House Appropriations Committee Chair Rosa DeLauro (D-CT-03) today delivered the following remarks to the House Rules Committee in support of an appropriate rule for the House to consider, 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.
Thank you very much Mr. Chairman and thank you Ranking Member Cole and Members of the Rules Committee for the opportunity to appear before you today to discuss supplemental funding legislation to address the infant formula shortage in the country.
The bill immediately addresses this shortage, and it will help prevent this from potentially happening again. But this shortage is caused in large part by corporate greed and due to a disgraceful lack of oversight, is now causing parents and caregivers to struggle to feed their kids. The images of empty shelves and desperate parents are heartbreaking. But we must act, and we must act now.
The FDA plays a critical role in ensuring that formula provides the full nutritional needs of infants and that it is manufactured in the safest way possible. We must make sure a lack of funding is not a barrier to getting safe formula to parents and to babies.
That is why you have the bill before you. It addresses this pressing need by providing $28 million in new funding for the FDA. This legislation will provide FDA urgently needed resources to address the shortage, to prevent fraudulent products from entering the marketplace, and to help acquire better data on the situation in the marketplace. To prevent shortages from happening again, we will strengthen the workforce focused on formula issues and increase FDA inspection staff.
Meeting this need today is necessary to ensure that no baby goes hungry and no parent has to struggle to find the food to feed their child. And our efforts for the future will help ensure we are never forced back into this disappointing situation.
Furthermore, I intend to address the terrible safety issues that led to at least two babies dying and several others being hospitalized, which is why I released a whistleblower report which highlighted a damning list of allegations of wrongdoing at the Abbott Nutrition factory, in Sturgis, Michigan, producing a formula, that they knew, in fact, was contaminated-they falsified records, they didn’t test the seals on the cans properly, they sent untested infant formula into the commercial market-that’s just to name a few of the infractions.
Abbott has been putting production and profits before people, and it is wrong. We must simultaneously find solutions that prevent this contamination and shortage from happening again. We should not have to choose, and parents should not have to choose between food safety and supply. I reject this dangerous and false dichotomy. Our work here is not done.
I am proud to be here today because the bill meets the moment, keeps our babies fed, and I respectfully request an appropriate rule for Floor consideration of this critical legislation and look forward to answering your questions. Indeed, in fact, there is a description of how the money will be spent.
Infant formula and supply chain monitoring and assessment, health fraud state partnership’s laboratory methods, the Office of Regulatory Affairs, social media data analysis to identify unsafe infant formula products - that’s going to the Center for Food Safety and Applied Nutrition-infant formula staffing needs going, $23 million.
At the moment, understand that the CFSAN Office of Nutrition and Food Labelling - infant formula - this is the group that examines the submissions of infant formula when the submission comes from a domestic source or a foreign source. They have nine employees. They do not have the inspection staff to go out to a non-FDA-approved facility to do the proper inspections so that in fact they could get on an FDA-approved list.
By not investing this, we are then complicit in what has been an outrageous failure. I will not sit here and not say that while Abbott, a bad actor, will be investigated and that investigation will lead to accountability. And by the same token, I’m not afraid here to say today that the Food and Drug Administration, which knew about or at least had information about contamination from last October, dragged their feet in doing something here.
And that is why we want to try to provide the opportunity for being able to import a product from an FDA facility, approved FDA facility, to provide us with product that we can then get put on the shelves. That is a moral responsibility to get product on the shelves.
No matter how you feel about any agency or any manufacturer - both of whom are culpable in this effort. It is our job to make sure that the product is there so that mothers and fathers are not worried that they can get it and by the same token are worried that they may provide a contaminated product to their baby.
I thank you for the opportunity to be here today.
Source: U.S. Department of HCA
