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NC Sen. Burr says that “complacency and deadlocked bureaucracy” at the FDA have led to baby formula shortages

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RALEIGH, NC (WNCN) — A North Carolina senator said Thursday that shortages of baby food across the country were caused in part by “complacency and entrenched bureaucracy” at the Biden administration’s U.S. Food and Drug Administration.

Sen. Richard Burr (R-NC), a senior member of the Senate Committee on Health, Education, Labor and Pensions, released a statement Thursday night about President Joe Biden’s administration and the FDA “causing the infant formula crisis.”

Baby formula supplies across the country have been severely curtailed for months following an Abbott Nutrition recall in February and a prolonged shutdown of the country’s largest baby formula factory.

This closure exacerbated ongoing supply chain disruptions at infant formula manufacturers, leaving fewer options on store shelves and increasingly concerned parents struggling to find food for their children.

FDA Commissioner Robert Califf faced the wrath of Congress Thursday for failing to answer questions about whether his agency should have intervened earlier at Abbott’s Michigan plant.

Califf is the first government official to testify before Congress on the issue, which has led many parents to seek infant formula and has become a talking point for Republicans.

Califf dodged questions about whether his agency should have stepped in earlier to address the crisis.

Burr released what he called a “timeline of failure,” noting that in February the Biden administration knew parents were struggling to find baby formula while production at the Michigan plant was shutting down.

Burr reported that the nationwide infant formula out-of-stock rate was 26 percent in mid-February.

“That should have set off alarm bells,” Burr said in an email. “It should have prompted the FDA to act quickly to resolve a legitimate public health issue — the possibility that isolated diseases could be linked to the formula made at Abbott’s facility — and safely resume production as soon as possible.” record.”

But Burr said the FDA has instead been “sluggish” in investigating and approving the plant’s reopening.

Regulators only said Monday they had reached an agreement that will allow Abbott Nutrition to restart the facility. The company must revise its safety protocols and procedures before resuming production.

After the FDA received the OK, Abbott said it will take eight to 10 weeks for new products to hit stores. The company has not set a timeline for resuming production.

“At every turn, the FDA’s culture of complacency and entrenched bureaucracy compounded this self-inflicted crisis,” Burr said in the statement.

By May 1, the national baby formula out-of-stock rate rose to 43 percent, according to data from Burr.

“I know parents across the country are concerned about finding enough formula to feed their babies,” Biden said in a video statement released by the White House on Wednesday. “As a parent and as a grandparent, I know how exhausting it is.”

He said some lawmakers believe the problem stems from a lack of funding, but pointed out that the FDA received $1.5 billion in COVID-19 relief funds and $1 billion for a food program.

“It’s not a funding problem; it’s a priority issue,” Burr said. “The government downplayed the shortage until it became a political burden on them.”

Lawmakers are also considering bolstering the Food and Drug Administration’s staffing levels with a $28 million emergency spending bill. That bill also passed the House of Representatives this week, but faces uncertain prospects in the Senate.

The Senate on Thursday passed a bill aimed at alleviating shortages of baby formula for families participating in a government assistance program that accounts for about half of all formula purchased in the United States.

The House of Representatives passed the law the day before, so it’s now up to Biden to sign the law.

Participants in a program called WIC receive coupons that can be redeemed for certain foods to supplement their diets. The coupons can usually only be used to purchase one brand of infant formula, encouraging the manufacturer to offer big discounts to secure a state’s business.

The bill allows the Department of Agriculture to waive certain requirements under mitigating circumstances to allow WIC participants to purchase any available brand.

Also on Thursday, the Biden administration said the Department of Defense is working to book airliners to fly about 246 pallets of Nestlé formula from Zurich, Switzerland, to Plainfield, Indiana.

“Baby food imports will serve as a bridge to this ramped-up production,” Biden wrote.

The shipments include the equivalent of up to 1.5 million 8-ounce bottles of three formulas – Alfamino Infant, Alfamino Junio ​​and Gerber Good Start Extensive HA, all hypoallergenic formulas for children with cow’s milk protein allergy. The White House said these are a priority because they serve a critical medical purpose and are in short supply.

https://www.cbs17.com/news/north-carolina-news/nc-sen-burr-says-complacency-and-entrenched-bureaucracy-at-fda-led-to-baby-formula-shortage/ NC Sen. Burr says that “complacency and deadlocked bureaucracy” at the FDA have led to baby formula shortages

DUSTIN JONES

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