Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), right, is sworn in before a House Oversight and Investigations Subcommittee hearing in Washington, D.C., U.S. (Photographer: Toya Sarno Jordan/Bloomberg)  

Shutdown Puts FDA Food Inspections and Drug Reviews at Risk

(Bloomberg) -- The head of the U.S. Food and Drug Administration said that a government shutdown would prevent the agency from doing some routine food-safety inspections, and that the agency is weeks away from running out of funds it uses to review new drugs and medical products.

“The functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” FDA Commissioner Scott Gottlieb said in a tweet Tuesday.

In a subsequent post Wednesday, Gottlieb said the agency is working to continue high-risk food inspections.

“There’s discussion today that we’ve ‘stopped’ high risk food surveillance inspections,” he tweeted. “Fact: We’re working to continue those inspections.”

He also said in an earlier tweet Wednesday the agency’s limited food safety inspections would be focused on products like seafood, soft cheeses and unpasteurized juice that are more susceptible to food safety risks, compared to more routine inspections.

Unlike the U.S. Department of Agriculture’s slaughterhouse inspectors, who are still on the job unpaid, the FDA performs spot checks in domestic processing facilities, focusing on those with higher risks; they aren’t keeping watch around-the-clock.

“FDA doesn’t tend to do inspections of those unless there’s been a problem,” Sarah Taber, a food-safety consultant, told Bloomberg. For some foods, most major grocers and distributors require third party, non-government audits.

Shutdown Puts FDA Food Inspections and Drug Reviews at Risk

In a possible sign of the slowed pace of inspections, the FDA hasn’t posted any new warning letters since the beginning of the shutdown, the Center for Science in the Public Interest said in an email.

“That raises concerns that enforcement activities may have effectively stopped,” the center said.

Its regulation of new medical products could be affected as well. While the FDA’s drug and medical device approval processes are partly funded with fees from companies, that money will run out since the agency can’t collect new fees during the shutdown.

Gottlieb said on Jan. 5 that the agency has enough left over funds to keep reviewing drugs and other medical products for about a month. After that, new drugs won’t get assessed by the agency unless the government reopens.

The agency pays for many medical manufacturing and food-safety inspections out of its own budget. According to a shutdown contingency plan published by the Department of Health and Human Services, the FDA “would be unable to support many routine regulatory and compliance activities,” including medical product, animal drug, and food inspections. It would also halt some research projects, according to the plan.

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