House Appropriations Committee Chair Rosa DeLauro (D-CT-03) delivered the following remarks at the Agriculture, Rural Development, Food and Drug Adminstration, and Related Agencies Subcommittee's hearing on the infant formula crisis:
Thank you, Chairman Bishop and Acting Ranking Member Harris for holding what is an important hearing. And I want to particularly thank you our witnesses for testifying this on the infant formula crisis in our country.
We are all absolutely shocked by this crisis facing America’s babies and their moms and dads – a crisis of both safety and supply. At least two babies died, and several others were hospitalized, after consuming Abbott’s infant formula. And for the past several months, parents all over the country have been struggling to find safe formula to feed their babies.
On Monday, I held a roundtable in my district and heard heartbreaking stories of already vulnerable parents scrambling to feed their babies. They reiterated how formula that has been historically difficult to find is now nearly nonexistent on shelves. Moms and their advocates fear that babies may become undernourished and develop enduring health problems.
One 19-year-old mother told me that despite relying on formula to feed her three-month-old baby, she was denied WIC and was told she should just breastfeed. Like far too many others, she is unable to produce nourishing breast milk and relies on community support to feed her baby. And now, she is struggling to find any baby formula at all.
I also hear from grandmothers who were taking care of their grandchildren and having to take them to the emergency with vomiting and with diarrhea, linked directly to the formula that they were taking – Abbott formula.
Another was the mom of a baby who, after eating Abbott’s contaminated formula which was later on the recall list, was sick for eight days, in and out of the hospital, and told that her son merely had a virus. This formula stayed on shelves much longer than it should have. The stories I heard were absolutely unacceptable, and these same stories are happening in big cities, small towns, and rural communities all over our nation. Parents need more help.
As you know, in September 2021, FDA inspectors conducted a routine inspection of an Abbott Nutrition facility where suspicions of wrongdoing were already present. On October 20, someone working at that facility submitted a whistleblower report to the FDA unveiling a damning list of allegations, asserting that the company lied, cut corners, and falsified records to cover up their misdoings. Not until late December did the FDA interview the whistleblower. And then not until late January was the plant inspected in person. Abbott then issued the recall in February. Some four months later.
In March, I requested an HHS Office of Inspector General report to look into the tragedy. And then I got ahold of the whistleblower report and submitted it for the record to make it public. Last week, I introduced, and the House passed, a $28 million supplemental appropriations bill to give the FDA the resources it needs to address the current shortage. That is mostly personnel to be able to deal with inspecting facilities and also to review the infant formula applications that are coming in. They do not have the personnel. I have no problem faulting the FDA for what the have done, but we cannot compound the problem by not providing resources at this moment for much-needed inspection personnel and infant application submission reviewers in order to know that the products that are coming in are safe. And not wanting to move forward on that $28 million really says a lot about people and their care about what is going on in this space.
At a hearing last week, this subcommittee questioned FDA Commissioner Califf on the FDA’s incredibly slow response, which led to Abbott products staying on the shelves longer than they should have and potentially putting even more babies at risk.
In the long-term, the FDA must address its long-standing structural issues. I believe we must establish a Deputy Commissioner for food safety within the FDA, someone with extensive knowledge, background, and credentials in food safety.
This week, I will introduce the Keep Infant Formula Safe and on the Shelves Act which addresses the root causes of the crisis including product safety and supply infrastructure. And I am moving to deal with the issue of consolidation in the industry which only allows for four major suppliers. Thereby, if one is gone, we have this shortage that has been created.
Because unfortunately, none of this is new. We recently learned that in 2014, the formula industry deliberately and successfully tried to weaken bacteria testing safety standards. The FDA had proposed rules, a protocol, that year to increase the regular safety inspections of infant formula manufacturing facilities to prevent contamination – the specific contamination we are discussing today. The very crisis now facing our nation’s babies.
And while the FDA was slow to respond – and I am going to make a distinction between the FDA and the Biden Administration – because the Biden Administration moved quickly, as did USDA with dealing with waivers for WIC recipients to be able to purchase another product other than the Abbott product. The Administration, through Operation Fly Formula and the invocation of the Defense Production Act, has secured infant formula from FDA-regulated facilities to be flown in and imported quickly to meet this urgent need. I will follow up to make sure that they are FDA-approved facilities. I am concerned about FDA guidelines which say that we can entertain other facilities that do not meet the FDA standards.
The first batch of the formula arrived quickly. It arrived this week in Indianapolis. And more is coming. There’s a shipment that arrives at Dulles today. We are and the Administration is addressing the critical supply issue, while ensuring that the product being manufactured is safe and healthy for our babies.
In the wealthiest nation in the world, babies should not be at risk of going hungry. Parents should not have to play a guessing game and wonder if they are feeding their babies something that is safe. But unfortunately, that is where corporate greed, consolidation of formula production into just four major companies, and a lack of proper oversight have led us.
I hope that our witnesses can help us further understand the impact that this shortage has had on babies and their parents and what else we can do to prevent this from happening again.
I want to say a thank you again to the Chairman who really has moved – speaking about moving quickly – has moved very quickly on addressing this issue and calling hearings in order to address it. I also thank the Acting Ranking Member. I yield back.
Subcommittees:
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (117th Congress)
117th Congress
Original source can be found here.
