Abbott Laboratories, whose recall of infant formulas made at a Michigan plant has been widely blamed for a nationwide shortage, announced Monday it had reached an agreement with the Food and Drug Administration on the steps needed to restart production — but it will still be weeks before any formula hits store shelves.
Abbott also claimed in its announcement that the Centers for Disease Control and Prevention had found no “conclusive evidence” linking formulas made at its Sturgis, Mich. facility to the infant illnesses and deaths that triggered the initial recall in February.
Once a court signs off on the deal and the FDA gives the go-ahead to reopen the problem-plagued facility, Abbott could restart formula production within two weeks — though it will still be six to eight weeks before its products become publicly available.
Details of the agreement, known as a consent decree, were not immediately disclosed.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” Abbott chairman and CEO Robert B. Ford said in a statement. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
“We’ve been working closely with Abbott, as you might imagine, since the plant was closed voluntarily based on the findings of inspections and we now have a path forward,” FDA Commissioner Robert Califf told NBC’s “Today” Monday morning.
“Of course, Abbott is responsible for the timeline,” Califf added, “but I’m very comfortable with what they said about two weeks.”
Califf noted there would be a “full investigation of the timeline” and vowed the agency will work to ensure the same mistakes aren’t repeated again.
“We always want to be as fast as we can possibly be while also being diligent, remembering — as shown by this example — that if we do close a plant, then we have a supply shortage,” Califf said. “So, we have to get this right.”
In February, four babies became ill — two of them fatally — with bacterial infections after drinking formula made at the Sturgis plant, leading the company to voluntarily recall products made at the facility while the FDA and CDC conducted an investigation.
Abbott said it plans to start making EleCare, Alimentum and metabolic formulas first before resuming production of Similac and other formulas once production gets back underway.
