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FDA head: Baby formula factory could reopen by next week

WASHINGTON (AP) – The head of the Food and Drug Administration told lawmakers on Thursday a formula factory for babies with rollers could be put into operation next week, although he bypassed questions about whether his company should have intervened earlier to deal with factory problems the national shortage.

The FDA Commissioner, Dr. Robert Calif, faced bipartisan criticism from Parliament lawmakers over the issue of infant formula outraged American parents and take political responsibility for President Joe Biden.

The problems are largely due to the Abbott Nutrition formula factory in Michigan, the largest in the US, which has closed since February due to infection problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending upgrades and safety certifications.

“We had to fight Abbott,” Khalif told members of a House subcommittee. “I think we are well on our way to opening it within the next week to two weeks.”

After the resumption of production, Abbott said, it may take about two months for the new formula to arrive in stores. Califf said it would be “a few weeks” before supplies returned to normal, especially in rural areas.

When lawmakers asked why it took the FDA months to investigate an informant alleging security breaches at Abbott’s plant, Califf said he could not share details due to the agency’s ongoing investigation. Several lawmakers rejected this answer.

“It’s unacceptable to say that you just can not comment,” said Mark Pocan, a spokesman for D-Wisconsin. “This is a problem I have seen over and over with the FDA: you are not good at communicating.”

Caliph is the first government official to testify before Congress about the shortage, which has left some parents chasing the formula and has become a political point of contention for Republicans. Biden announced sweeping new steps to improve U.S. supplies Wednesday night, including invoking the Law of Defense Production and fly in imported formula from abroad.

Rosa DeLauro spokeswoman D-Conn. Repeatedly asked Califf to explain what the FDA had done after receiving an informant complaint in October alleging that there were several security breaches at the Abbott plant, including workers who falsified files and did not the formula before publishing them. The former Abbott employee was not interviewed by the FDA until the end of December and the plant closed by mid-February, he noted.

“Everything begs the question, why did the FDA not take action?” Delauro asked. “Who in the leadership had access to this report – who did not have access to the report – and why was there no reaction?”

Califf said he had considered the complaint, but did not specify when or what immediate action was taken.

“I promise to contact you for details on what happened, I just am not prepared for today,” Khalif said.

One point that lawmakers and Califf have agreed on is that the centralized nature of the US formula market makes it extremely vulnerable to unrest. Only four companies produce about 90% of the US formula, including Abbott, Gerber, Perrigo and Reckitt. These companies also dominate federal contracts that provide about half of all U.S. drugs through a program called WIC, for low-income mothers, children, and babies.

Abbott closed its plant in Michigan in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The first of these cases was reported to the FDA in September, but service staff did not begin inspecting the facility until the end of January.

Califf said earlier this week the agency’s investigation is ongoing and has not yet concluded whether bacteria from the plant caused the infants’ infections. Abbott said there was no direct evidence linking her products to the disease.

The lack of milk for babies is the first big crisis for Califf since then returning to the FDA in February. He briefly headed the service under President Barack Obama and was re-elected to his position based on his previous experience as head of the extensive body that regulates food, medicine, medical technology and tobacco.

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

“I knew very well when I came in that we needed to make significant improvements to the FDA’s food side – not because people are bad – but there is a need for consistent leadership and the right resources,” Califf told lawmakers.

The funding request comes amid long-standing concerns that the FDA’s food program – which oversees most U.S. foods other than meat, poultry and eggs – has been underfunded and underfunded compared to its medical departments.

On Wednesday afternoon, House Democrats voted a $ 28 million spending account which would enhance FDA funding for the inspection of domestic and international formula manufacturers. His fate in the Senate is uncertain.

Leading Republican subcommittee Andy Harris, a Republican from Maryland, said many of the FDA’s problems could be “solved with strong leadership, not money.”

While supporting the increase in funding, DeLauro also said that the problems in the organization’s food center are deeper.

“You have serious structural, leadership issues,” he told Calif. “Someone at this agency must have serious, relevant food credentials. “Otherwise, the food will be a second-class citizen in the FDA.”

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Follow Matthew Perrone on Twitter: @AP_FDAwriter.

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

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FDA head: Baby formula factory could reopen by next week Source link FDA head: Baby formula factory could reopen by next week

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