FDA, Abbott Nutrition, face tough questions on formula shortage
FDA Commissioner Dt. Robert Califf testified about the infant formula shortage Wednesday before a House subcommittee.
Califf was fiercely questioned by lawmakers on both sides of the aisle about the FDA's slow response to the crisis.
The FDA did not obtain bacteria samples from a Sturgis, Michigan baby formula plant for months after the first reports of bacterial infections in infants were linked to the plant.
Califf acknowledged missteps by the FDA leading to a slower-than-ideal response. He said inspections revealed shocking conditions at the Abbott plant, including standing water on floors and staff not following hygiene protocols.
"This is so far removed from our previous experience with the company that I am very concerned," he said.
Califf said the U.S. infant formula industry is not diversified enough, with the Sturgis plant producing a large amount of the domestic supply.
He also referred to his agency's request for new funding from Congress, in order to develop a digital supply chain tracking system and additional staff to go along with it.
Such a tracking system could address regional issues with shortages that came to light after the Sturgis plant shut down, to make sure all parts of the country are equally supplied with infant formula.
Chris Calamari, a top executive at Abbott Nutrition, also testified. He called the shortage of formula "heartbreaking."
"On behalf of everyone at Abbott, I want to express our extraordinary disappointment about the shortage," he said. "We are deeply, deeply sorry and we are committed to ensuring that this never happens again."
The crisis began when several infants were infected by bacteria, and two of them died. The same bacteria was later detected at Abbott's Sturgis, Michigan plant, but Abbott says there is no conclusive evidence to link its formulas to the illnesses.
Abbott and the FDA closed the plant on February 17th, that plus a recall caused a national shortage of formula. Other baby formula companies worked to increase production of their formula products.
Last week, President Joe Biden invoked emergency powers under the Defense Production Act to boost production of baby formula and ordered government agencies to use commercial flights for imports to alleviate shortages.
The Abbott Nutrition plant in Sturgis is scheduled to reopen in early June. The plant is operating under a consent agreement with the FDA.