May 13, 2022
Exclusive: Rep. Stefanik Blasts Biden Administration for Formula Shortage, Says FDA has Known About Threat Since February
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The Biden Administration has been aware of the threat of a national baby formula shortage for “months,” House Republican Conference Chair Elise Stefanik (R-NY) told Breitbart News – on the same day President Biden claimed only “mind readers” could have anticipated the crisis.
“We moved as quickly as the problem became apparent to us,” he continued, adding, “we have to move with caution as well as speed because we got to make sure what we’re getting is, in fact, first-rate product – that’s why the [Food and Drug Administration] has to go through the process.”
The White House also announced Friday that invoking the Defense Production Act to produce baby formula amid the shortage is “on the table.”
But Rep. Stefanik told Breitbart News in a wide-ranging interview on Friday that Biden has been “asleep at the switch,” and that the FDA has known about a pending baby formula shortage for over three months – at least since she reached out to warn them of it in February.
“They’ve known this has been an issue for months. I sounded the alarm and reached out to the FDA in February of this year, after the recall of the Sturgis, Michigan, [Abott Nutrition] manufacturing facility, and we got no substantive response from the FDA. There was absolutely no plan from this administration about how to address that supply chain issue, which has now created even more of a crisis,” Stefanik said.
She compared this administration’s response to the baby formula crisis to the Trump Administration’s Operation Warp Speed – where the FDA, in collaboration with private companies, produced a COVID vaccine on a fast-tracked timeline by cutting regulations and curtailing the approval process.
“If you compare the failure of Joe Biden to the success of President Trump, in cutting through the red tape of the FDA when it came to Operation warp speed – Joe Biden’s been asleep at the switch.”
House Republicans – including Rep. Stefanik – sent a letter this week to the President demanding specific answers as to how the administration will work to increase the supply of formula. Stefanik told Breitbart News that she is also working on legislation to require the FDA to have a faster timeline in addressing supply chain issues.
“House Republicans have introduced the Formula Act, and I’m also working on legislation that requires the FDA, when there is a recall or issue at a manufacturing facility, to have a much shorter timeline in terms of figuring out an alternative supply chain or getting it back up and running,” Stefanik said.
Stefanik went on to blast the Biden Administration amid reports that baby formula is being sent to illegal immigrants who have entered the country at the southern border, while American citizens find empty shelves at their local grocery stores.
“The sending of baby formula paid for by taxpayers to the southern border for illegal immigrants, while American families, American babies, go without, that is unacceptable as well,” Stefanik said.
Stefanik called the situation “harrowing,” as she herself has found empty shelves when looking to buy formula for her young son, in her district in upstate New York.
“I can tell you as a new mom, there’s nothing more harrowing than being concerned about whether you’re going to be able to feed your baby,” Stefanik told Breitbart News.
News Source: breitbart.com
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President Biden Invokes Defense Production Act For Baby Formula Shortage
PHILADELPHIA (AP) — President Joe Biden on Wednesday invoked the Defense Production Act to speed production of infant formula and authorized flights to import supply from overseas, as he faces mounting political pressure over a domestic shortage caused by the safety-related closure of the country’s largest formula manufacturing plant.
The Defense Production Act order requires suppliers of formula manufacturers to fulfill orders from those companies before other customers, in an effort to eliminate production bottlenecks. Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S., in what the White House is calling “Operation Fly Formula.”
I’m taking two new steps to increase baby formula supply:
– Invoking the Defense Production Act to increase domestic production
– Launching Operation Fly Formula to use federal planes to fly formula in from abroad
We're making sure safe formula gets to all who need it. pic.twitter.com/lnkxsaCY6T
— President Biden (@POTUS) May 18, 2022READ MORE: New Jersey Veterinarians Discovering Unintended Consequence From Legalized Recreational Marijuana
Supplies of baby formula across the country have been severely curtailed in recent weeks after a February recall by Abbott Nutrition exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves and increasingly anxious parents struggling to find nutrition for their children.
The announcement comes two days after the Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.
In a letter Wednesday to the Department of Health and Human Services and the Department of Agriculture, Biden directed the agencies to work with the Pentagon to identify overseas supply of formula that meets U.S. standards over the next week, so that chartered Defense Department flights can swiftly fly it to the U.S.
“Imports of baby formula will serve as a bridge to this ramped-up production,” Biden wrote.
Baby Formula Shortage Resources Guide
Regulators said Monday that they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan, plant, the nation’s largest formula plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.
After getting the FDA’s OK, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company didn’t set a timeline to restart manufacturing.
The White House actions come as the Democratic-led House is expected to approve two bills Wednesday addressing the baby formula shortage as lawmakers look to show progress on what has become a frightening development for many families.
One bill expected to have wide bipartisan support would give the secretary of the Department of Agriculture the ability to issue a narrow set of waivers in the event of a supply disruption. The goal is to give participants in an assistance program commonly known as WIC the ability to use vouchers to purchase formula from any producer rather than be limited to one brand that may be unavailable. The WIC program accounts for about half of infant formula sales in the U.S.READ MORE: Republican Nomination For Pennsylvania U.S. Senate Race Uncertain As Thousands Of Mail-In Votes Still Being Counted
The other measure, a $28 million emergency spending bill to boost resources at the Food and Drug Administration, is expected to have less bipartisan support and it’s unclear whether the Senate will take it up.
“This is throwing more FDA staff at a problem that needs more production, not more FDA staff,” said Rep. Bill Huizenga, R-Mich.
Rep. Rosa DeLauro, the Democratic chair of the House Appropriations Committee, said the money would increase FDA staffing to boost inspections of domestic and international suppliers, prevent fraudulent products from getting onto store shelves and acquire better data on the marketplace.
Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from its plant. All four infants were hospitalized with a rare type of bacterial infection and two died.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside safety expert to restart and maintain production.
Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from two babies by federal investigators.
But FDA officials pushed back on that reasoning Monday on a call with reporters — their first time publicly addressing the company’s argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.
“Right from the get-go we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two,” FDA’s food director Susan Mayne said.
Fixing the violations uncovered at Abbott’s plant will take time, according to former FDA officials. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.
As part of the FDA’s new import policy, regulators said companies would need to provide documentation of their factory’s inspections.MORE NEWS: Where's Wilder? York County Woman's Stolen Car Found In Philadelphia But Dog Nowhere To Be Found
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