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Republicans demand explanation for FDA’s delayed reaction to baby formula shortage

FIRST ON FOX: Two House Republicans on Monday called on the Food and Drug Administration to explain why it took so long for the agency to react to shortages of baby formula around the country this year, and what steps it’s taking to ensure it doesn’t contribute to future supply shocks.

Reps. Brett Guthrie, R-Ky., and Morgan Griffith, R-Va., told FDA Commissioner Robert Califf that the agency still suffers from problems that created the baby formula crisis, which forced the Biden administration to facilitate the import of hundreds of thousands of pounds of formula. On Friday, the Biden administration announced its 24th Fly Formula mission to import 63,000 pounds of formula from Nestle, and it has imported nearly 91 million pounds of formula so far.

The shortage was caused by an FDA inspection and subsequent shutdown of the Abbott Nutrition plant in Michigan, and the two lawmakers said FDA needs to do a better job understanding how its actions affect the market.

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“Within the past year, the Office of Food Policy and Response and CFSAN [FDA’s Center for Food Safety and Applied Nutrition] has been engulfed in controversy because of its botched response to reported safety issues at a major baby formula manufacturing facility, causing a dangerously low supply of infant formula across the United States that is still ongoing,” they wrote.

Guthrie and Griffith were most critical of the length of time it took for FDA to launch an investigation into whether the Abbott plant was the source of bacteria that is dangerous to infants, and its inability to recognize the supply shortage this action took. Abbott has said the investigation has found no link between its plant and bacteria that sickened two infants and led to the death of two others.

Lawmakers said the first complaint of a possible link between the plant and the bacteria was filed in September, but the FDA didn’t get to inspect the Abbot plant until the end of January. They also said a whistleblower tipped the FDA off to a possible problem, but that information wasn’t relayed up the chain in time because of what FDA said were shortages in its mailroom due to the COVID-19 pandemic.

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“[T]he agency’s failure to act sooner to immediately address the imminent crisis, despite having multiple warning signs, represents a fundamental breakdown in regulatory decision-making creating undue uncertainly in a supply chain that has been strained throughout the COVID-19 pandemic and leaving parents wondering how they will feed their children,” they wrote.

In light of these problems, the two lawmakers asked FDA to explain its process for handling whistleblower complaints, and whether it prioritizes products that might be susceptible to dangerous supply shocks of products are recalled or production is shut down.

The lawmakers noted that the FDA’s inspection took more than a month to complete once it began on Jan. 31, and said it took the FDA until mid-May to recognize the formula supply shortage and take steps to expedite production.

The lawmakers asked FDA how long these inspections normally take, whether there is any process in place to speed up the process to avoid supply shortages, and why FDA did nothing between January and May 2022 to address the problem.

“The entire mishandling of this infant formula crisis is unacceptable and jeopardizes the health and well-being of millions of infants and those who rely on medically necessary metabolic formulas produced by Abbott Nutrition.”

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