DeLauro Floor Remarks on Supplemental Funding to Address Infant Formula Shortage

2022-05-18 20:21

Statement

House Appropriations Committee Chair Rosa DeLauro (D-CT-03) today delivered the following remarks on the House Floor in support ofH.R. 7790, a supplemental appropriations bill to provide $28 million in emergency funding to give the U.S. Food and Drug Administration (FDA) the resources it needs to address the urgent infant formula shortage:

This supplemental funding legislation will work in tandem with President Biden's launch of Operation Fly Formula and invocation of the Defense Production Act to help quickly and safely address the infant formula shortage in this country and help prevent this from happening again.

I am shocked by the infant formula crisis. The shortage we are seeing today is in large part caused by some who chose not to prioritize the health and safety of our babies.

In September 2021, FDA inspectors conducted a routine inspection of the Abbott Nutrition facility in Sturgis, Michigan, where suspicions of wrongdoing were already present, as noted in a Bloomberg article, published on May 12, from a reporter who obtained the FDA report through a Freedom of Information Act request. On October 20, 2021, a whistleblower who worked at that Abbott facility submitted a report to the FDA unveiling a damning list of allegations of wrongdoing at the hands of Abbott. Recalls happen, but if the allegations are true, this company has lied, cut corners, and falsified records to cover up their misdoings at the sake of infant health. This is plain wrong.

But, this was in October. The FDA knew about what Abbott was doing in October, and yes, they dragged their feet. It was not until late December that the FDA interviewed the whistleblower. And then not until a month after that, in late January, was the plant inspected in person. Abbott then issued a recall in February. Four months later.

In March, I requested an HHS Office of Inspector General report to look into this tragedy, so that we can hold the bad actors accountable. And then I got hold of and submitted for the record a whistleblower report, with truly awful allegations against Abbott. Their wrongdoings included the falsification of records, testing seals on empty cans, and releasing untested infant formula, just to name a few. In essence, they put a product on the market, a contaminated product, which they knew was contaminated and we have lost at least two infants. Several were hospitalized.

Let's look back for a moment. Now, we are learning that in 2014 Abbott deliberately, and successfully, tried to weaken bacteria testing safety standards. At that time, the FDA issued a proposed rule that would have increased the regular safety inspections of infant formula manufacturing facilities, to prevent the contamination of infant formula. The very crisis that we have today.

The federal government has an important role to play in addressing this painful issue. As I said, at least two babies died, and four more were hospitalized - that we know of - because of corporate greed, consolidation, and a disgraceful lack of proper oversight by the FDA.

This is infant formula we are talking about. Parents trust that this formula will be safe and healthy for their newborn babies. It should be the most regulated and protected of any product. And here, we see Abbott putting production and profits before people. I introduced this bill this week because 43 percent of infant formula is out of stock nationwide. There is an immediate need to bring infant formula to the babies and families facing such dire necessity. 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 the food that they are giving their babies is safe.

Earlier this evening, President Biden announced that he would invoke the Defense Production Act to increase domestic production of infant formula, launching Operation Fly Formula to use federal planes to fly formula in from abroad. I have been calling for the swift importation of safe infant formula from FDA-approved facilities overseas since the beginning of this crisis. These steps will achieve this goal, and I applaud the Biden Administration for rising to this urgent challenge. Now that we are ramping up production and preparing to purchase formula from abroad, we must ensure that it is safe. I will repeat, this product needs to come from FDA approved facilities, so we make no mistake that they are adhering to a standard. The FDA needs the resources to do that.

The FDA plays a critical role in ensuring formula provides the full nutritional needs of infants and that it is manufactured in the safest way possible. We must ensure that a lack of funding is not a barrier to getting safe formula to parents and babies.

The bill before us does just that. It addresses this pressing need by providing $28 million in new funding for the FDA. These funds will be used to prevent fraudulent products from entering the marketplace, to acquire better data on the situation in the marketplace, and to fund the balance of FDA activities. To prevent shortages from happening again, funds will strengthen the workforce focused on formula issues and increase the FDA's inspection staff.

The FDA needs resources to be able to get this work done quickly, and safely, and that includes building their workforce. Right now, they only have nine people on staff inspecting and reviewing the submissions that could increase the number of FDA-approved facilities developing infant formula. It is not enough. Being able to have more staff doing this job will ensure FDA can increase the quantity of submissions being reviewed without risking the quality of the review process. We also would have the funds for a buttress, their inspection teams, so that we can get more FDA-approved facilities online.

I am proud that this bill meets this urgent need. People are looking for some relief, and I am proud that we are on the Floor tonight to ensure that families get this help as soon as possible. But we should not, and we will not, be made to choose between the health and the safety of our babies and the supply that keeps them fed. I reject this dangerous and false dichotomy.

Let me be clear: the funding in this bill seeks to address this shortage now, but we must simultaneously find solutions that prevent this contamination and the shortage from happening again. Our work here is not done. We will introduce legislation in the next several days to address the root causes of the issue, so that it does not happen again.

We all are heartbroken - both at the stories of the babies who died and their mourning families, and the millions of moms and dads today who are frantic and scrambling to find formula. Within their hearts, scared that the product they are giving their infant can potentially cause them grave harm. That is not who we are. Our babies are our most vulnerable, and we must work quickly and decisively to make safe formula available for every single baby in this country who needs it.

I urge my colleagues to support this absolutely critical piece of legislation, and I reserve the balance of my time.

117th Congress