Three people familiar with the conversations, including a Biden administration official, say that early last month, around July 7, Abbott began shipping EleCare produced at its Sturgis plant after the February recall. It’s the first formula produced at the plant since the company closed the facility in mid-February after FDA inspectors detected strains of a bacteria that can be deadly to babies. The shutdown and recall of much of the formula produced at the factory, which was estimated to make about a fifth of the nation’s infant formula supply at the time, triggered nationwide shortages that have continued to drag on in parts of the country, despite the Biden administration’s emergency measures.
Since late April, Abbott has been shipping free cases of some of its specialty formulas – which normally require a doctor’s prescription and are not sold in regular retail stores – directly to parents and caregivers in emergencies, at the request of their doctors. Initial shipments were made up of formulas produced before the Sturgis plant closed, but were not part of the recall. But Abbott spokesman John Koval confirmed that some of the cases shipped in recent weeks included formulas produced during a period in June when the plant briefly restarted, before closing again after many heavy storms triggered flooding at the facility.
It was unclear to some medical providers and families that the EleCare they are currently receiving was produced after the recall. “I assumed that was the case, but we haven’t received many updates,” said a health care provider in Georgia.
Koval said in a statement that the formula that shipped from this June period “has already been produced, stored and rigorously tested.”
As POLITICO first reported, Abbott quietly restarted production a second time on July 1. None of the formulas produced since then have yet been shipped to retailers or families, Koval said. But he confirmed that Abbott had restarted production of metabolic formulas, an even more specialized category of formulas than EleCare which is normally produced at the Sturgis plant.
And speaking on the company’s second-quarter earnings call on July 20, Abbott CEO Robert Ford said the Sturgis plant was “very close” to restarting production of Similac, the company’s general formula product, which can be purchased at retail stores.
“I don’t necessarily want to give an exact date here,” Ford told investors on the call. “But we’re not talking about months, we’re not talking about weeks. So we are very close there and obviously we have a team that is ready to go.
FDA Commissioner Robert Califf told lawmakers in May that he expected supplies to be “beyond normal and bloated” by the end of July. He recently declined to provide an updated timeline for standardizing prep supplies.
“Like an airplane taking off, I would expect to see a gradual improvement in the spokes,” Califf told a Senate appropriations subcommittee on July 20. “It will not be a sudden solution.”
The reviews were of little comfort to parents who have been scrambling for months to find a formula to buy, especially those whose children have severe gastrointestinal issues or food allergies and who rely on EleCare or other specialty formulas. to survive.
“I’m hoping and praying there’s some relief, but so far it doesn’t seem likely,” said Serenity Rodgers, a 19-year-old single mother of toddler twins who lives in a suburb of Kansas City, Missouri.
Rodgers has struggled to find formula since her daughters were born, just days after Abbott’s recall in February. The girls were soon diagnosed with a milk allergy and put on EleCare by their doctor. She is eligible to use federal WIC benefits to purchase the EleCare formula, but supplies have been difficult to find through the WIC program or at medical supply stores, the few places it is available.
Rodgers found herself having to pay out of pocket, sometimes $80 for what is normally a $55 box of formula, and the twins are “formula jumping” between brands trying to find something their bodies can tolerate. . Rodgers also received twelve free cans of EleCare that her doctor requested from Abbott, which she says was helpful, although they ran through the supply fairly quickly. She didn’t know that it was probably a formula produced after the recall.
Healthcare providers said they needed as much information as possible from Abbott about how the new formula was produced at Sturgis and how many tests it underwent before it was released. reach families. Some families are desperate for supplies and don’t worry about possible contamination risks, while others don’t want to use the Abbott formula ever again, said a Virginia healthcare provider, who has been trying to find preparedness supplies for medically vulnerable children. During months. “We just need to give them all the information so they can make a decision,” the supplier added.
The person said the crisis had shaken his confidence in Abbott. But they are also disappointed that shortages, especially of specialty formulas, have worsened in his region after it felt like there was “a light at the end of the tunnel” in May, after the Biden administration announced that it would use US military flights to import formula, among other steps.
When vendors and others desperate for updates have reached out to officials in the White House Office of Public Engagement and elsewhere in the administration in recent weeks, Biden officials have often fired back. e-mail press releases on stocks that are several weeks old. A White House official noted that the White House and the FDA have held a series of calls for medical providers and other stakeholders during the shortages. The administration has also taken steps to increase competition in the long-term infant formula market and the Department of Agriculture recently announced it will extend key WIC flexibilities by one month, which suppliers see it as a positive step.
A White House official told POLITICO in June that “ultimately it will be up to Abbott to end this shortage.”
An FDA spokesperson declined to say whether Abbott notified the agency before it began shipping formula produced at the Sturgis plant since the February recall. Under a consent decree with the FDA and the Department of Justice, Abbott is required to take additional food safety and testing measures, and is also required to alert the FDA if there is a new case. of Cronobacter sakazakii – the bacteria found at the Sturgis plant in February – or salmonella. The company is also required to keep detailed records of where any newly produced formula from the Sturgis plant is shipped. But the FDA is not required to re-inspect or test the facility or any formula before new supplies are sent to stores or medical supply stores.
Meanwhile, the company is slowly trying to rebuild its image with families and the medical community, even as formula shortages persist. During the July 20 call with investors, Ford said Abbott was investing in reclaiming the brand, which he described as “necessary to get our [market] share the position we need as we approach next year.
Abbott employees, including the company’s regional pediatric representatives who look after their infant formula business, have continued to host dinners with doctors and dietitians to restore relationships over the past few months.
“We communicate regularly and transparently with our customers because their opinions matter and are important to us,” Abbott’s Koval said in response.
But feedback from vendors has been mixed.
“We were supposed to have this good meal, while the children we were caring for had nothing to eat,” said one provider who declined an invitation. “The contrast of that was so horrifying to me.”