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FDA head: Baby formula factory could reopen by next week – Atlanta, Georgia

Atlanta, Georgia 2022-05-19 13:33:23 –

Washington (AP) — The Director of the Food and Drug Administration told legislators Thursday: Milk powder factory with shutters He avoided asking if his agency should intervene in the central factory sooner, but could be up and running soon next week. Country shortage..

FDA Commissioner Dr. Robert Caliph faced a bipartisan grill from Congressmen over the issue of infant formula. Furious American parents It will be the political responsibility of President Joe Biden.

The problem is primarily related to the Michigan Formula Plant, the largest Abbott Nutrition in the United States. Closed from February due to pollution problems.. The FDA announced a preliminary agreement with Abbott earlier this week and resumed production awaiting safety upgrades and certification.

“We had to fight this against Abbott,” Caliph told members of the House Subcommittee.

According to Abbott, it could take about two months for the new formula to arrive in stores after production resumes.

When lawmakers asked why the FDA took months to investigate warnings about safety breaches at the factory, Caliph said he couldn’t say much because of the ongoing investigation of the problem. Some lawmakers declined the response.

“It’s unacceptable to say you can’t comment,” said Mark Pokan, a member of D-Wisconsin. “This is a problem I’ve seen many times at the FDA. You’re not good at communicating.”

The caliph was the first executive to testify before parliament about the shortage, which caused some parents to seek a formula and become a Republican issue. On Wednesday night, Biden announced a radical new step to improving supply in the United States. Invoking the Defense Production Act I am flying with a formula imported from overseas.

Members of the House Expenditure Committee held a hearing on Thursday asking Caliph why the FDA did not intervene last fall when it was warned of a problem at its Sturgis, Michigan plant.

D-Conn. Rosa DeLauro pointed out a recently announced whistleblower complaint. This includes a number of safety breaches at Abbott’s factory, including employee tampering with records and improper testing before announcing the official. She said a former Abbott employee warned the FDA of the situation in October, but was not interviewed by government staff until late December.

“It all raises questions, why didn’t the FDA take action?” De Lauro asked. “Who in the leadership could access the report, who couldn’t access it, and why didn’t it respond?”

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

“The most worrying responsibility is the loss of organizational integrity,” Caliph said. “If that integrity is compromised, the question is how to trust the installed system.”

D-Georgia’s Sanford Bishop Subcommittee Chairman described the FDA’s delay in action as “not conscientious.”

“Americans rely on the FDA to protect their baby’s health by ensuring that safe powdered milk is available,” Bishop said.

Abbott closed its Michigan plant in February after FDA inspectors began investigating four bacterial infectious diseases in infants who consumed prescriptions from the plant. These first cases were reported to the FDA in September, but government officials did not begin inspecting the facility until late January. Caliph said earlier this week authorities were investigating and had not yet reached a conclusion as to whether bacteria from plants caused the baby’s infection.

Abbott states that there is no direct evidence linking its products to illness.

Insufficient milk powder is the first major crisis for caliphs. Return to FDA in February.. He temporarily led an agency under President Barack Obama and re-employed based on his past experience of leading a vast agency that regulates food, medicine, medical technology and tobacco. ..

The hearing on Thursday will consider the FDA’s budget requirements for next year, and Caliph has asked lawmakers for $ 76 million in new funding for food safety and nutrition.

“I was well aware that the FDA needs to make significant food improvements, not because they are bad, but it requires consistent leadership and appropriate resources,” Caliph told Congressman. ..

The funding request came amid long-standing concerns that the FDA’s food program, which oversees most US foods except meat, chicken and eggs, is underfunded compared to the FDA’s pharmaceutical and medical sector. It is done.

House Democrats passed on Wednesday night $ 28 million bill It will boost the FDA’s funding to inspect national and international formula producers. The fate of the Senate is uncertain.

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