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FDA baby formula review spares specific blame amid ongoing shortages


Some parents and advocates have been eagerly awaiting the review to shed specific light on FDA failures in order to hold them accountable, but Califf said in an interview shortly after the report’s release that the review was intended to “identify issues” that the FDA needs to improve in the future. Califf noted that the agency provided a detailed timeline for its response and that an independent review by the FDA’s largest food division is underway.

“We’re not going to spend a lot of time going back,” Califf said. “We’re going to spend our time considering what happened next and moving forward.”

Califf said accountability around the crisis is “managed through staff process” and noted the ongoing review of the food program. The FDA chief said he thinks the report “gives us a pretty clear roadmap for infant formula issues and provides a good bridge to the overall assessment of the feeding program.”

The Abbott plant closure turned into a political storm for President Joe Biden in May. After months of delays, federal inspectors finally found strains of a bacteria known as cronobacter sakazakii at the Abbott plant. Reports of multiple deaths of babies who drank formula from the plant added to the urgency of addressing the situation, but the FDA was unable to match the specific strains found in the plant to the one of the reported deaths. The plant closure has caused major disruptions in the supply of infant formula in the United States, causing panic among parents and adults who depend on infant formula.

The FDA’s food division has a history of internal delays and operational failures, a POLITICO investigation found. Rather than assigning specific blame to one entity, the report identifies general failings and provides recommendations for the FDA to address similar issues in the future. Solomon in part recommended that the FDA adopt better information technology systems to better track and share data, more staff and training, and updated emergency response systems to deal with real-time food security crises – which has long been a criticism of the agency.

Califf in the interview said the Biden administration is working diligently to restock infant formula supplies across the country, but noted data the administration is currently tracking indicating stock levels of 80%. He said FDA officials were conducting daily calls and meetings to shore up inventory and resolve ongoing supply chain issues with private companies.

Califf declined to provide a specific timeline for when American families can expect infant formula supplies to stabilize and noted that the most intense supply shortages were in specialty formulas for children suffering. allergies and specific metabolic diseases, which the FDA has tackled. But, in general, he said “things are looking really good now and I think it’s going to get better and better for families.”

Even though the worst of the supply crisis has eased, parents in many parts of the United States, including large swaths of Texas, are still struggling to find adequate supplies.

“It’s not over for us,” one Dallas mother told POLITICO, noting that she continues to see largely empty formula shelves at stores in her neighborhood.

FDA Commissioner Robert Califf admitted to lawmakers earlier this spring that the agency’s response to the crisis had been marred in part by a series of internal failures over the months of responding. The agency received warnings as early as fall 2021 about the Abbott Nutrition plant at the center of the current shortages, including a 34-page whistleblower report that was sent directly to FDA officials in October 2021. FDA did not interview the whistleblower until December. and did not reinspect the factory until late January, as the agency delayed many in-person inspections during the height of the Covid-19 pandemic.

Following Abbott’s closure and recall of some products made at its Sturgis, Michigan plant in mid-February, the plant quietly resumed operations on July 1, as POLITICO reported. for the first time. Abbott said the facility, which had resumed production for a brief period, was knocked offline again in June by severe storms and flooding.

Califf, who was confirmed by the Senate to his current position days before the recall, declined in the interview to say when someone from the FDA specifically briefed White House officials on potential issues with the plant. Abbott for infant formula supplies nationwide. Califf pointed to the timeline for the FDA’s response, which does not specifically say when FDA officials notified the White House. The timeline shows that the FDA notified the USDA, which administers the WIC program, just days before the recall in early February.

Before Califf testified before lawmakers this spring, the FDA said senior officials had not received the whistleblower’s report due to pandemic “mailroom issues.” Bipartisan lawmakers largely rejected that initial administration response.

The war in Ukraine overshadowed the White House’s early response to infant formula in February as administration officials failed to fully grasp the scale of shortages to come due to incomplete data and a federal response. already hindered. The administration has since pushed for better data on the nation’s infant formula supplies, and the FDA is pushing Congress to give the federal government the power to demand such data from private companies.

Since the spring, the Biden administration has taken a series of actions to promote competition in the hyper-consolidated U.S. infant formula industry and replenish supplies, including dozens of military flights to ship formula from the foreign.

Solomon added that the FDA’s review and findings focus on areas “within the agency’s purview.” Other factors, he added, include the consolidation of the hyper-consolidated U.S. infant formula market and specific supply chain issues “need to be addressed by other external stakeholders.”

Both Califf and Solomon said the review made it clear that the FDA needs to devote more time and resources to learning more about cronobacter, a prevalent bacteria that has proven extremely difficult for the federal government to properly track and to match specific cases.

The Biden administration also recently extended federal flexibilities through the end of the year to help low-income parents and infants access a wider variety of formula through the federal WIC nutrition program. Half of all infant formula in the country is purchased through the program. But the federal program’s restrictions and Abbott’s dominance over it have proven to be a major problem for low-income Americans during the pricing crisis – as the WIC program awards exclusive contracts nationwide. State primarily to two infant formula companies that dominate the US baby formulas market.

Texas, where the state’s WIC program is provided exclusively by Abbott, plans to move away from Abbott amid the chaos the shortages have unleashed on state WIC programs. State officials said Texas will begin a new contract Oct. 1 with Mead Johnson, the nation’s other major infant formula maker, when the current Abbott contract expires.

“I feel like we’re still in the middle,” a Texas healthcare provider said of the formula crisis. State officials have not yet clarified whether Texas will continue to honor WIC flexibilities for Mead Johnson products in the future if supplies are out of stock.

The Abbott Nutrition factory at the center of the shortages is still not operating at full capacity, but has started producing its widely used regular Similac formula in recent weeks. Abbott also extended until October 30 the waivers it currently pays to help families purchase other brands of available formula if Abbott products are out of stock.


POLITICO

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