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. Howard is also a litigator and represents FDA-regulated companies and individuals in criminal and civil investigations, discovery, and trial.
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.
Experience
- Pharmaceutical company in conducting an investigation of data integrity issues and in advising on potential compliance actions by FDA and other agencies.
- 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 company in discovery and civil trial regarding a dispute over the provisions of a merger agreement related to the development of a drug and FDA compliance issues.
- 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 negotiating with the Justice Department and FDA regarding a possible consent decree related to FDA manufacturing compliance issues.
- 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.
- Medical device company in Justice Department investigation of potential off-label promotion.
- 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.
Perspectives
Recognition
Healthcare: Life Sciences (2021)
Credentials
Education
- J.D., Harvard Law School, magna cum laude
- M.A.L.D., Fletcher School of Law and Diplomacy
- B.A., Yale University, summa cum laude
Admissions
- District of Columbia
- New York
Government & Military Service
- Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration
- Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Deputy Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration
- Director, Office of Enforcement, U.S. Food and Drug Administration
- Deputy Chief, Fraud & Public Corruption Section, U.S. Attorney's Office for the District of Columbia
- Assistant U.S. Attorney, U.S. Attorney's Office for the District of Columbia
- Trial Attorney, Public Integrity Section, Criminal Division, U.S. Department of Justice
- Minority Counsel, Special Investigation of the 1996 Election Campaign, Committee on Governmental Affairs, U.S. Senate
Clerkships
- U.S. Court of Appeals for the Eighth Circuit, The Honorable Richard S. Arnold
Activities
- Barrister, Edward Bennett Williams Inns of Court