Infant formula stockpile for the U.S. suggested by FDA chief

WASHINGTON — The U.S. government should consider creating a stockpile of infant formula to avoid 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 an initiative after the current crisis is relieved.

“The big question that, I think, is going to have to be addressed is, do we create a stockpile as a backup in case something doesn’t work in the future,” Califf said.

In about two months, Califf said, he expects infant formula manufacturers will begin to produce a surplus. At that time, the federal government will need to decide if it wants to “maintain that surplus as a government activity for the foreseeable future.”

He and lawmakers did not discuss whether a stockpile would need congressional approval.

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

In the five months leading up to the plant shutdown, the FDA received a whistleblower report about unsanitary conditions at the facility, four infants became ill with Cronobacter infections, with at least two of them dying, and an FDA inspection of the facility in late January found several violations.

Among the issues at the Abbott infant formula facility were

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

No evidence of malfeasance

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

He repeated that statement Thursday while testifying before the U.S. Senate Health Education, Labor and Pensions Committee.

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

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

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

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

He then said the FDA has a plan to address those issues, but when pressed by Murray about sharing the plan with Congress, Califf said he couldn’t give her an exact date for when FDA could share the plan since it’s not written down.

Supply chains

In addition to suggesting U.S. lawmakers and the FDA consider creating an infant formula stockpile, Califf said his agency needs better insight into the different infant formula manufacturers’ supply chains.

At the moment, Califf testified, infant formula manufacturers are not required to tell the FDA when they have an impending shortage, or when they find contamination in a sample at their facility that has not yet been shipped out. The companies are also not mandated to have a back-up plan, or a contingency plan to avoid a shortage if the plant goes offline.

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

If the “FDA had insight into the supply chains and how they fit together,” Califf said, “the likelihood we would need the stockpile would be quite low.”

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