U.S. infant formula makers are revving up production and the door is open to imported formula, so “we should see improvement in a matter of days” from shortages nationwide, FDA commissioner Robert Califf said Thursday on Capitol Hill. Califf also said he would strengthen food safety procedures at the agency, though key lawmakers argued he was not going far enough.
Califf, speaking at a House Appropriations Committee hearing, promised improvement would come quickly, though he acknowledged that “it will be a few weeks before it gets back to normal.”
He listed three reasons that shortages will ease: U.S. formula manufacturers have stepped up production; operations will resume soon at a mammoth Abbott Nutrition plant in Michigan; and the administration is encouraging imports of formula and ready to fly it to America to speed up deliveries. The plant in Sturgis, Michigan, accounts for one-third of production for Abbott, which sells 43 percent of infant formula in the country.
Meanwhile, the Senate passed on a voice vote and sent to the White House a bill to give administrators of the Women, Infants, and Children (WIC) program more flexibility to provide infant formula to participating households during emergencies, such as the current shortage. The House passed the bill, HR 7791, on a 414-9 vote on Wednesday night. A companion bill, HR 7790, which would give the FDA $28 million to ensure the safety of infant formula, may be called soon for a Senate vote.
House Appropriations chair Rosa DeLauro of Connecticut faulted the FDA for “a disgraceful lack of oversight” at the Sturgis plant, which suspended production after FDA investigators found bacteria at the facility that can cause foodborne illness. The FDA did not inspect the plant until months after a whistleblower disclosed safety shortcomings at the plant, and there were reports of illnesses among infants who consumed formula from the plant. A link between the plant and the sick babies has not been proven.
Califf, who headed the FDA during the final year of the Obama era, agreed with criticism that food plays second fiddle to drugs and medical devices at the agency. “I was very aware coming in [this year] that we need to do major improvements on the food side of FDA,” he said.
DeLauro said Califf ought to appoint a deputy commissioner for food, with jurisdiction over all of the FDA’s food safety work. “This should happen immediately,” said DeLauro. “And the person who is appointed needs to have relevant and appropriate food credentials.” At present, the two major FDA wings devoted to food safety have separate leadership.
Califf took a different approach. He said that Janet Woodcock, FDA principal deputy commissioner, would provide “strategic counsel” to the agency’s food safety divisions, including the Center for Food Safety and the Center for Veterinary Medicine. Woodcock was the acting commissioner when problems were first reported at the Abbott plant in Michigan.
“What can we expect from this action, to improve the operations?” asked Rep. Sanford Bishop, a Georgia Democrat. Rep. David Valadao, a California Republican, said the FDA, after seeming to not take complaints about the Michigan plant seriously, needed to “ensure the shortage is fixed immediately.”
“This is just the start of a change,” said Califf. “We will make other changes that you will hear about over time.”
Also on Thursday, the White House approved the first mission under Operation Fly Formula, a USDA request to transport Nestlé formula from Switzerland to Plainfield, Indiana. The formula is for babies allergic to cow’s milk. The Defense Department “is actively working to identify commercial aircraft,” said the White House.
To watch a video of the House hearing, click here.