Califf Details Unsanitary Formula Plant Conditions, Says FDA Should’ve Moved Quicker
“Frankly, the inspection results were shocking,” Dr. Robert Califf said of the Abbott Nutrition plant in Michigan while speaking to lawmakers about the infant formula shortage. A representative for Abbott also testified, giving a more optimistic timeline for reopening than the one outlined by the FDA.
The New York Times:
F.D.A. Chief Details ‘Shocking’ Conditions At Baby Formula Plant
The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel on Wednesday. He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., plant to lawmakers during a hearing, but he also acknowledged that his agency’s response was too slow in addressing problems at the plant. (Jewett and Bogel-Burroughs, 5/25)
Politico:
Abbott, FDA Offer Conflicting Timelines For Reopening Shuttered Infant Formula Plant
A senior official from the company at the center of the country’s infant formula shortages told lawmakers on Wednesday it can restart its now-shuttered plant as early as next week, disputing a timeline laid out just hours before by the head of the FDA. Christopher Calamari, who leads Abbott’s U.S. and Canada nutrition division, told lawmakers in sworn testimony Wednesday that the company hopes to reopen its now-shuttered plant in Sturgis, Mich. “the first week of June,” pending FDA approval. ... But FDA Commissioner Robert Califf testified earlier in the day that the plant is still “several weeks” away from reopening, and suggested it could be further delayed if Abbott doesn’t meet certain requirements. (Lee, 5/25)
Why didn't the FDA take action sooner? —
The Washington Post:
Whistleblower Report On Baby Formula Plant Didn't Reach Top FDA Food Safety Official For Months
When a whistleblower sent a 34-page report to the Food and Drug Administration in October alleging a host of unsanitary conditions at an Abbott infant formula factory, the top official in charge of food safety didn’t see it. In fact, Frank Yiannas, the FDA’s deputy commissioner for food policy and response, didn’t learn about the complaint until four months later, according to Yiannas and others knowledgeable about the case. (Kindy and Reiley, 5/25)
USA Today:
Baby Formula Shortage: FDA Chief Califf Admits Agency Was 'Too Slow'
Food and Drug Administration Commissioner Dr. Robert Califf admitted Wednesday that the agency has been "too slow" in responding to the baby formula shortage, a crisis that has hospitalized malnourished infants, emptied store shelves, and driven desperate parents from store to store and across state lines in search of food for their babies. Califf and other FDA officials were excoriated as they testified before a frustrated panel of lawmakers on the House Energy & Commerce Subcommittee on Oversight and Investigations. Democrats and Republicans were equally determined to get answers and prevent the shortage from happening again, they said. "Babies and children are suffering," Rep. Diana DeGette, D-Colo., said in her opening remarks as chair of the committee. (Woodall, 5/25)
Another shipment of formula arrives in the U.S. —
AP:
Jill Biden, Murthy Welcome 2nd Mass Delivery Of Baby Formula
Jill Biden and Surgeon General Vivek Murthy welcomed the delivery Wednesday of a second shipment of tens of thousands of pounds of baby formula that the Biden administration is importing from Europe to ease critical supply shortages in the U.S. The first lady and the nation’s doctor each sought to empathize with anxious parents nationwide who have been scrambling to find enough formula for their children. ... More deliveries are scheduled to arrive soon. The administration has cut the timeframe for deliveries to three days, down from up to four weeks, Murthy said.
Modern Healthcare:
Sick Kids, Anxious Parents Turn To Hospitals Amid Formula Shortage
The formula shortage is putting hospitals in a bind as desperate parents seek help and young children with special needs not getting adequate nutrition show up to pediatric wards and emergency departments. Although hospitals have formula on hand, they don't have enough to make up for the broken supply chain. "We definitely don't want to send a message 'Come to the hospital, we have an abundant supply of formula,' because unfortunately that's not the case," said Dr. James Franciosi, associate chief of the division of gastroenterology, hepatology and nutrition at Nemours Children's Hospital in Orlando, Florida. (Hartnett, 5/25)
The New York Times:
Can’t Find Your Baby Formula Due To The Shortage? Here’s What To Do
Below we’ve included a list of formulas that are available to order online (at this writing) and that the sellers say will ship within about a week or two. (We’ll update this list as stock and availability change.) Many infant formulas sold in the US are extremely similar, and experts say most babies can tolerate switching formulas well. In this article, we’ll tell you what to keep in mind about the current recall and formula safety, as well as some dos and don’ts for switching formula brands and types. (5/25)
