Abbott, the largest US supplier of powdered infant formula, including Similac, on Monday agreed with the FDA on the steps needed to resume production at the plant.
“I’m happy to say today that we’ve already made significant progress and I think we’re on track to open it in the next week or two, most likely the outer two weeks.” Califf told a US House of Representatives panel.
The company recalled infant formula products and closed the factory in February after reports of serious bacterial infections in four infants, exacerbating a shortage at several manufacturers that began with supply chain problems in case of pandemic.
The FDA investigated Abbott after reports that four babies who had been fed formula made at that plant fell ill with Cronobacter sakazakii infections.
The agency cannot conclude whether the cases of sick babies are directly linked to the Abbott plant until its investigation is complete, Califf said.
The FDA works closely with Abbott and he personally receives two daily reports on the plant’s remediation efforts, he told lawmakers.
“It looks like things are going well, that Abbott has remedied a number of issues, and we’re going to make sure that gets done as quickly as possible.”
The FDA is confident that more products “can quickly hit US stores,” he said, but it will still be weeks before formula stocks return to normal. People are buying more formula now than before the recall, which makes distribution more difficult, he added.
The national shortage has left parents scrambling to feed their babies and the US government looking for short-term solutions while scrambling to find longer-term ones.
President Joe Biden invoked the Defense Production Act on Wednesday to help manufacturers obtain ingredients to boost supply.
The House of Representatives on Wednesday passed two bills, including one providing $28 million in emergency funding for the FDA, backed by 219 Democrats and 12 Republicans. She was opposed by 192 Republicans.
A second measure, passed 414-9, would ensure low-income families would continue to use their allowances to purchase formula under a federal program for women, infants and children known as WIC.
Both bills must also be passed by the Senate, which is very divided.
DERELICTION OF DUTY
House Appropriations Committee Chair Rosa DeLauro questioned Mr. Califf, who appeared before an Appropriations subcommittee to discuss the FDA’s budget request for fiscal year 2023, on its response to the shortage.
The FDA said Monday it would allow imports of infant formula from foreign manufacturers that don’t typically sell their products in the United States to help ease the shortage.
“I remain concerned about the safety of the formulas that end up on our shelves,” Ms. DeLauro said, adding that she was concerned that “the guidelines recently issued by the FDA do not go far enough to ensure the safety of the formulas.”
She also criticized the FDA for moving too slowly after receiving a whistleblower report in October. DeLauro cited the report last month when she called for a government investigation.
“Anyone who reviewed this report felt that there was no need to react at all from October to February until there was a recall. It’s a dereliction of duty, in my opinion,” it said. she said, referring to then-Acting Commissioner Janet Woodcock.
As part of his response, Mr. Califf has given Ms. Woodcock a greater leadership role on food issues.
“Now it looks like this person is going to oversee this effort. He’s the fox in the coop,” DeLauro said.