Akin Gump today announced that Howard R. Sklamberg, former Deputy Commissioner for Global Regulatory Operations and Policy at the Food and Drug Administration (FDA), has joined the firm as a partner in its health care and life sciences regulatory practice in Washington, D.C. Mr. Sklamberg comes to Akin Gump after a distinguished tenure at the FDA, where he held a series of influential positions.
Mr. Sklamberg most recently directed the FDA’s domestic and international quality and safety efforts and oversaw both its Office of Regulatory Affairs (ORA) and Office of International Programs (OIP). This included coordination of standards and agreements with foreign countries, implementation of new food safety and medical product programs and alignment of agencywide enforcement strategies. Mr. Sklamberg oversaw an office with authority over food, drugs, medical devices, biologics, cosmetics and tobacco; a budget of more than $1 billion; and a staff of 5000 employees in more than 200 offices, laboratories and import facilities across the United States and overseas. Mr. Sklamberg also interacted with, and testified before, Congress on behalf of the agency.
Earlier at the FDA, Mr. Sklamberg served as Director of the Office of Compliance, Center for Drug Evaluation and Research . In that role, he led the office that oversees risk-based compliance strategies for drugs, including manufacturing and quality standards, compounding, imports and exports, counterfeit drugs, supply chain issues, recalls and outbreaks, labeling requirements, over-the-counter drugs and clinical trials.
“Howard represents a terrific addition to our health practice and broader regulatory team,” said Akin Gump chairperson Kim Koopersmith. “Our clients will benefit substantially from his valuable background and experience while at the FDA, which included making many important enforcement and policy decisions concerning major FDA-regulated companies, particularly those in the pharmaceutical and food sectors. I am delighted to welcome him to Akin Gump.”
Mr. Sklamberg strengthens a health practice that includes former FDA lawyer and Senate Health, Education, Labor and Pensions Committee advisor Nathan Brown, who joined Akin Gump in 2014. Mr. Brown advises health industry participants on regulatory, compliance and policy issues pertaining to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the FDA.
“Howard will enhance our practice in two very important ways—through his strong enforcement and compliance work as well as through his knowledge of the pharmaceutical and food sectors,” said John R. Jacob, head of Akin Gump’s health care and life sciences practice. “Additionally, he brings significant international experience, having overseen FDA’s negotiations on a variety of international trade agreements affecting FDA-regulated entities. I am thrilled that Howard is joining our team and know that our clients will benefit greatly from the rich mix of skills, industry knowledge and global experience that he possesses.”
Added Mr. Sklamberg, “Akin Gump’s health practice is a recognized leader in its field, and this is an incredible opportunity to join a firm with such enormous talent. The chance to work again with Nate Brown, who played a leading role in many high-priority FDA matters during my tenure at the agency, was also very appealing. I am excited to work with my many new colleagues in expanding the services we offer to life sciences and food companies as they navigate the shifting FDA landscape.”
About Howard R. Sklamberg
During his years at the FDA, Mr. Sklamberg also served as Deputy Associate Commissioner for Regulatory Affairs, supervising agency activities relating to enforcement, product recall decisions, implementation of new food safety enforcement authorities and import procedures. Prior to that, he was Director of ORA’s Office of Enforcement, managing many of FDA’s product recalls and civil enforcement matters and reforming the agency’s compliance practices.
Mr. Sklamberg previously spent about a dozen years working 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.
Mr. Sklamberg received his J.D., magna cum laude, from Harvard University, an M.A.L.D. from the Fletcher School of Law and Diplomacy at Tufts University and a B.A., summa cum laude, from Yale University.
Source: www.akingump.com
