WASHINGTON, D.C. — At a meeting Thursday to address a nationwide shortage of baby formula, FDA Commissioner Robert Califf said the nation was still weeks away from returning to normal supplies of the essential product.
“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,” he said. "As a parent and grandparent I recognize that many parents and caregivers have been unable to access the infant formula and critical medical foods that they need, and they are understandably frustrated and anxious.”
The shortage, which experts say has existed for months in the U.S., was heavily exacerbated by a recall issued by Abbott Nutrition
The recall was issued by the FDA in February, after four children in three states fell ill and two of them died. Abbott issued a voluntary recall of certain products and shut down their facility in Sturgis, Michigan, badly disrupting the supply of formula. The federal government later closed down the facility entirely after discovering Abbott had violated safety and sanitary procedures in Sturgis.
“This crisis has shown us the impact of having a single manufacturer cease production for a brief period, and unless we strengthen the resilience of our supply chain, we could be one natural disaster, quality mishap or cyber-attack from this happening again,” said Califf.
The FDA has already faced criticism from lawmakers over their inability to address the brewing situation, even before the Abbott recalls.
“I don’t think we should be giving ourselves too many kudos here because I wish this hadn’t happened in the very beginning,” said Senator Debbie Stabenow, (D) – MI, who sponsored a bill that passed this week meant to aid moms on government assistance obtain formula. “We shouldn’t have seen what happened at the Abbott Plant and in my mind, the FDA should’ve moved more quickly.”
“FDA was not aggressive enough to go and make sure that formula factory was doing what it needed to do to make sure that families could purchase formula that was safe, to get it reopened, to work with them,” said Sen. Patty Murray, (D) – Washington. “It was just like, nobody did their job here."
This week, President Joe Biden invoked the Defense Production Act so manufacturers of formula could get it to the distributors who need it most. The White House also authorized the Pentagon to begin using commercial airliners to fly in formula from other nations. It would be subject to safety and quality testing once it arrives in the U.S.
“I want to be clear,” said Califf, “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."
Michigan lawmakers want this all looked at closely, so stocks of imperative formula don’t run low again.
“We need to look at this as not just a checkers move; this is a chess move,” said Rep. Bill Huizenga, (R) – Michigan. “What are the next couple of moves that need to be made? And that is helping these companies, especially when we have constrained production and shortages like this, to then move as rapidly and safely as possible to get them back online.”
