An FDA spokesperson declined to comment specifically on the reopening, but said the decision to publicly announce any information about plant operations would rest with Abbott.
It’s unclear why the company hasn’t yet announced that the factory is back online, but manufacturing plants are slow to ramp up, and it’s likely Abbott wanted to make sure the processes were running smoothly after previous disruptions before announcing anything publicly, one industry said. The source.
Abbott originally closed the plant in mid-February after an FDA inspection found five strains of a rare bacteria that can be deadly to infants. The plant’s closure, along with the recall of many types of formula made there, has sparked widespread infant formula shortages across the country, forcing desperate parents to rush for supplies. The plant briefly reopened on June 4, according to a schedule publicly announced by Abbott, only to close again in mid-June after the company said severe storms caused flooding in parts of the facility.
Abbott’s representative on Thursday’s FDA call said he expected a public announcement about the reopening of the Sturgis plant “soon,” according to two people on the call. Abbott’s official said he had no update on when the facility might start producing other formulas again – including some specialty formulas that are essential to the survival of some children and adults. suffering from metabolic and other disorders, and are only available in pharmacies or medical centers. supply stores. After the plant closed for the second time in June, Abbott said when production resumes it will restart production of EleCare, followed by specialty and metabolic formulas.
Beyond the federal government, other formula companies are also aware that Abbott’s plant in Sturgis is back online, according to two industry sources.
After a slow initial response, the Biden administration has worked hard over the past two months to help increase the supply of infant formula in the United States, and stocks are now slowly increasing. But progress has been slow. An HHS official told health care providers and parents during a call hosted by the White House on June 23 that the administration’s “Operation Fly Formula” airlifted 1 million pounds of powder of infant formula in the country on that date.
He acknowledged, however, that that’s only a few days of formula consumed in the United States, where families consume an average of 4 million pounds of formula powder per week.
The HHS official also told people on the call that the administration was working to import more of the special metabolic formulas that Abbott previously made at its Sturgis plant, but they were having trouble finding supplies. . The administration has secured several thefts of specialty formulas so far, but not of the most specialized types.
“We are months – months – away from the end of these shortages,” one person who was on the call told POLITICO.
The administration is struggling to understand how much formula is actually on the shelves and has acted in recent weeks to get better data, as POLITICO reported.
Other challenges have limited the impact of the government’s import strategy: the majority of formula brands coming from overseas to the United States do not have distribution networks already in place to supply stores, forcing foreign companies to sell these products instead. on line. This locked in a huge share of the US market, including low-income mothers and babies who use WIC benefits to purchase formula. These benefits cannot be used to buy formula milk online.
“It doesn’t reach us,” said a mother from Raleigh, North Carolina, who uses WIC benefits to buy formula. “I’m really glad they’re doing all this work, but our store shelves are still pretty empty and it’s July.”
“It’s no use to us if it’s available online,” the mom added.
Amid ongoing shortages, the Biden administration announced this week that the FDA is working on a plan to extend temporary measures that have allowed more foreign companies to import infant formula into the U.S. beyond the initial expiration in November. Formula company officials and nutritionists thought the step was inevitable amid the need for supply.
The FDA said the import move and other planned moves would help diversify the hyper-consolidated U.S. infant formula industry, which is dominated by Abbott and three other companies. The decision to streamline the process also signals that the Biden administration is addressing the fact that shortages could last much longer than in November, while also trying to strengthen the supply chain against future shocks by adding new permanent suppliers.