacturing practice compliance.
- Private equity firms in acquisitions of medical product and food companies.
Healthcare: Life Sciences (2021)
- JD, Harvard Law School, magna cum laude
- MALD, Fletcher School of Law and Diplomacy
- BA, Yale University, summa cum laude
- District of Columbia
- New York
- Deputy Commissioner for Global Regulatory Operations and Policy, US Food and Drug Administration
- Director, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration
- Deputy Associate Commissioner for Regulatory Affairs, US Food and Drug Administration
- Director, Office of Enforcement, US Food and Drug Administration
- Deputy Chief, Fraud & Public Corruption Section, US Attorney's Office for the District of Columbia
- Assistant US Attorney, US Attorney's Office for the District of Columbia
- Trial Attorney, Public Integrity Section, Criminal Division, US Department of Justice
- Minority Counsel, Special Investigation of the 1996 Election Campaign, Committee on Governmental Affairs, US Senate
- United States Court of Appeals, Eighth Circuit, The Honorable Richard S. Arnold
- Barrister, Edward Bennett Williams Inns of Court