WASHINGTON, D.C. – The FDA Commissioner was in the hot seat at a congressional hearing over the infant formula shortage. He also reveals unsanitary problems they found with one formula manufacturer’s facility that ultimately led to its shutdown.
“The fact that babies across the country are going hungry and parents cannot find what they need to feed their infants is a massive unacceptable failure,” said Sen. Patty Murray (D- WA).
Congressional members on both sides of the aisle did not hold back on the infant formula shortage in a recent hearing. Pointing the finger at the FDA and formula manufacturers for not responding quickly enough even though they say there were warning signs.
In February, Abbott, one of the largest formula manufacturers, closed their Michigan plant and recalled multiple baby formula products after the FDA found five different strains of a bacteria that can cause dangerous blood infections at the facility. Manufacturers told lawmakers the pandemic already strained formula supply chains and shortages began last year. During this hearing, the FDA Commissioner, Robert Califf, said their inspection results were shocking.
Califf said their review of Abbott’s formula plant in Michigan was unacceptably unsanitary, fnding cracks in key equipment, the roof leaking, bacteria growing from multiple sites in the facility, standing water and even inadequate handwashing.
“The need to take urgent action to protect the most vulnerable people, our infants, presented a dilemma,” said Califf. “This was the largest plant of the dominant manufacturer and it was the sole source of metabolic formulas which are essential for viability of infants with no substitution possible because Abbott had no backup plan. We knew that ceasing plant operations would create supply problems but we had no choice given the unsanitary conditions.”
But members want to hold the FDA accountable.
“Yesterday in testimony to the House you tried to shift the blame,” said Sen. Richard Burr (R- VA). “The mailroom didn’t deliver whistleblower complain, it’s your mailroom and the FDA knew there was a problem even before the whistleblower sent the letter.”
In the FDA’s testimony, they said Abbott assured them their plant would be up and running again in early June. Until then, formula from outside of the U.S. is being flown in and other manufacturers are being asked to step up production.