Howard Sklamberg, a former top U.S. Food and Drug Administration official, has joined Akin Gump Strauss Hauer & Feld in Washington, D.C., bringing him back to private practice for the first time in nearly 20 years.
Sklamberg had been the agency's deputy commissioner for global regulatory operations and policy since 2014, after serving in various roles at the FDA. He spent about a dozen years as a prosecutor at the U.S. Department of Justice before joining the agency in 2010.
In an interview with the National Law Journal, Sklamberg said it's "an interesting time" for the highly regulated industries overseen by the FDA.
As a new partner in Akin Gump's health care and life sciences regulatory practice, Sklamberg will, in part, help FDA-regulated companies develop compliance programs, including in the areas of pharmaceutical drugs, food safety and international importation matters. "The types of therapies and treatments that we're going to see over the next 10, 20 years is going to be amazing," he said, citing certain genetic-based therapies and cancer treatments. And as this science progresses, he said, "the regulatory framework and the way the FDA operates have to change with that."
Sklamberg also shared his thoughts on some of the important legal and regulatory issues that will be on the FDA's agenda in the upcoming months.
Several regulations governing the ongoing implementation of the Food Safety Modernization Act — the most sweeping overhaul of the nation's food safety system since it was enacted in 1938 — have been issued, so "the boots are hitting the ground in terms of the oversight and enforcement work that the FDA will be doing," Sklamberg said. These efforts, he added, will mean increased cooperation between the FDA and the states, as well as between the FDA and foreign regulators. In addition, advanced technology will detect the source of food-borne outbreaks a lot more quickly, placing a higher demand on the FDA's investigative functions.
In the area of pharmaceuticals, Sklamberg said to expect to see attempts at expediting the approval of generic drugs as part of the Trump administration's effort to lower drug prices. He added, however, that such action is a "multi-faceted issue" that would require the involvement of Congress and other Department of Health & Human Services agencies besides the FDA.
The FDA's increased cooperation with foreign regulatory agencies is not limited to the area of food safety, Sklamberg said, citing a mutual recognition agreement the FDA entered into with the European Union last March that allows U.S. and EU regulators to use each other's inspections of drug manufacturing facilities. He said he predicts similar initiatives in the area of medical devices.
"This is a real example of the future," Sklamberg said. "I expect to see a lot more of that increased cooperation with foreign regulators in terms of sharing information and relying on each other."