Today’s Oversight and Investigations Subcommittee hearing made clear the Biden administration’s failure to quickly act on the baby formula crisis. There should have been a plan before the Abbott plant closed.
Parents across the country deserve answers—and solutions—to the crisis they’re facing. E&C Republicans questioned the U.S. Food and Drug Administration (FDA) officials and formula suppliers on what more they should be doing to put baby formula back on the shelves and how to prevent this shortage from ever happening again.
Here are our key takeaways from the hearing:
The Biden administration and FDA wasted time and resources.
As Leader Rodgers said, “The Biden administration says it did not anticipate the formula shortage. But it should have. As part of its pandemic response, FDA had a data analytics tool to monitor the supply chains of various products including infant formula.
“The FDA’s food safety center was in contact with the infant formula industry to monitor ingredients and other components for production and to maintain a healthy and safe supply.
“A January Wall Street Journal article, a month before the Abbott plant closed, reported problems of “hard-to-find” formula.
“The FDA didn’t have to quote ‘read minds’ as the President dismissively suggested. They just had to read their own data and listen to parents.”
CLICK HERE to read her full opening remarks.
The FDA failed to plan with urgency for formula supply shortages.
The FDA should have been in rapid response mode immediately to increase the supply of infant formula in the U.S., especially when it knew about problems at Abbott’s Sturgis, Michigan facility that could impact the supply of infant formula. Where was the administration’s contingency plan to prevent the crisis we are seeing today?
Commissioner Califf confirmed to O&I Subcommittee Republican Leader Griffith that the FDA was “too slow.”
According to the timeline the FDA provided in official testimony:
- On September 20, 2021, the FDA began a routine surveillance inspection and found problems at the Abbott’s Sturgis facility.
- On September 20, 2021, the FDA received a consumer complaint report of Cronobacter illness in an infant.
- On September 21, 2021, the FDA informed Abbott of the Cronobacter complaint it received.
- On October 21, 2021, FDA received a complaint from a confidential informant electronically. It was reviewed by FDA staff. FDA claims it began planning for an inspection at Abbott’s Sturgis facility.
- On October 26, 2021, the FDA Detroit District Office received a hard copy of a complaint from a confidential informant. Due to an “isolated failure in FDA’s mailroom,” this complaint was not shared with FDA leadership.
- November 4, 2021, the FDA Office of Human and Animal Food Operations (OHAFO) began discussing the complaint with the FDA’s Office of Criminal Investigations.
- November 8, 2021, FDA OHAFO staff discuss confidential informant complaint with the investigator and National Expert Investigator who inspected the Sturgis facility in September 2021.
- December 1, 2021, the FDA received a consumer complaint of a Cronobacter death potentially associated with Abbott powdered infant formula.
- December 2, 2021, the FDA notifies Abbott of the second Cronobacter consumer complaint.
- December 7, 2021, the FDA requested an interview with the confidential informant, which was scheduled for December 22, 2021.
- December 30, 2021, FDA contacted Abbott to schedule an inspection for January 3, 2022. Abbott requested FDA delay the inspection due to an ongoing COVID-19 outbreak among its staff. FDA agreed to delay.
- January 11, 2022, the FDA received a third Cronobacter illness complaint.
- January 27, 2022, the FDA contacted Abbott to announce its intention to proceed with an inspection. Abbott informs FDA of a continued COVID-19 outbreak among its employees.
- January 31, 2022, FDA proceeded with an inspection of the Sturgis facility despite the COVID-19 outbreak given the fact pattern indicating a potential issue. FDA found “significant, fundamental sanitation, building, and equipment issues and takes multiple environmental samples.”
In short, it took FDA too long to inspect the Abbott facility.
When asked about why complaints and confidential informants weren’t taken seriously and acted upon fast enough, Commissioner Califf admitted:
“There was a failure to escalate, which was a system failure….It was a lack of coordination.”
The failure to share vital information about the looming crisis was a theme among FDA staff testimony. Frank Yiannas, M.P.H, the Deputy Commissioner of Food Policy and Response, is responsible for responding to the whistleblower reports. He didn’t hear about the report for months. He said:
“I’m not sure why the report wasn’t shared with me and how it didn’t get escalated.”
The White House knew about the supply shortages as early as February.
Rep. John Joyce (R-PA) asked Commissioner Califf when the FDA alerted the White House about the closure of the Abbott plant and who was alerted. The response? White House staff were alerted in early February.
Commissioner Califf also said that the FDA gave the White House memos that provided a “very elegant description of the issues and the concerns.”
In a response to Rep. Billy Long (R-MO), Commissioner Califf admitted that FDA has been communicating with HHS Secretary Becerra:
“We’ve been communicating with HHS and having communications with the Secretary …. throughout the pandemic about baby formula.”
The FDA informed the White House of the infant formula crisis in February. Meanwhile, President Biden is claiming that his administration couldn’t predict this crisis. When asked on May 13th, if the administration could have acted sooner, President Biden said, “If we’d been better mind readers, I guess we could have.”
Again, President Biden said this months after the FDA claimed to have informed the White House.
BABIES NEED FORMULA NOW ACT
As Leader Rodgers said today, parents “need support and immediate meaningful action to increase supply. They also deserve answers.”
That is why she is leading with House Republican Conference Chair Elise Stefanik (R-NY), Congresswoman Ashley Hinson (R-IA), and Congresswoman Stephanie Bice (R-OK) on legislation called the Babies Need Formula Now Act to increase the baby formula supply for parents as soon as possible.
In addition to addressing the immediate crisis parents and babies face, this legislation also requires more oversight and accountability over FDA to ensure the Biden administration is doing its job, acting quickly to maintain a healthy and safe supply of formula, and not wasting resources. To ensure parents have more choices in the future, it also reduces barriers to innovation for new brands and types of formula to enter the marketplace.
- Increasing Supply: The Babies Need More Formula Now Act makes sure the FDA is using every flexibility to import safe baby formula from abroad. It also temporarily lifts restrictions on infant formula to allow parents to order formula from countries that have similar safety standards as the United States.
- Requiring the FDA to be Transparent: Just giving the Biden administration more money will not address the immediate crisis or correct how it made these shortages worse. The Babies Need More Formula Now Act adds oversight and accountability to the FDA to make sure it is doing its job and acting quickly to maintain a healthy and safe supply of formula.
- Giving Parents More Choices: To prevent dangerous shortages from happening again, this solution also lifts FDA-imposed barriers that restrict new types and brands of formula from entering the market. It ensures more competition so more formula will reach the shelves and parents have more options to keep their babies fed.
- Enhancing Accountability for Recalls: When there is a recall for labeling unrelated to the quality of the product, the FDA needs to consider the impact to the supply of formula before recommending or requiring a recall. The Babies Need More Formula Now Act requires the FDA to notify to Congress of recalls and provide a plan to address any supply issues that may result. It requires coordination between the FDA and the manufacturer of the recalled formula to resolve any issues as soon as possible.