White House says deal near to reopen formula plant

WASHINGTON (AP) — Under fire from parents and politicians, President Joe Biden's administration on Monday is expected to announce an agreement to reopen the largest domestic manufacturing plant of infant formula and to ease import rules to allow supplies in from overseas, amid a nationwide shortage.

A consent decree between the producer, Abbott, and the Food and Drug Administration that would pave the way for reopening the plant is “forthcoming,” said Brian Deese, the director of the White House’s National Economic Council. He added the agency would also take steps Monday to allow more foreign imports into the U.S. to address the urgent supply constraints.

The White House said it is working with all major formula producers to boost production, including reaching out to their suppliers to encourage them to prioritize production and delivery of formula ingredients. It comes as the Biden administration has come under intense pressure over the last week to do more to ease the shortage of formula that has forced parents of infants to go to significant lengths to feed their children.

The shortage stems from a February recall by Abbott, the nation’s largest formula maker, that shuttered the company’s Michigan plant and exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country. The shortage has led retailers like CVS and Target to limit how many containers customers can purchase per visit and forced some parents to swap and sell formula online.

On Monday, FDA Commissioner Robert Califf told ABC News’ “Good Morning America” that the federal agency is “working really closely with Abbott” to reopen the closed Michigan factory and he expects that “in a very short period of time we’re going to have an announcement about the path forward.”

Califf said an announcement is forthcoming about importing baby formula from abroad, noting that the key is making sure the instructions for the formula are in languages that mothers and caregivers can understand.

The FDA warned families against making their own baby formula because it has 30 distinct constituents that have to be in the right amount, otherwise the formula can possibly be dangerous to consume.

Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from the Michigan plant. All four infants were hospitalized with a rare type of bacterial infection and two died.

After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.

But Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from the babies by federal investigators. The company has repeatedly stated it is ready to resume manufacturing, pending an FDA decision.

Former FDA officials say fixing the type of problems uncovered at Abbott’s plant takes time, and infant formula facilities receive more scrutiny than other food facilities. Companies will need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.

Even if the facility reopens soon, the FDA will still face scrutiny for its handling of the issues at the plant.

FDA inspectors visited the factory in September for a routine inspection, around the time that the first bacterial infection was reported in an infant. Although inspectors uncovered several violations— including standing water and unsanitary conditions— the FDA did not shut down the plant or issue any formal warning.

Only after several more illnesses were reported did the FDA return to the plant in January, this time finding a history of bacterial contamination in several parts of the plant. Abbott then shut down the facility and recalled several powdered formulas in mid-February.

Congresswoman Rosa DeLauro reported last month that a whistleblower had contacted the FDA in September about unsafe conditions and practices at the plant, including falsifying plant records and failing to properly test formula for contamination.

She and other lawmakers are set to question FDA Commissioner Califf about that issue and others at a hearing scheduled for Thursday.