Baby formula factory could reopen next week

WASHINGTON (AP) — The head of the Food and Drug Administration told lawmakers Thursday that a shuttered baby formula factory could be up and running as soon as next week, though he sidestepped questions about whether his agency should

have intervened earlier to address problems at the plant that triggered the national shortage.

FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden.

The problems are largely tied to Abbott Nutrition's Michigan formula plant, the largest in the U.S., which has been closed

since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications.

"We had to wrestle this to ground with Abbott," Califf told members of a House subcommittee "I think we are on track to get it open within the next week to two weeks."

After production resumes, Abbott has said, it could take

about two months before new formula begins arriving in

stores. Califf said it will be "a few weeks" before supplies returns to normal levels, especially in rural areas.

When lawmakers asked why it took the FDA months to investigate a whistleblower

complaint about safety violations at Abbott's plant, Califf

said he couldn't share details due to the agency's ongoing investigation. Several lawmakers rejected that response.

"It's not acceptable to say you just can't comment on it," said Rep. Mark Pocan, D-wisconsin. "This is a problem I've seen over and over with the FDA: You guys aren't good at communicating."

Califf is the first administration official to testify before Congress on the shortage, which has left some parents

hunting for formula and become a political talking point for Republicans. On Wednesday evening Biden announced

sweeping new steps to improve U.S. supplies, including

invoking the Defense Production Act and flying in imported formula from overseas.

Rep. Rosa Delauro, D-conn., repeatedly asked Califf to explain what the FDA did after receiving a whistleblower complaint in October alleging

numerous safety violations at Abbott's plant, including employees falsifying records and failing to properly test formula before releasing it. The former Abbott employee wasn't interviewed by the FDA until late December and the plant wasn't closed until mid-february, she noted.

"It all begs the question, why did the FDA not spring into action?" Delauro asked. "Who

in the leadership had access to that report — who didn't have

access to the report — and why was there no reaction?"

Califf said he had reviewed the complaint but didn't specify when or what immediate

steps were taken.

"I am committed to getting back to you on specifics of what happened, I'm just not prepared to today," Califf said.

One point on which lawmakers and Califf agreed is that concentrated nature of the U.S. formula market

makes it highly vulnerable to disruption. Just four companies produce an estimated 90% of U.S. formula, including Abbott, Gerber, Perrigo and Reckitt. Those companies also

dominate federal contracts that provide about half of all U.S. formula through a program called WIC, for low-income mothers, children and babies.

Abbott shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The first of those cases was reported to the FDA in September, but agency staff didn't begin inspecting the facility until late January.

Califf said earlier this week the agency's investigation is

ongoing and it hasn't yet reached a conclusion on whether bacteria from the

plant caused the infant infections. Abbott has said there is

no direct evidence linking its products to the illnesses.

The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. He briefly led the agency under President

Barack Obama and was tapped for the job again based

on his past experience leading the sprawling agency, which regulates food, drugs, medical technology and tobacco.