Food inspections, drug reviews at risk as shutdown slows FDA
The head of the Food and Drug Administration said that a government shutdown prevents it 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.
THREAD - UPDATE ON SHUTDOWN: We’re making decisions across our portfolio to focus #FDA resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance.— Scott Gottlieb, M.D. (@SGottliebFDA) January 8, 2019
We’ll release more details on these re-allocations in coming days. We’re systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can. Our consumer protection role is our most critical mission.— Scott Gottlieb, M.D. (@SGottliebFDA) January 8, 2019
All of our work at the #FDA is critical, so nothing we stand down is unimportant. But 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 .— Scott Gottlieb, M.D. (@SGottliebFDA) January 8, 2019
In a subsequent post Wednesday, Gottlieb said 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.
THREAD: Food Safety During Shutdown: We’re taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities. 31% of our inventory of domestic inspections are considered high risk— Scott Gottlieb, M.D. (@SGottliebFDA) January 9, 2019
Note: We’re still doing ALL of our regular foreign food inspections. But, on the domestic side, in rough numbers we’d typically do about 160 domestic food inspections each week, and about 1/3 of those would be considered high risk.— Scott Gottlieb, M.D. (@SGottliebFDA) January 9, 2019
We assess risk based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include: the type of food, the manufacturing process, and the compliance history of the facility.— Scott Gottlieb, M.D. (@SGottliebFDA) January 9, 2019
Commodities deemed high risk include, but aren’t limited to: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products....— Scott Gottlieb, M.D. (@SGottliebFDA) January 9, 2019
.... (continued) unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods.— Scott Gottlieb, M.D. (@SGottliebFDA) January 9, 2019
Unlike the US 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 are not 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.
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 e-mail.
‘‘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 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.