Can FDA “Do More With Less?”: McClellan
Former FDA commissioner Mark McClellan says he hopes FDA will be able to come through the current difficulties caused by a massive reorganization and use technology to “do more with less.” But, he continued, “it will be a challenge for the new team coming in to deliver on it.”
McClellan, who was FDA commissioner during the George W. Bush administration, appeared as a guest on the 4/2 CNBC “Squawk Box” show and took a measured approach to describing both the challenges and the opportunities in the staff layoffs that some have described as a bloodbath.
He noted there were some 3,500 people cut, or about 18% of the workforce. “It’s early days,” he said. “The main part of the reductions has been in support services, communications, and training. Additional people have left through early retirement.”
According to McClellan, major reductions such as the one at FDA often cause disruption initially with a loss of productivity at the beginning. “The question is how to get through something like this to something that works more efficiently at the end,” he said. “That’s a tall order for FDA right now.”
Asked to compare what is happening now with the HHS reduction when he was in government service, McClellan said the current reorganization affects significantly more people. While the earlier reorganization had some of the same goals in terms of centralizing many support functions, he said, it helped that the leadership team was in place before the reduction in force was announced.
A major challenge for HHS, McClellan said, is that each of its agencies is responsible for many different activities with little overlap. “There’s a pressure on the department to get this right,” he said, “and not create things that might be viewed as delays in access to accurate information and supporting the various agencies in their distinct activities.”
Asked if FDA had grown too much in the Obama and Biden administrations and thus needed to be cut back, McClellan said that the agency was larger before the staff cuts than it had been in 2019 and one of the goals is to get staffing levels back to where they were. But he also noted there had been bipartisan support in those administrations for many new activities and areas of focus in FDA.
Asked about concern expressed by former Administrator Scott Gottlieb over the forced departure of CBER director Peter Marks, McClellan said he agreed Marks’ departure was a concern along with other high-level departures in several areas of the agency. “We need to be watching now to see if any more senior leaders leave,” he said. “We also need to watch to see if FDA can do its usual work,” such as meeting user fee deadlines and having reviewers and other experts meet with industry in a timely way.