FDA restarts some food, drug inspections halted by shutdown

Hundreds of Food and Drug Administration inspectors and other staff will resume work beginning Tuesday, focusing on facilities that produce higher-risk foods, drugs and devices, according to the agency’s commissioner.

Those workers, who had been furloughed because of the government’s partial shutdown, will be unpaid, said FDA Commissioner Scott Gottlieb, who discussed the move in tweets and and a subsequent interview.

About 150 of the returning workers are in the food area. Most are inspectors but some work in laboratories and other jobs, Gottlieb said. As many as 250 more employees will be resuming work in the drug and device inspection area.

The FDA commissioner praised the workforce, saying in the interview that he got an “overwhelmingly positive” response when he raised the prospect of inspectors returning to work without pay.

The FDA, which oversees about 80 percent of the food supply, had suspended routine inspections of domestic food-processing facilities because of the government shutdown.

Routine inspections occur at both “low-risk” and “high-risk” facilities. The latter group includes plants that produce foods such as seafood, baby formula and soft cheese, and drugs and devices that must be kept sterile, or have a history of safety problems. Sampling of imported, high-risk food products at ports of entry also have restarted, Gottlieb said.

The agency typically conducts about 160 routine food inspections a week, with one-third targeting facilities considered high risk. The low-risk inspections will not resume because of the shutdown.

Bringing the inspectors back to work was a “major functional accomplishment” for the agency, Gottlieb said, adding that he got the final go-ahead on Friday from the Office of Management and Budget, and the Department of Health and Human Services.

Sandra Eskin, director of the Safe Food Project at The Pew Charitable Trusts, praised Gottlieb “for doing everything he can to ensure that the risk to consumers is minimized.” However, she added, the situation “underscores the vital rule that government plays in consumer health and safety and why it’s so important to get the government back up and running.”

Some other high-priority inspections — including those involving foodborne disease outbreaks and product recalls — have been conducted throughout the shutdown by unpaid staff. Food inspections involving meat and poultry are conducted by the Agriculture Department; those inspections have continued throughout the shutdown with unpaid inspectors.

About 60 percent of the FDA’s work — including drug and device product reviews — are covered by user fees paid by industry. Those activities are continuing, but Gottlieb said that the agency could begin running out of the fees used for drug reviews in five weeks.

Most routine drug and device inspections, as well as most food-related work, are not paid for by user fees. Those tasks are covered by congressional appropriations, which have not been approved.

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