WASHINGTON – The head of the Food and Drug Administration told lawmakers on Thursday that the factory of baby formulas with shutters could start working next week, although he avoided whether his agency should have intervened earlier at the plant in the center of the national deficit.

FDA Commissioner Dr. Robert Calif has faced bipartisan House of Representatives lawmakers over the issue of the child mix that has angered American parents and become a political responsibility for President Joe Biden.

The problems are largely related to Abbott Nutrition’s Michigan formula plant, the largest in the U.S., which has been closed since February due to pollution problems. Earlier this week, the FDA announced a preliminary agreement with Abbott to resume production pending security and certification updates.


“We had to deal with this with Abbot,” Caliph told members of the House subcommittee. “I think we’re on track to open it in the next week or two.”

After the resumption of production, Abbott said, it could be about two months before the new formula begins to arrive in stores.

When lawmakers were asked why it took the FDA months to investigate warnings about safety breaches at the plant, Caliph said he could not say much because of the investigation into these issues. Several lawmakers rejected this answer.

“It’s unacceptable to say you just can’t comment on that,” said spokesman Mark Pocan of Wisconsin. “It’s a problem I’ve seen at the FDA over and over again: you guys don’t know how to communicate.”

Caliph is the first administration official to testify before Congress about the deficit, which forced some parents to look for a formula and became the subject of talk for Republicans. On Wednesday night, Biden announced broad steps to improve U.S. supplies, including the use of the Defense Manufacturing Act and flights of imported formula from abroad.


Members of the House Appropriations subcommittee opened the hearing Thursday, asking Caliph why the FDA did not intervene last fall when there were warnings about problems at a factory in Sturgis, Michigan.

A spokeswoman for Rosa DeLavra, D-Conn., Pointed to a recently published complaint by an informant alleging that there were numerous security breaches at the Abbott plant, including staff falsifying records and not checking the formula properly before releasing it. She said the former Abbott employee alerted the FDA about the situation in October, but was not interviewed by agency staff until late December.

“All of this raises the question of why the FDA didn’t take action?” DeLavra asked. “Who in management had access to this report – who did not have access to the report – and why was there no reaction?”

Caliph said he had considered the complaint but did not specify when or what immediate action was taken. He said the allegations raised serious concerns about Abbott’s operations.


“The most worrying accusation is that the integrity of the organization has been violated,” Caliph said. “Once that integrity is broken, the question is how one can trust any of the existing systems.”

The chairman of the subcommittee, a representative of Sanford Bishop, Georgia, called the backlog in FDA action “unscrupulous.”

“American people are counting on the FDA to protect the health of babies by ensuring they have access to a safe mixture,” Bishop said.

Abbott closed its plant in Michigan in February after FDA inspectors began investigating four bacterial infections in infants who used mixtures from the plant. The first of these cases was reported to the FDA in September, although agency officials did not begin inspecting the facility until late January. Caliph said earlier this week that the agency’s investigation was ongoing and it had not yet concluded whether the bacteria from the plant had caused childhood infections.

Abbott said there is no direct evidence linking his products to the disease.


The shortage of infant formula is the first serious crisis for Caliph since returning to the FDA in February. He briefly ran the agency under President Barack Obama, and was re-invited to the post based on his past experience as head of a broad agency that regulates food, medicine, medical technology and tobacco.

A hearing on Thursday was scheduled to consider the FDA’s budget request for next year, and Caliph asked lawmakers for $ 76 million in new funding for food and nutrition safety.

“I was well aware that we needed to make major improvements in the FDA’s food sector – not because people are bad – but there is a need for consistent leadership and the right resources,” Caliph told lawmakers.

The request for funding comes amid long-standing fears that the FDA’s food program – which controls most U.S. food except meat, poultry and eggs – has been underfunded compared to the agency’s drug and medical agency.


On Wednesday night, members of the House of Representatives passed a $ 28 million bill that would increase FDA funding to test domestic and international formula manufacturers. His fate in the Senate is uncertain.


Follow Matthew Perrone on Twitter: @AP_FDAwriter.


The Associated Press Department of Health and Science receives support from the Department of Science Education of the Howard Hughes Medical Institute. AP is fully responsible for all content.


This story has been corrected to show that MP Mark Pocan is a Democrat, not a Republican.

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