WASHINGTON ( Associated Press) — U.S. regulators have historically inspected baby formula plants at least once a year, but they have banned any of the three largest manufacturers in 2020, according to federal records reviewed by the Associated Press. not inspected.
When they arrived inside the Abbott Nutrition Formulas plant in Michigan after a two-year hiatus, they found standing water and loose sanitation procedures. But inspectors only made voluntary suggestions to fix the problems, and issued no formal warnings.
The inspectors would return five months later, when four infants who consumed powdered formula from the plant contracted a bacterial infection. They found bacterial contamination inside the factory, which led to a four-month shutdown and turned a supply shortage into an absolute crisis, which left parents scrambling to find the formula and the U.S. to airlift products from overseas. forced to
The gap in baby formula plant oversight, brought on by the COVID-19 pandemic, is drawing new scrutiny from Congress and government watchdogs probing the series of missteps leading to the crisis. A recent bill would require the Food and Drug Administration to inspect infant formula facilities every six months. And the government’s inspector general for health has launched an investigation into the FDA’s handling of Abbott’s facility, the largest facility in the US.
Abbott resumed production at the plant earlier this month under a legally binding agreement with the FDA, but the shutdown and nationwide shortages highlighted how concentrated the industry has become in the U.S., with a handful of companies in the market. of about 90%.
As COVID-19 spread across the US in early 2020, the FDA pulled most of its safety inspectors from the field, skipping thousands of routine plant inspections.
The agency said in a statement that the FDA conducted more than 800 “mission critical” inspections during the first year of the pandemic. Regulators select facilities for inspection based on whether they pose a specific safety risk or are required to produce a significant medical therapy.
Of the 23 facilities in the country that make, package or distribute formula, only three made the cut. The FDA resumed routine inspections in July 2021.
Inspection records reviewed by the Associated Press show a gap of 2 1/2 years between the FDA’s 2019 inspections and when regulators returned to plants owned by the three major formula makers: Abbott, Reckitt and Gerber.
In fact, according to agency records, the FDA has yet to return to a major Reckitt-owned plant and two plants owned by Gerber. All those facilities are working round the clock to fuel US Formula production.
“The FDA would have been more likely to catch these issues if they had been inspecting during the pandemic,” said Sarah Sorscher, a food safety specialist with the Center for Science in the Public Interest. He acknowledged that the FDA faced difficult trade-offs in reducing exposure to COVID-19 to its inspectors. “There was definitely a price to pay for the safety of our employees during that time.”
Baby formula manufacturers were “consistently identified as a high priority during the pandemic,” and there is currently no backlog of oversight, the agency told the Associated Press in response to inquiries about gaps. The agency said it skipped about 15,000 US inspections because of COVID, but it has already made about 5,000 of them, exceeding its targets.
Under current law, the FDA is only required to inspect formula facilities every three to five years, but the agency has consistently inspected the facilities every year — until the pandemic.
“Our top priority now is addressing the urgent need for infant formula in the US market, and our team is working day and night,” the FDA said.
But outside experts say the gap in oversight speaks of a blind spot in the government’s response efforts, which have been successful in preventing shortages of medicines and other medical supplies.
FDA commissioner Robert Calif says regulators knew the closure of Abbott’s plant would cause supply problems, but in February when inspectors closed the plant and more recently to allow more imports from abroad There was little evidence of urgency among the emergency measures.
Longtime food safety experts see a deeper problem at the highest levels of the FDA, where for decades physicians and medical scientists have prioritized monitoring of drugs and medical products over food.
“It is very challenging for them to be involved in this field at all because they don’t have the background, knowledge and experience,” said Steven Mandernach, executive director of the Association of Food and Drug Officials. Level Inspector.
The FDA shares oversight of food production and safety with the US Department of Agriculture. FDA oversight of food facilities peaked in 2011 and has declined for most of the years, despite increases in funding and powers by Congress. The FDA said that while US inspections have declined, foreign facility inspections have increased.
There is no certainty that additional inspections during COVID-19 would have prevented contamination problems at the Sturgis, Michigan, plant, which was closed. And Abbott says its products have not been directly linked to infections, two of which were fatal.
But the plant has had prior problems, including a 2010 formula recall due to possible contamination with insect parts.
“I think that facilities that were aware of the problems that pose a food safety risk should have been part of the FDA’s mission critical work,” Mandernach said. “And this feature would have been among them.”
Not having regular inspections — or even their threat — can lead to culture changes in plants like abbots, Mandernach said.
“If you’re driving on the highway and you know state troopers have been fired, could you go a little faster than if you knew there was a soldier on duty?” Mandarnach asked.
Follow Matthew Perron on Twitter: @AP_FDA Writers.
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