HEALTH BRIEFING: The FDA saw risks to baby food crops last year
US inspectors discovered the potential for baby formula made at an Abbott Laboratories plant months before a recall that exacerbated a nationwide shortage, a government document shows.
A report by the Food and Drug Administration, provided to Bloomberg News in response to a Freedom of Information Act request, showed that during a routine visit to Abbott’s Sturgis, Michigan manufacturing facility in September, inspectors found employees may have found contaminants, including deadly cronobacter, transmitted to babies from surfaces Formula. And in one case, the report said, records showed Abbott spotted Cronobacter in a finished batch of formulas that may have been spoiled by a worker who touched a contaminated surface without changing gloves. This batch was not distributed.
Formula shortages have exploded since Abbott recalled Similac and other top-selling brands in February, alarming parents and fueling lawmakers’ concerns. Federal officials have been investigating the cases of four babies who contracted Cronobacter – including two who died – after taking formula made at Abbott’s Sturgis plant.
Abbott claims his formula is not responsible for these children getting sick. “There is no evidence that our formulas are associated with these childhood illnesses,” the company said in a statement to Bloomberg, without commenting on the detailed inspection report. Abbott has previously said it found Cronobacter in the formula, which it didn’t distribute in 2019 and 2020, and the FDA has said its inspectors found the pathogen in the plant again this year.
The matter is receiving increasing attention in Washington, where the White House has tried to reassure parents that supplies are being replenished and President Joe Biden met with manufacturers and retailers on Thursday to explore ways to increase supplies . Abbott said this week that it could resume production in the coming weeks and get the formula back on shelves within two months, subject to FDA clearance. Read more from Anna Edney.
Biden on defense amid tight spots: Meanwhile, the White House raced Thursday to show it is trying to alleviate a lack of formulas as Republicans slammed Biden over a crisis that has left parents frantically combing store shelves to find theirs to feed children. The White House is asking more states to relax rules on sizes and types of formulas eligible for state benefits and to allow parents to use subsidies on any products that are in stock.
The White House also called on the Federal Trade Commission and attorneys general to crack down on price gouging and said the FDA would announce steps in the coming days that should speed up imports of baby formula from Mexico, Chile, Ireland and the Netherlands. “President Biden has directed the administration to urgently work to ensure infant formula is safe and available to families across the country,” White House press secretary Jen Psaki told reporters in a briefing.
Republicans in Congress attacked the President and the FDA, saying the agency was slow to respond to the shortage and stingy with information. Leader of the Republicans in the Senate Mitch McConnell (R-Ky.) said Thursday the FDA was “sleeping at the counter to get production back online.” He called the situation “outrageous,” adding that senators from both parties have asked the White House and FDA for answers, “and very few have received.” Justin Sink and Anna Edney have more.
Also on the radar of the legislature
Sanders revives its Medicare for All bill: Senate Banking Chairman Bernie Sanders (I-Vt.) revived its Medicare for All legislation, arguing that ending most private health insurance and moving to a single-payer system could cure much of what plagues US healthcare. Rising health care and drug costs have put many Americans in debt, and broad public health insurance would solve many problems, Sanders said at a committee hearing Thursday. “This dysfunctional healthcare system cannot be rationally defended,” he said. Read more from Alex Ruoff.
Meatpackers ignored spread of Covid, report says: The country’s biggest meatpackers ignored warnings that the coronavirus was spreading at their plants, exaggerated claims of impending shortages, and helped draft a Trump administration order to keep plants running in the early days of the pandemic, an investigation of Congress by the House panel examining the country’s pandemic response. chair James Clyburn (DS.C.) said the “shameful behavior” of meatpacking executives had “put industrial production ahead of workers’ health.” Mike Dorning has more.
Ads Mentioning Abortion Jump After Leak: Mention of abortion in political television advertisements has skyrocketed since a draft US Supreme Court ruling in Roe v. Wade was released. According to a report by the Wesleyan Media Project, which tracks campaign spending, 22% of pro-Democracy ads and 24.5% of pro-Republican ads running in US home races since the May 2 leak mentioned abortion. Previously, 6.2% of Democratic and 13.5% of Republican ads mentioned the problem. The bump has also appeared in governor’s ads, the report showed. Read more from Shruti Date Singh.
What else should you know today?
Nursing home inspection ensures cash inflow: Biden’s call to increase funding for nursing home inspections should improve state and federal oversight, but the extra money alone is unlikely to fix long-standing problems that have eroded the process for years, residents say. The Centers for Medicare and Medicaid Services are responsible for testing and certifying that most of the nation’s more than 15,000 nursing homes meet the federal guidelines required to participate in both programs. And the Covid deaths of 200,000 care home residents and staff have only added to the urgency of this mission.
However, annual funding for inspection and certification activities in nursing homes, community health agencies, and hospices has remained at just over $397 million since fiscal 2014, the agency reports. Biden’s budget calls for increasing that amount by nearly $97 million to $494.3 million in fiscal 2023. Read more from Tony Pugh.
USA and EU mourn millions of Covid deaths at vaccination summit: Biden and other leaders have called for a fresh push to stem the spread of Covid abroad as the US and Europe mark somber milestones and American lawmakers balk at fresh funding. The White House on Thursday opened its second summit aimed at getting a grip on the virus, where leaders confirmed Covid deaths have surpassed 1 million in the US and 2 million in the EU. Biden again asked Congress to approve a new round of funding for vaccines, tests and treatments for home use and for the global immunization campaign, reports Josh Wingrove.
Watchdog says a quarter of Medicare patients experience harm: A federal regulator wants the Department of Health and Human Services to implement seven recommendations after finding that 25% of Medicare beneficiaries suffered patient harm during hospitalizations in 2018 — even though 43% of the incidents were preventable and related to poor care were brought. According to a study by the Health and Human Services Office of Inspector General, 12 percent of patients experienced adverse events that resulted in either prolonged hospital stays, permanent damage, life-saving interventions, or even death. Read more from Tony Pugh.
Medicaid regains authority to deduct from health insurance: State Medicaid programs will regain the authority they lost in the Trump era to withhold union dues and benefit deductions from home health worker payments. Thursday’s final disqualification is the latest step in a back-and-forth battle between Democratic and Republican presidents over how Medicaid programs should interact with home health workers and their unions. It is about the interpretation of Medicaid statutory language, which precludes payments to anyone other than the person or entity that provided a covered service. Read more from Christopher Brown.
Visa Ban Procedure for Mexican Plasma Vendors Proceeds: Human blood plasma collection companies operating near the U.S.-Mexico border could file a lawsuit challenging a 2021 Customs and Border Protection policy that barred Mexican donors, the DC Circuit said Tuesday. A lower court wrongly dismissed the case on the grounds that the companies are not entitled to reputation because they are not within the “zone of interest” defined by the B-1 visa visitor classification under the Immigration and Nationality Act, the US Circuit Court of Appeals, protected is said for the DC circuit. Read more from Mary Anne Pazanowski.
To contact the reporter on this story: Brandon Lee in Washington [email protected]