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Prominent Life Sciences Lawyer and Former FDA Deputy Commissioner Howard Sklamberg Joins Arnold & Porter

March 23, 2020

WASHINGTON, DC, March 23, 2020Howard Sklamberg — Arnold & Porter announced today that Howard Sklamberg has joined the firm's Life Sciences and Healthcare Regulatory practice as a partner, resident in the firm's Washington, DC office. Mr. Sklamberg advises clients on US Food and Drug Administration (FDA) regulation and policy, and he has assisted a wide array of FDA-regulated companies in critical FDA matters.

"Howard's arrival will further strengthen the firm's renowned global Life Sciences and Healthcare Regulatory practice, particularly with respect to FDA-regulated product manufacturing, supply chain, compliance, and enforcement issues—all areas of growing importance. His experience as a senior official at FDA, where he played a central role in coordinating global agency operations, will greatly benefit our clients," said Dan Kracov, co-chair of Arnold & Porter's Life Sciences and Healthcare Regulatory practice.

During Mr. Sklamberg's career at FDA from 2010 to 2017, he served as the 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. As Deputy Commissioner, 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 FDA's lead enforcement official, Mr. Sklamberg oversaw FDA's inspectorate, recall, criminal enforcement, and much of its regulatory enforcement functions. 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. Most recently, he joins Arnold & Porter from private practice.

Mr. Sklamberg said: "I am thrilled to be joining Arnold & Porter's premier Life Sciences and Healthcare Regulatory practice. I look forward to working with the firm's roster of talented and experienced lawyers to provide comprehensive counseling and advocacy for clients on FDA regulation and policy."

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. He had previously clerked for Chief Judge Richard Arnold for the US Court of Appeals for the Eighth Circuit.

Mr. Sklamberg earned his JD, magna cum laude, from Harvard University, and an MALD from the Fletcher School of Law and Diplomacy at Tufts University. He received his BA, summa cum laude, from Yale University.

About Arnold & Porter's Life Sciences and Healthcare Regulatory Practice

Arnold & Porter's global Life Sciences and Healthcare Regulatory practice is unique—unlike other firms, which typically scatter these capabilities across various siloed practices, we maintain a fully integrated team focused on providing comprehensive support for our clients in all areas of life sciences and healthcare regulation. Our top-tier practice has been widely recognized for its work on the most critical matters, receiving rankings from Chambers Global, Chambers USA, Chambers Europe, Chambers UK, The Legal 500 US, The Legal 500 UK, and was named Law360's 2016 Healthcare Practice of the Year. The team is comprised of experienced lawyers and other professionals, many with senior government and corporate professional experience. A number of our team's attorneys also hold advanced degrees in various scientific and medical fields, including neurobiology, endocrinology, nursing, bioethics, biophysics, biochemistry, and biotechnology.

About Arnold & Porter

With nearly 1,000 lawyers practicing in 14 offices around the globe, Arnold & Porter serves clients across 40 distinct practice areas.  The firm offers 100 years of renowned regulatory expertise, sophisticated litigation and transactional practices, and leading multidisciplinary offerings in the life sciences and financial services industries.