Tags

, , , , , , , , , , ,

Below are some statements regarding yesterday’s hearing in the US House and a link to today’s hearing in the US Senate. Today’s hearing just started.

“FULL COMMITTEE HEARING Infant Formula Crisis: Addressing the Shortage and Getting Formula On Shelves” Date: Thursday, May 26, 2022 Time: 10:30 AM Location: 430 Dirksen Senate Office Building https://www.help.senate.gov/hearings/infant-formula-crisis-addressing-the-shortage-and-getting-formula-on-shelves

“Chairman Bishop Statement at Infant Formula Crisis Hearing
2022-05-25 14:11 Statement
Congressman Sanford Bishop (D-GA), Chair of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee, delivered the following remarks at the Subcommittee’s hearing on the infant formula crisis:

Following last week’s hearing with FDA Commissioner, Dr. Robert Califf, we are again looking at the infant formula recall, the nation-wide formula shortage, and the impact it is having on infants, kids, and families. 

Put together, our witnesses’ testimony will provide a comprehensive picture of how we got into this crisis, how it is affecting peoples’ day-to-day lives, and possible solutions as we look forward. 

With that, I am pleased to introduce and welcome our panel of witnesses: 
* Sarah Chamberlain – Executive Director, National PKU News; 
* Ginger Carney – Director of Clinical Nutrition at St. Jude Children’s Research Hospital;
* Michael Gay – Owner and Manager of Food Fresh in Claxton, Georgia representing the National Grocers Association; and 
* Brian Ronholm – Director of Food Policy at Consumer Reports. 

Thank you all so much for being here. 

FDA’s failure to expeditiously address the bacterial contamination at Abbott Nutrition’s formula processing plant raises serious structural questions.  We will hear about the organizational challenges at FDA and what steps we can take to make sure this does not happen again. Of course, part of the solution is more routine and robust inspections. To that end, last week, the House passed legislation to provide FDA resources to help ensure product safety. 

While FDA and Abbott have agreed to a plan to reopen the plant, and while planes filled with formula have started arriving from abroad, it will take weeks to fully alleviate the shortages. In that time, families will still face impossible decisions, such as rationing formula or deciding whether accessing formula may outweigh the potential risk of bacterial infection. 

Today, we will hear from a mother, Sarah Chamberlin, whose 8-year-old daughter relies on special formula for about 70 precent of her nutrition. It is a reminder that formula is not just for infants and that specialty formula is life-sustaining and can be needed lifelong as a medical treatment for certain conditions. Simply put – there are no alternatives. 

I am also glad we will hear from Michael Gay, representing the National Grocers Association. Grocers are very much on the frontlines. They are on the ground and can see a community’s needs in real time. I am very concerned about our rural communities that often have only one grocery store, leaving people with little choice but to travel significant distances for formula. 

I am also looking forward to hearing from our other witnesses – Ginger Carney who is the Director of Clinical Nutrition at St. Jude Children’s Research Hospital Carney and Brian Ronhom, the Director of Food Policy at Consumer Reports – to gain insight from their expert knowledge and decades of experience.

Both Abbott and FDA share in the blame for the situation we are in right now. I can only imagine the worry and stress families are under, and I am glad this committee will give a voice to those stories today. 

I again want to thank our witnesses for being here. We know how busy you all are. On behalf of the committee, we are grateful you have taken the time to speak with us today. 
Subcommittees: 
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (117th Congress)
117th Congress” https://appropriations.house.gov/news/statements/chairman-bishop-statement-at-infant-formula-crisis-hearing

Republican view:
“What we Learned in Today’s Oversight Hearing on Baby Formula
05.25.22
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. https://republicans-energycommerce.house.gov/news/leader-rodgers-parents-need-immediate-action-and-answers-on-the-baby-formula-crisis/

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: https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/FDA%20Testimony%20ECOI%20Infant%20Formula%205.25.2022%20final.pdf
*  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: https://youtu.be/w4lPBLFhiDg

“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: https://youtu.be/o7inX2YFxfs
“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.  https://youtu.be/ax2EUe8kNKo

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: https://youtu.be/gIIbgnJDIaY
“We’ve been communicating with HHS and having communications with the Secretary …. throughout the pandemic about baby formula.”  

Biden dismisses the idea that his administration should have acted sooner on baby formula shortage

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. 

The details: 

* 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. https://republicans-energycommerce.house.gov/news/what-we-learned-in-todays-oversight-hearing-on-baby-formula/

MEMBER MOMENTS 

“PRESS RELEASE
Leader Rodgers: Parents Need Immediate Action and Answers on the Baby Formula Crisis
05.25.22
Washington, D.C. — Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA) delivered the following remarks in today’s Oversight & Investigations Subcommittee hearing on the formula shortage crisis in the United States.

Excerpts and highlights from her prepared remarks:
[…]
THE CRISIS FACING PARENTS
“Now, regarding today’s hearing and the crisis point we’ve hit on baby formula shortages. Parents shouldn’t have to drive hours, paying record-high gas prices, visiting multiple stores to find some formula after midnight to finally feed their child for just two or three more days.

“That is the reality of this crisis in America today.

“It’s putting newborns and babies in the hospital.

“There are parents who are unsure if tomorrow they’ll be able to feed their baby.

“They need support and immediate meaningful action to increase supply.

“They also deserve answers.

“There are several reasons for this shortage, including failure by FDA and the Biden administration to act early enough to address supply shortages, and the Abbott shutdown that made this worse.”

THE FDA FAILED TO HAVE AN IMMEDIATE PLAN

“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.

“With Abbott being a major supplier and given the information at its disposal, the FDA should have known the plant closure would make the shortage even worse.”

FDA FAILED TO LEARN FROM ITS OWN HISTORY

“This is not the first time FDA has been confronted with looming supply crisis.

“In 2004, the U.S. flu vaccine supply was provided by only two manufacturers. One of the two manufacturers, a British company called Chiron shut down after FDA inspectors found safety problems.

“That meant just before flu season, half of the U.S. flu vaccine supply was gone.

“The Bush administration immediately took action to secure doses from other manufacturers and encourage foreign manufacturers to seek licensure from the FDA.

“When Abbott’s Sturgis plant closed in February, the Biden administration should have likewise acted with urgency to increase supply — on day one.

“Instead, the FDA didn’t act decisively until parents and media coverage forced them to move publicly.”

THE FDA’S FAILED RESPONSE

“FDA failed to react promptly to the warning signs it was getting about the Abbott Nutrition plant.

“In September 2021, FDA conducted an inspection and issued a 39-page report that found hazardous food safety practices and that product could have been contaminated.

“Around the same time the FDA received four complaints of Cronobacter infections in infants. Tragically, two of the babies died. All had reportedly consumed Abbott Nutrition product, though a link has yet to be established.

“In October 2021, the FDA received a 34-page complaint about the Sturgis plant from an Abbott ex-employee who alleged data falsification and release of untested product.

“There was a life and death crisis in front of the FDA, but they failed to see the severity of the situation.

“FDA reportedly did not interview the whistleblower until months later and did not reinspect the plant until January 2022.

“FDA did not even form an incident management group on infant formula until April 1, 2022 — more than 6 months after it found issues with the Abbott plan.”

WE MUST PASS THE BABIES NEED FORMULA NOW ACT

“This hearing is an opportunity to ensure parents are certain the FDA does not repeat mistakes that led to these shortages.

“I’m leading the Babies Need Formula Now Act to increase supply and restock empty shelves as soon as possible.

“This legislation also requires more oversight and accountability to ensure the Biden FDA is doing its job, acting quickly to maintain a healthy and safe supply of formula, and not wasting time or resources.

“We must solve the immediate issue and ensure parents can feed their babies now while also addressing the regulations and government policies that have made our formula supply chains so fragile.

“I look forward to hearing from Commissioner Califf on what the FDA did wrong and how we can ensure parents are never put in this situation again.”

SUBCOMMITTEES Oversight and Investigations (117th Congress) https://republicans-energycommerce.house.gov/news/leader-rodgers-parents-need-immediate-action-and-answers-on-the-baby-formula-crisis/