FDA Head: Baby formula factory may open next week

WASHINGTON (AP) – The head of the Food and Drug Administration told lawmakers on Thursday that the infant formula plant could start as early as next week, although he sidestepped whether his agency should have intervened earlier to address the plant’s problems. which caused a 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. Caliph said it would take “several weeks” before supplies returned to normal, especially in rural areas.

When lawmakers were asked why it took the FDA several months to investigate an informant’s complaint about security breaches at the Abbott plant, Caliph said he could not share details about the agency’s ongoing investigation. 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 a political topic of conversation 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.

A spokeswoman for Rosa DeLavra, D-Conn., Has repeatedly asked Caliph to explain what the FDA did after receiving a complaint from an informant in October about numerous security breaches at the Abbott plant, including staff who falsified records and failed to properly verify the formula before release her. The former Abbott employee was not interviewed by the FDA until the end of December, and the plant was not closed until mid-February, she noted.

“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.

“I’m ready to tell you the details of what happened, I’m just not ready for today,” said Caliph.

One point that lawmakers and Caliph agreed on is that the concentrated nature of the formula market in the U.S. makes it very vulnerable to violations. Only four companies produce about 90% of the American formula, including Abbott, Gerber, Perrigo and Reckitt. These companies also dominate federal contracts, providing about half of all formulas in the U.S. through the WIC program for low-income mothers, children, and infants.

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, but 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 understood very well that we needed to make major improvements in the FDA’s food sector – not because people are bad – but we need 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 – is underfunded and underdeveloped compared to medical units.

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. Her fate in the Senate is uncertain.

While DeLavra supports this increase in funding, she said the agency’s food center problems are deeper.

“You have serious structural problems, problems with leadership,” she told Calif. “Someone in this agency needs to have serious relevant food certificates. Otherwise, the food will be a second-class citizen at the FDA. ”