The Food and Drug Administration will accelerate its review of the agency’s food regulatory functions in the wake of the infant formula shortage that has prompted severe criticism of FDA’s ability to react quickly to emergency situations.
FDA Commissioner Robert Califf told a House panel Wednesday he had planned to conduct a review of the food program within six to nine months of his Feb. 18 confirmation, but because of the formula crisis, “we’ll move [the review] up.”
“My basic plan has been to get through this crisis and then we will be looking at the overall food program from the perspective of reforming it,” he said.
In addition, he said, “We definitely need a stronger team at the higher levels on the food side as part of the revamping of the entire foods program.”
In February, major infant formula manufacturer Abbott Laboratories shut down its plant in Sturgis, Michigan, and recalled some of its formula after FDA found Cronobacter contamination at the facility Four infants have been sickened and two died after consuming Abbott formula, and FDA says “Cronobacter infection may have contributed to the cause of death for both patients.”
Abbott maintains there is no “conclusive evidence” that its formula caused the illnesses or deaths, but at the hearing, Califf said FDA can’t rule out that possibility either, "as the confluence of events is highly unusual."
FDA’s inspection of the Sturgis plant revealed “egregiously unsanitary” conditions, Califf said. He added that he expected Abbott to have the plant up and running by June 4.
The hearing Wednesday before the House Energy and Commerce’s Committee’s Subcommittee on Oversight and Investigations featured plenty of criticism of FDA, including why a whistleblower report sent by an Abbott employee to FDA in October was not seen by top FDA food safety officials until February.
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The Washington Post reported on the delay Wednesday, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas confirmed it at the hearing. In an interview with the Post, Yiannas said, “It wasn’t sent to me and it wasn’t shared with me internally. How does this happen? There were early signals and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”
Yiannas said at the hearing he did not know he was talking to a reporter, although the Post said in its article that he was returning a reporter’s voice mail in which she had fully identified herself and her organization.
At the hearing, Yiannas accused the Post of “very unethical and egregious behavior” but did not dispute any of the facts in the article.
Califf told the subcommittee that “this particular issue, as I've stated before, is a significant process issue of escalation criteria within the organization, which we have now fixed.” He conceded that FDA’s response was “too slow,” adding that “there were decisions that were suboptimal along the way.”
Lawmakers said it’s important for FDA not to shortchange food safety and questioned whether the agency’s organizational structure and its current resources allow it to respond quickly to emergencies.
“We have to work together … to put ‘food’ back into the Food and Drug Administration,” said subcommittee Chairwoman Diana DeGette, D-Colo. “We have to not just throw money at it.”
Califf agreed, saying the medical product side of FDA is operating well and that “the food side needs a similar shot in the arm.”
He also said it’s important to get more information from companies to avert similar supply shortages in the future.
In his written testimony, Califf backed “a digital platform that monitors the supply chain constantly and in real time.
“This industry and most others have been resistant to efforts to develop such a system, but until such steps are taken, the American public will be vulnerable to threats from natural disasters and cyberattacks as well as the quality problem that created the current infant formula situation."
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