House lawmakers hammered at Dr. Robert Califf, the head of the Food and Drug Administration, during a budget hearing Thursday on how the agency is dealing with the infant formula shortage that is making families across the country worse.
His appearance before a House subcommittee came just a day after President Biden invoked the Defense Production Act and authorized the use of airplanes to transport baby food from abroad to increase supply. The agency and the White House have raced in recent days to respond to public outcry over bare supermarket shelves and worries that desperate parents are rationing their supplies or resorting to potentially risky DIY mixtures to feed their babies. .
The latest shortfall stems from the February shutdown of Abbott Laboratories’ plant in Sturgis, Michigan, where the FDA had found evidence of a potentially deadly bacterium called cronobacter sakazakii. The company launched a major recall that has led to gaping holes in its supply chain. Federal agencies investigated several infant illnesses last fall, including two deaths, although no definitive link to formula has been established.
dr. Califf acknowledged to lawmakers that the agency was conducting an internal review to see if mistakes had been made. Pressured by lawmakers for a timetable to help families, Dr. Califf listed efforts underway — including relaxed import guidelines and ramping up domestic production — and said increased supply to stores would be noticeable within days. He reiterated that the Abbott factory should reopen in two weeks, but said store shelves would not return to normal in the coming weeks.
Representative Rosa DeLauro, a Connecticut Democrat and chair of the House Committee on Appropriations, was one of the panelists Dr. Califf compelled to account for what they characterized as the agency’s slow response to obvious issues and an alarming whistleblower report. She outlined the events leading up to the recall, including a September inspection that revealed evidence of the bacteria in the finished formula and a whistleblower’s report that raised a range of concerns.
Read more about the shortage of baby food
“It all begs the question of why the FDA didn’t act?” asked Ms. DeLauro. “Why did it take four months to get this formula off the shelf? How many more illnesses and deaths were caused by the slow response of the FDA?”
Aside from the president’s actions, Dr. Califf insisted that the Justice Department had reached a settlement with Abbott that required tighter security measures and an independent supervisor at the plant.
“With these three recent promotions, we expect additional products to be able to hit US stores soon,” said Dr. Califf. But he warned that distribution would still be a concern for certain areas, particularly rural communities.
The baby food shortage started during the pandemic and worsened after the recall at the Abbott plant, which makes up an estimated 25 percent of U.S. supply. As baby food stocks began to decline in recent months, sales began to surge, most likely as a result of a wave of panic buying.
Mrs. DeLauro asked Dr. Califf also said whether the FDA’s plan to lower barriers to importing foreign formulas would allow unsafe products into the country, given voluntary safety guidelines that allow for “third-party” certification of standards.
dr. Califf said the agency was at liberty to reject any applicant. “We don’t allow infant formulas in the US that are not safe,” he said.
He was also questioned about findings from the Centers for Disease Control and Prevention and the agency, based on samples of the cronobacter bacteria associated with two out of four infants who became sick in recent months. Those were compared with five strains of bacteria found at the Sturgis plant, said Dr. Califf. The agencies and Abbott have said there was no match between them.
dr. Califf said the FDA investigation would continue.
“We can’t say that the cases came directly from that factory until the investigation is fully completed,” he said.
Navigating the US Baby Food Shortage
A growing problem. A nationwide baby food shortage – caused in part by supply chain problems and exacerbated by a recall from baby food manufacturer Abbott Nutrition – has left parents confused and concerned. Here are some ways to deal with this uncertainty:
Representative Lauren Underwood, an Illinois Democrat, also addressed delays at the Abbott plant, asking why the agency hadn’t considered an on-site inspection as critical even though domestic on-site assessments had been suspended because of the Omicron wave. dr. Califf acknowledged that failure to prioritize the baby food inspection could be a mistake, the agency notes in its assessment.
Several proposals are under consideration in the House of Representatives and the Senate that require greater food safety supervision and improve the formula supply chain.
On Wednesday, the House approved a $28 million emergency infusion for the FDA and a bill to relax the limits on the types of formulas that can be purchased with benefits from the special supplemental nutrition program for women, infants and children known as WIC. About half of the formula sold in the United States is sourced with WIC benefits. The Senate is expected to approve changes to the federal food aid program.
dr. Califf asked lawmakers to approve an $8.4 billion budget, which would be $2.1 billion above last year’s levels. That includes a $76 million increase in food safety funding, which would go toward improving technology to quickly trace foodborne illnesses to their source and other efforts to reduce toxins in food.
But additional funding to the FDA was expected to meet stiff resistance from Senate Republicans. In a message sent to regular lawmakers, Republican leaders criticized Democrats for abandoning the two-pronged efforts and instead offering legislation “with no plan to actually fix the problem, while not holding the FDA accountable.”
The House Energy and Commerce Committee has booked top executives from the FDA and formula companies for a hearing next Wednesday on formula safety and delivery.
Senator Ron Wyden, an Oregon Democrat, also announced a Senate Finance Committee investigation into Abbott’s investments in security improvements amid record revenues.