As the partial government shutdown stretches into its fourth week, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, said yesterday that inspections involving high-risk foods, such as cheese, dairy products, and some fresh produce, will restart as early as today.
On Twitter yesterday, he said sampling of high-risk imported produce is already under way in the Northeast. "We'll expand our footprint as the week progresses. Our teams are working," he said, adding that the FDA will also conduct drug compounding inspections this week.
Gottlieb said the work is being inspectors that are largely unpaid. "These men and women are the tip of the spear in our consumer protection mission," he said. "The entire nation owes them gratitude. I'm inspired by their dedication."
About 400 return from furlough
In an update today, Gottlieb said about 400 staffers have returned to their posts from furlough to conduct or support high-risk surveillance inspections of food and medical products.
About 150 are involved in food inspections, and the others are working on other aspects of the FDA's mission, he said. The number includes about 100 involved in inspecting high risk medical device makers, 70 at high-risk drug producers, and 90 at high-risk biological manufacturing facilities.
Regarding the shutdown's impact on the drug approval process, Gottlieb said the agency is stretching carryover drug user fees, which should be enough to support the activities for about another 5 weeks.
"We're shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions," he said, noting that so far, the agency hasn't scaled back work on existing applications and other review functions.
The agency isn't conducting routine reviews on blood and allergenic products, though, because the programs aren't covered by user fees. The FDA is, however, monitoring for adverse events and taking actions, if needed, to protect patients.
At the US Department of Agriculture, food inspectors have continued their work, but without pay, because of federal law that require the department's inspections to continue.
See also:
Jan 14 Gottlieb Twitter thread on food inspections
Jan 15 Gottlieb Twitter thread on number of workers
