Ex-FDA Official Leaves Akin Gump for Arnold & Porter as Regulatory Questions Swirl
Howard Sklamberg joined Arnold & Porter on Monday and was immediately placed on his new firm's COVID-19 task force.
March 23, 2020 at 04:27 PM
3 minute read
Arnold & Porter Kaye Scholer has added Akin Gump Strauss Hauer & Feld partner and former Food and Drug Administration deputy commissioner Howard Sklamberg as a partner in Washington, D.C.
Sklamberg, whose first day at Arnold & Porter was Monday, will be part of the firm's life sciences and health care regulatory practices. He was immediately placed on his new firm's COVID-19 task force.
Sklamberg's arrival comes as questions about the nation's medical regulatory regime have gained special urgency, with the United States and other countries scrambling to respond to the coronavirus pandemic. Many are pushing to streamline approvals from the FDA and other agencies to expedite effective treatments, for example.
While Sklamberg said his decision to change firms predated the COVID-19 outbreak, given the nature of his practice, the move makes even more sense now.
"My decision to move was based on Arnold & Porter's strong FDA platform, specifically in medical products and food," Sklamberg said in an interview. "Obviously when I was in the process we were not in the COVID-19 pandemic, but it makes the move even more of a strong decision as there are a lot of FDA regulated clients that will have questions now and for years to come."
In late February, the agency lifted restrictions on state and local testing labs, allowing them to conduct COVID-19 tests without waiting for FDA clearance. Sklamberg said that while the FDA is reallocating resources from other areas to combat COVID-19, he sees the agency doing it in a measured way.
"The FDA is not doing routine inspections now, for example," he said. "You can think of it as delaying your annual physical. It is a small increase in risk and manageable, but that doesn't mean you should put it off forever."
Sklamberg spent the last two-plus years as a partner at Akin Gump, but before that spent seven years at the FDA in various roles, culminating in his work as deputy commissioner for global regulatory operations and policy from 2014 through 2017.
During his tenure there, Sklamberg oversaw the FDA's inspectorate, criminal enforcement, recall and regulatory enforcement functions, according to Arnold & Porter.
While at Akin Gump, Sklamberg advised clients on FDA compliance matters, including investigations, recalls and inspection preparation, according to his firm bio. Sklamberg also advised pharmaceutical companies on submission of drug applications, including regulatory, congressional and pricing issues.
"His experience as a senior official at the FDA, where he played a central role in coordinating global agency operations, will greatly benefit our clients," Dan Kracov, co-chairman of Arnold & Porter's life sciences and health care regulatory practice, said in a statement.
Before joining the FDA in 2010, Sklamberg was a federal prosecutor for eight years, serving as an assistant U.S. attorney in D.C. and as deputy chief in the DOJ Criminal Division's Fraud and Public Corruption Section.
Akin Gump said in a statement that the firm wishes Sklamberg well.
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