FDA Commissioner Scott Gottlieb testified before the House Committee on Appropriations Wednesday on the current state of agency activities. Gottlieb expressed confidence that the agency is “back on track,” despite the 35-day lapse in FDA appropriations during the longest partial government shutdown in US history.
Members of the subcommittee on agriculture, rural development, FDA and related agencies questioned Gottlieb on the status of the agency’s operations, particularly regarding efforts to mitigate the impact of the government shutdown. They pointed to FDA’s inspectional work of medical product manufacturing facilities and reserve of industry user fees as areas of concern.
Gottlieb affirmed there were some FDA programs, including certain policy work, that were more impacted by the shutdown than others. “Inspectional work will be diminished over the course of the year probably by about 10% from where we would have been,” Gottlieb added. He described steps the agency initiated to help FDA investigators continue to conduct site inspections when it became clear the shutdown was going to last longer than originally anticipated, despite the investigators having to work without pay.
In his written testimony, Gottlieb attributed the need for reduced goals around inspections, imports and field sampling to a shift in the focus of inspectional work due to the shutdown. “This is because we focused on the highest risk establishments during the lapse, and many other types of inspections didn’t take place,” he wrote. “The effected [sic] programs include human and animal food, biologics, and devices.”
The agency believes its original goals for pharmaceutical and compounding inspections will not be impacted.
On user fee timelines, Gottlieb also informed subcommittee members the agency intends to meet review goals for drug and medical device applications despite the lapse in appropriations. He also indicated in his written testimony that FDA will work to mitigate impacts on these goals over course of the year.
Credit: Getty Images.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.
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