WASHINGTON — The U.S. government should consider creating a stockpile of infant formula to head off the possibility of future shortages, the head of the U.S. Food and Drug Administration told a Senate committee on Thursday.

Commissioner Robert Califf said during his third hearing on Capitol Hill about the months-long shortage that his agency and lawmakers really need to consider such a move once the current crisis eases.

“The big question that I think will have to be answered is whether we create a backup stock in case something doesn’t work in the future,” Califf said.

In about two months, Califf said, he expects infant formula makers to start producing a surplus. At that point, the federal government will have to decide if it wants to “maintain this surplus as a government business for the foreseeable future.”

He and lawmakers did not discuss whether a stock would require congressional approval.

The current infant formula shortage began in mid-February after Abbott Laboratories issued a recall of products made at its plant in Sturgis, Michigan.

In the five months before the plant closed, the FDA received a whistleblower report of the facility’s unsanitary conditions, four infants fell ill with Cronobacter infections, at least two of whom died , and an inspection of the facility by the FDA in late January found several violations.

Problems faced by Abbott’s infant formula plant include

  • Backwater.
  • Cracks in key equipment that could have allowed bacterial contamination to persist.
  • Leaks in the roof.
  • Previous citations for improper hand washing.
  • Bacteria growing from multiple sites.
  • “A disappointing lack of attention to safety culture.”

No evidence of wrongdoing

Califf testified before a U.S. House committee on Wednesday that he had so far found no evidence of intentional delay or malfeasance at the FDA, despite the slow response.

He repeated that statement on Thursday during his testimony before the US Senate Committee on Health Education, Labor and Pensions.

Democratic Washington Senator Patty Murray, chair of the panel, said the fact that she had to hold the hearing, the fact that store shelves continue to be empty and the fact that babies across the country are hungry represented a “massive and unacceptable failure”.

Ranking member Richard Burr, a Republican from North Carolina, said it was time for Congress to “hold the FDA to account.”

“It’s a sad story about the FDA’s unwillingness and inability to do its job,” Burr said.

Califf testified that “there are systemic issues at the FDA and in our interactions with industry and our authorities that need to be addressed.”

He then said the FDA had a plan to address these issues, but when Murray pressed him to share the plan with Congress, Califf said he couldn’t give him an exact date when the FDA could share. the plan because it is not written.

supply chains

In addition to suggesting that U.S. lawmakers and the FDA consider creating an infant formula stockpile, Califf said his agency needed to better understand the supply chains of different infant formula manufacturers.

Currently, Califf said, infant formula makers aren’t required to notify the FDA when they have an impending shortage or when they discover contamination in a sample from their facility that hasn’t been tested. yet been shipped. Companies are also not required to have a back-up or contingency plan to avoid a shortage if the plant shuts down.

“If this plant had been hit by a tornado, instead of a quality issue, the same issue would be in front of us now,” Califf said.

If the “FDA had some insight into the supply chains and how they fit together,” Califf said, “the likelihood of us needing the stock would be quite low.”

“Between storage and having a resilient system, we should be able to prevent this from happening again,” Califf said.

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