Three people familiar with the conversations, including a Biden administration official, say that early last month, around July 7, Abbott began shipping EleCare produced in its Sturgis facility after the February recall. It’s the first formula produced at the plant since the company shuttered 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 plant, which was estimated to manufacture about one-fifth of the nation’s infant formula supply at the time, triggered national shortages that have continued to drag on in some 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 order and aren’t sold in regular retail stores — directly to parents and caregivers on an emergency basis, at the request of their physicians. The initial shipments were comprised of formula produced before the Sturgis plant shuttered, but wasn’t part of the recall. But Abbott spokesperson John Koval confirmed some of the cases shipped in recent weeks have included formula produced during a period in June when the plant briefly restarted, before shuttering again after heavy storms triggered flooding in the facility.
It wasn’t clear to some medical providers and families that the EleCare they’re now receiving was produced after the recall. “I assumed that was the case, but we haven’t gotten a lot of updates,” said one health care provider in Georgia.
Koval said in a statement that the formula that’s been shipped out from that June period “had already been produced, stored and rigorously tested.”
As POLITICO first reported, Abbott quietly restarted production a second time on July 1. None of the formula produced since then has yet been shipped to retailers or families, Koval said. But he did confirm that Abbott has restarted the production of metabolic formulas, an even more specialized category of formula than EleCare that is normally produced at the Sturgis plant.
And speaking on the company’s July 20 second-quarter earnings call, 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 put out an exact date here,” Ford told investors on the call. “But we’re not talking months, we’re not talking weeks. So, we’re very close there and we obviously have a team that’s ready to go.”
FDA Commissioner Robert Califf told lawmakers in May that he expected supplies to “be beyond normal, and with a plethora” by the end of July. He recently declined to provide an updated timeline for formula supplies to normalize.
“Like a plane taking off, I would expect to see a gradual improvement in the shelves,” Califf told a Senate Appropriations subcommittee on July 20. “It’s not going to be a sudden fix.”
The comments were cold comfort to parents who have been scrambling for months to find formula to buy, especially those with children who have gastrointestinal issues or severe food allergies and rely on EleCare or other specialty formulas to survive.
“I’m hoping and praying that there will be some relief, but so far it doesn’t seem likely,” said Serenity Rodgers, a 19-year-old single mom of infant twin girls who live in a suburb of Kansas City, Missouri.
Rodgers has struggled to find formula ever since her daughters were born — just days after the Abbott recall in February. The girls were quickly diagnosed with a milk allergy and put on EleCare by their doctor. She’s eligible to use federal WIC benefits to buy EleCare formula, but supplies have been hard to come by through the WIC program or at medical supply stores, the few places it’s available.
Rodgers has found herself having to pay out of pocket, sometimes $80 for what is normally a $55 can of formula, and the twins are “formula hopping” between brands trying to find something their bodies can tolerate. Rodgers has also received twelve free cans of EleCare that her doctor requested from Abbott, which she said was helpful, though they went through the supply pretty quickly. She wasn’t aware it was likely formula produced after the recall.
Health care providers have said they need as much information from Abbott as possible about how the new formula was produced at Sturgis and how much testing it’s gone through before it reaches families. Some families are desperate for supplies and aren’t concerned about any possible contamination risks, while others don’t ever want to use Abbott formula again, said one Virginia health care provider, who has been trying to find formula supplies for medically-vulnerable children for months. “We just need to give them all the information so they can make a decision,” the provider added.
The person said the crisis has shaken their trust in Abbott. But they’re also disappointed the shortages, especially of specialty formulas, have worsened in her region after feeling like there was “a light at the end of the tunnel” in May, after the Biden administration announced it would use U.S. military flights to import formula, among other steps.
When providers and others desperate for updates have reached officials from the White House Office of Public Engagement and elsewhere across the administration in recent weeks, Biden officials have often emailed back press releases about weeks-old actions. A White House official noted the White House and FDA have held a series of calls for medical providers and other stakeholders during the shortages. The administration also has taken steps that aim to increase competition in the infant formula market long-term and the Agriculture Department recently announced it would extend key WIC flexibilities for another month, which providers note is a positive step.
A White House official told POLITICO in June that, “ultimately, it is going to be up to Abbott to end this shortage.”
An FDA spokesperson declined to say whether Abbott had told the agency before it began shipping out formula produced at the Sturgis plant since the February recall. Under a consent decree with the FDA and Department of Justice, Abbott is required to take additional food safety and testing steps, and is also required to alert the FDA if there is a new case of the 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 reinspect 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 the formula shortages linger. On the July 20 call with investors, Ford said Abbott was investing in brand recovery, which he described as “necessary to get our [market] share back in position that we need as we go into next year.”
Abbott employees, including regional pediatric representatives for the company who deal with their infant formula business, have continued hosting dinners with physicians and dietitians to repair relations over the last 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 providers has been mixed.
“We were supposed to have this great meal, while the children we were taking care of didn’t have food to eat,” said one provider who turned down an invitation. “The contrast of that was just so horrifying to me.”
Soruce : https://www.politico.com/news/2022/08/04/abbott-plant-shipping-out-first-baby-formula-produced-since-recall-00049627