An Abbott plant in Michigan that closed in February due to possible contamination could reopen in one to two weeks, Food and Drug Administration Commissioner Robert Califf told lawmakers on Thursday.
Califf testified to House Appropriations Committee as lawmakers questioned him on the infant formula shortage occurring throughout the U.S. The Abbott plant’s closure has been cited among the reasons for a shortage in formula.
"We had to really wrestle this to the ground with Abbott ending up in a consent decree with the Justice Department to make sure as we bring the plant up, both the FDA inspectorate and external experts are watching every step of the way,” he said. ”And I'm pleased to say today we've already made significant progress, and I think we are on track to get open in the next week to two weeks, most likely at the outer bound two weeks."
Abbott said there was no evidence of contaminated infant formula originating from its plant. However, Abbott said it could be weeks before production is back to where it was before closing.
Abbott issued a recall and closed the facility after two infants died and two others were treated for cronobacter. Abbott said cronobacter was discovered in the plant, but not in areas that would come in contact with the formula.
Meanwhile, the FDA is working on allowing foreign-made formula to enter the U.S. market.
"This week we set up a mechanism that streamlines the abilities for companies that do not normally sell infant formula in this country to do so and provides other flexibilities to domestic distributors who can help increase availability,” Califf said. "I want to be clear--under this process an infant formula would only be imported after the agency reviews the product and determines the product is safe and provides adequate nutrition. Safety is paramount."
While he said the FDA is “working tirelessly” to end the shortage, Califf said the U.S. is one disaster away from this shortage happening again.
