Breaking down the Biden administration’s response to the baby formula shortage



CNN
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The infant formula shortage has affected millions of families across the country and left the Biden administration scrambling to figure out what went wrong after clear miscommunication and mishandling by the US Food and Drug Administration.

President Joe Biden conceded Wednesday he didn’t understand how big of an effect the shutdown of an Abbott baby formula plant in Michigan and subsequent recalls would have on the baby formula supply until April – but the FDA became aware of the issue in the fall of 2021, according to a CNN analysis and congressional testimony.

The White House has previously said it had been working on addressing the shortages since February.

Here’s a look into the timeline of the baby formula shortage, when the FDA first learned of the issue and when the White House became involved.

The FDA learns of an infant who contracts a Cronobacter infection after they consumed baby formula produced at Abbott Nutrition’s Sturgis, Michigan, facility. According to the FDA, the department “immediately reported this case to Abbott Nutrition and immediately followed up on the complaint, including testing formula associated with this case complaint. No Cronobacter was recovered from the product after FDA testing.”

The date on the whistleblower report that details allegations of negligent cleaning practices and efforts from officials at Abbott to keep the FDA from learning about safety problems at the Sturgis plant.

According to House Appropriations Chairwoman Rosa DeLauro, a Connecticut Democrat, this is the day the whistleblower report was submitted to the FDA.

This is the day the FDA received the whistleblower complaint from a confidential informant electronically, according to congressional testimony. They said the “(c)omplaint is reviewed by multiple FDA staff. FDA acknowledges receipt. FDA begins planning for an inspection at Abbott Nutrition’s Sturgis facility.”

According to the FDA, the FDA Detroit District Office receives a hard copy of the whistleblower complaint. The FDA says that leadership did not receive direct copies of the complaint due to an isolated failure in the FDA’s mailroom, likely due to Covid-19-related staffing issues.

CNN reports that Walgreens, which operates more than 9,000 locations across the United States, said demand for infant formula is increasing nationwide while its suppliers are struggling to quickly meet orders.

“(This) may cause temporary and isolated shortages,” Emily Hartwig-Mekstan, spokesperson for Walgreens, said at the time.

The FDA learns of the second case involving an infant with Cronobacter infection. The FDA says in its congressional testimony the department “again collected intact samples of powdered formula,” and no Cronobacter was recovered.

The FDA begins planning for an inspection at Abbott’s Sturgis facility with an anticipated date in early January 2022. The FDA notified Abbott of the planned inspection on December 30. According to the FDA, Abbott Nutrition responded by telling the FDA of approximately a dozen Covid-19-positive employees in its facility. The FDA says it delayed its inspection until January 31.

According to the FDA, the agency requests to interview the confidential informant who submitted the whistleblower report, “but due to scheduling limitations associated with the informant, the interview was not scheduled until December 22, 2021.”

According to the FDA, the agency interviews the whistleblower. The FDA says “this information informs the inspection that occurs in January 2022.”

The FDA says it learns of a third infant who contracted Cronobacter illness on January 11. Remember, the FDA has not yet inspected the Sturgis facility because of Covid-19 cases. Again, the FDA tested the Abbott product associated with this illness, found no Cronobacter and notified Abbott Nutrition, it said.

FDA says it finally begins inspection of Abbott Sturgis facility after delays.

Dr. Janet Woodcock, the then-acting commissioner of the FDA, received the whistleblower report via email, according to congressional testimony.

The Senate votes to confirm Dr. Robert Califf as the next commissioner of the FDA, despite opposition from some Democrats regarding his ties to the pharmaceutical industry.

The FDA learns of a fourth case of Cronobacter infection in an infant on February 17, the same date on which Abbott Nutrition initiated a voluntary recall and FDA issued a consumer advisory.

The FDA also requests that FMI, the Food Industry Association, “asks retailers to limit sales to no more than five cans of baby formula per shopper.”

US Department of Agriculture’s Food and Nutrition Service learns of the formula recall and immediately begins working to both notify state agencies administering the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and provide the flexibilities needed to ensure families can get the formula they need.

Russia invades Ukraine. According to the FDA, “This leads to additional uncertainty in the infant formula supply chain as Ukraine is a major exporter of sunflower oil, an ingredient used in many infant formulas.” This is also the next shortage the FDA is worried about.

The FDA’s Sturgis plant inspection and related sampling activities finally conclude.

The FDA creates its intra-agency working group on baby formula, according to congressional testimony.

Abbott says it responded to the FDA’s inspection findings, according to congressional testimony.

Then-White House press secretary Jen Psaki is asked for the first time about concerns about a formula shortage. She says the FDA is “working around the clock to address any possible shortage,” saying the agency is working with manufacturers to increase production, exercising flexibility and streamlining the import entry review process.

Abbott announces the company could restart its Sturgis plant within two weeks with FDA approval, which would put products onto shelves six to eight weeks later.

Biden holds virtual meetings with the leadership of retailers Target and Walmart, as well as formula manufacturers Reckitt and Gerber.

Biden addresses the shortage for the first time during an event on American Rescue Plan funding.

“I’ll answer the baby formula question because, all of a sudden, it’s on the front page of every newspaper,” Biden told a reporter, highlighting efforts to increase flexibilities in the WIC program and importation of formula from abroad. He said he spoke by phone with Walmart and other major distributors. “I think we’re going to be, in a matter of weeks or less, getting significantly more formula on shelves,” he said.

Pressed on whether his administration should have anticipated the shortage sooner, he said, “If we’d been better mind readers, I guess we could have, but we moved as quickly as the problem became apparent to us. And 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.”

The Department of Health and Human Services launches hhs.gov/formula, a website to provide information and resources to parents on formula. CNN’s MJ Lee tested the resources out over the weekend, an exercise that resulted in apologetic customer service representatives, one hold time that lasted well over an hour, and serious challenges in finding baby formula through some of the main suggestions listed on the new HHS website.

FDA commissioner Califf tells CNN’s “New Day” the administration is “doing everything we can” to resolve the shortage. Califf pointed to efforts to work with manufacturers to increase production, work on supply chain, and work closely with Abbott to get its shuttered plant open as soon as possible. He suggested the FDA would make it possible for formula intended for other countries to become available in the US in a set of announcements expected “by the end of the day today.”

Biden invokes the Defense Production Act to speed production of infant formula. He also issues a direct-to-camera video on White House social media channels with updates on overall efforts to boost supply.

The White House launches whitehouse.gov/formula, a new website that “will track and show the American people the actions we are taking to get more safe infant formula to shelves,” per a White House official.

Breaking down the Biden administration’s response to the baby formula shortage

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