HEALTH CARE BRIEFING: FDA Saw Baby Formula Plant Risks Last Year

By Brandon Lee

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U.S. inspectors spotted the potential for baby formula made at an Abbott Laboratories plant to become contaminated months before a recall that exacerbated a nationwide shortage, a government document shows.

A Food and Drug Administration report obtained by Bloomberg News through a Freedom of Information Act request showed that during a routine visit to Abbott’s Sturgis, Mich., manufacturing facility in September, inspectors determined that employees might have transferred contaminants including deadly cronobacter from surfaces to baby formula. And in one instance, the report said, records showed Abbott detected cronobacter in a finished batch of formula that may have been tainted by a worker who touched a contaminated surface without changing gloves. That batch wasn’t distributed.

Formula shortages have exploded since Abbott recalled Similac and other top-selling brands in February, alarming parents and stoking lawmakers’ concerns. Federal officials have investigated the cases of four babies who fell ill—including two who died—from cronobacter after ingesting formula made at Abbott’s Sturgis plant.

Abbott maintains its formula isn’t to blame for sickening those children. “There is no evidence to link our formulas to these infant illnesses,” the company said in a statement to Bloomberg, without remarking on the detailed inspection report. Abbott previously has said it found cronobacter in formula that it didn’t distribute in 2019 and 2020, and the FDA has said its inspectors again found the pathogen in the plant this year.

The matter is getting increasing attention in Washington, where the White House has tried to reassure parents that supplies will be replenished, and President Joe Biden met Thursday with manufacturers and retailers to find ways to increase supplies. Abbott said this week that it could restart production in the coming weeks and get formula back on shelves within two months, pending clearance from the FDA. Read more from Anna Edney.

Biden on Defense Amid Shortages: Meanwhile, the White House raced Thursday to show it’s trying to ease formula shortages, as Republicans showered criticism on Biden for a crisis that has left frantic parents scouring store shelves to feed their children. The White House is asking more states to relax rules on sizes and types of formulas eligible for government benefits, permitting parents to use subsidies for whatever products are in stock.

The White House also called on the Federal Trade Commission and state attorneys general to crack down on price gouging, and said that the FDA will in the coming days announce steps that should speed imports of baby formula from Mexico, Chile, Ireland and the Netherlands. “President Biden has directed the administration to work urgently to ensure that infant formula is safe and available for families across the country,” White House Press Secretary Jen Psaki told reporters in a briefing.

Congressional Republicans assailed the president and the FDA, saying the agency has been slow to respond to the shortage and stingy with information. Senate Republican leader Mitch McConnell (R-Ky.) on Thursday said the FDA “has been asleep at the switch in terms of getting production back online.” He called the situation “outrageous,” and added that senators of both parties have asked the White House and the FDA for answers “and gotten very few.” Justin Sink and Anna Edney have more.

Also on Lawmakers’ Radars

Sanders Revives His Medicare for All Bill: Senate Banking Chairman Bernie Sanders (I-Vt.) revived his Medicare for All legislation, arguing that ending most private health insurance and shifting to a single-payer system could cure much of what ails US health care. Rising health services and medicine costs have put many Americans into debt, and broad public health insurance would solve many problems, Sanders said at a committee hearing on Thursday. “This dysfunctional health care system cannot be rationally defended,” he said. Read more from Alex Ruoff.

Meatpackers Ignored Covid Spread, Report Says: The nation’s biggest meatpackers ignored warnings that the coronavirus was spreading through their plants, hyped claims of impending shortages and helped draft a Trump administration order to keep the facilities running during the early days of the pandemic, a congressional investigation by the House panel examining the nation’s pandemic response found. Chair James Clyburn (D-S.C.) said “shameful conduct” of meatpacking executives “prioritized industry production” over the health of workers. Mike Dorning has more.

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What Else to Know Today

Nursing Home Inspection Woes Spur Money Influx: Biden’s call to boost funding for nursing home inspections should improve state and federal oversight, but the extra money alone isn’t likely to fix longstanding problems that have undermined the process for years, resident advocates say. The Centers for Medicare and Medicaid Services is responsible for inspecting and certifying that most of the country’s 15,000-plus nursing homes meet federal guidelines required to participate in both programs. And the Covid deaths of 200,000 nursing home residents and staff have only magnified the urgency of that mission.

But the annual appropriation for inspection and certification activities at nursing homes, home health agencies, and hospices has remained at just over $397 million since the 2014 fiscal year, the agency reports. Biden‘s budget calls for boosting that amount by nearly $97 million to $494.3 million in fiscal 2023. Read more from Tony Pugh.

US, EU Grieve Millions of Covid Dead in Vaccine Summit: Biden and fellow world leaders called for a new push to quell Covid’s spread abroad, as the US and Europe marked grim milestones and American lawmakers balk at fresh funding. The White House opened its second summit aimed at bringing the virus to heel Thursday, where leaders acknowledged Covid deaths surpassing 1 million in the US and 2 million in the EU. Biden renewed a call for Congress to approve a new round of funding for vaccines, tests and treatments for domestic use and for the global vaccination campaign, Josh Wingrove reports.

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To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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