Food and Drug Administration Commissioner Robert Califf admitted to members of Congress Thursday that a resolution to the nationwide baby formula shortage is still “a few weeks away” as the Biden administration grapples with the ongoing crisis.
Under questioning from Rep. Julia Letlow (R-La.), Califf suggested that the shortage would improve “within days,” adding that “we have sold — we have had more infant formula bought by between 11 and 19% than what was bought in the month before” the closure of an Abbott Nutrition factory in Michigan that has been blamed for the crisis.
“So I can tell my constituents that within a matter of days, they’ll be able to find formula on the shelves?” Letlow asked.
“It will gradually get better. You know the big problem we have right now is distribution,” the commissioner said before adding that “within days it will get better. But it will be a few weeks before we’re back to normal.”
Califf appeared before the House Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies to go over the FDA’s budget request for FY 2023, However, the focus of the hearing was why the agency did not act faster to prevent the formula shortage.
Food and Drug Administration Commissioner Robert Califf suggested that the baby formula shortage would improve “within days.” Ting Shen/Xinhua via Getty ImagesIn her opening statement, Appropriations Committee Chair Rosa DeLauro (D-Conn.) accused agency officials of “dereliction of duty” by failing to immediately look into a whistleblower complaint about improper procedures at the Abbott facility in Sturgis, Mich.
“The FDA knew about what Abbott was doing in October,” DeLauro said of claims the company was falsifying records, failing to adequately clean the plan and releasing untested formula, “but it was not until late December that the FDA interviewed the whistleblower. And then, not until a month after that –late January — was the plant inspected in person. Abbott then issued a recall in February, some four months late.”
DeLauro also slammed the FDA for only releasing safety “guidance” for approved manufacturers, instead of requirements.
Parents have been left scrambling to buy various name-brand instant baby formula since the closure of Abbott’s Sturgis, Mich., plant. JIM WATSON/AFP via Getty Images“You don’t have in place a mechanism that would guarantee the safety right now, you just don’t,” she told Califf. “That guidance does not allow you to determine and to define the safety of the products that may be coming from facilities that are not FDA-approved.”
Rep. Mark Pocan (D-Wis.) also swiped at the agency during his line of questioning, accusing it of failing to provided detailed information about the Abbott investigation.
“You can talk about it anonymously. You should talk about it [publicly],” Pocan said. “One problem I’ve seen over and over with the FDA in my 10 years here is you guys aren’t good at communicating. And, you know, this is something parents are asking us about, they want to know what happened. You all gotta get that down to explaining in a way that real people can understand. I understand there’s a science behind it. But it’s not acceptable to say that you can’t comment on it.”
During a second round of questioning, DeLauro revisited the transparency issue, telling Califf “you can’t hide behind an investigation.”
“We need answers. We need them now,” she continued. “Who received this report? What did they do with who was heading the FDA at that time? My understanding is that the acting commissioner was Janet Woodcock, what did she know about this? So who was handling all of this and was this report lent to the FDA and investigated?”
“Well, as I’ve said, you’ve got the timeline down and you’ve got the key issues. I know we have an oversight hearing next week [May 25]. And we’ll be prepared to go into much more detail at that point,” Califf responded. “And you know, as I’ve said, we could do better than we did.”
“Oversight committee next week,” DeLauro interrupted. “You’re before the committee that funds what you do. So this information is relevant to this subcommittee of appropriations.”
“I appreciate what you’re saying that — the investigation is not completed yet. And so I’m not in a position to answer specifics like that,” Califf hedged.
DeLauro then ripped Califf for his lack of response.
It will be weeks before the Abbott manufacturing facility in Sturgis, Michigan, will be able to put product on the shelves again. JEFF KOWALSKY/AFP via Getty Images“You have no idea who received the document — physically received the document,” she said. “Where did it go? Or read it? What was the chain of command? You apparently don’t have any answers to that question. That is indicative of again, not responding to the seriousness of this issue. That says it all.”
During a media round earlier this week, the commissioner first posited that the issue is not a lack of baby formula, but problems with distribution.
“I don’t want this to sound in any way like we’re not concerned about the parents that are struggling to find formula for their children. That’s definitely happening in parts of the country,” he told CNN on Monday before insisting “there is formula out there.”
“But you know, the number of stock on shelves is about 90% before … the recall, and it dropped to about 79% at its lowest, and we’re on the way back up now.”
The hearing took place just one day after President Biden agreed to invoke the Defense Production Act to ensure formula producers can acquire the necessary material to put the product back on the shelves.
Parents have been left scrambling to buy various name-brand instant baby formula since the closure of the Abbott plant
The company said this week it had reached an agreement with the FDA on necessary steps before the facility can reopen. However, even after the agency gives the green light, it will take up to two weeks for formula production to restart and up to eight weeks before the product can hit the shelves.
When pressed on communication between the Michigan facility and the FDA, Califf revealed Thursday that he is receiving a progress report twice a day on the plant’s status.
To immediately resolve the shortage, the Biden administration is seeking help from abroad, unveiling what it called Operation Fly Formula to ferry product into the US after the FDA eased import rules.
The Biden administration has been facing increasing criticism as the shortage continues – with the president drawing heat for telling reporters Friday that authorities could only have dealt with the situation more effectively “if we’d been better mind-readers, I guess.”







