Chair DeLauro Statement at Fiscal Year 2023 Budget Request for the Food and Drug Administration Hearing – House Appropriations

House Appropriations Committee Chair and Labor, Health and Human Services, Education, and Related Agencies Subcommittee Chair Rosa DeLauro (D-CT-03) delivered the following remarks at the Agriculture, Rural Development, Food and Drug Adminstration, and Related Agencies Subcommittee's Fiscal Year 2023 Budget Request for the Food and Drug Administration Hearing:

Thank you, Chairman Bishop and Acting Ranking Member Harris for holding this important hearing and I want to say thank you to you Commissioner Califf for testifying this morning.

We are dealing with an infant formula emergency in this nation a crisis of both safety and supply. I sounded the alarm on this crisis and have been working on this issue since news of the recall broke in February. I am glad that you are testifying before us today because we need to get to the bottom of the disgraceful lack of oversight and the terrible safety issues from an Abbott Nutrition manufacturing plamt that led to at least two babies dying and several others being hospitalized after consuming Abbotts infant formula.

We need to also get to the bottom of the FDAs slow response, which contributed to products staying on the shelves and in the homes of families the country over, potentially putting babies at risk and forcing parents to play a game of Russian roulette that they did not know they were playing.

I want to say a thank you to Chairman Bishop, for holding this hearing and for your longtime leadership on this subcommittee. In September 2021, FDA inspectors conducted a routine inspection of the Abbott Laboratories facility in Sturgis, Michigan, where suspicions of wrongdoing were already present, as noted in a Bloomberg article, published 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 Abbot. Recalls happen, but, if the allegations are true, the company has lied, cut corners, and falsified records to cover up their misdoings at the sake of infant health and retaliated against employees who tried to correct the problems they were seeing. They knowingly put a contaminated product on the market, that is plain wrong.

The FDA knew about what Abbot was doing in October. But not until late December did 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 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 and submitted for the record the whistleblower report, with the truly awful allegations against Abbott. Their wrongdoings include the falsification of records, testing seals on empty cans, and releasing untested infant formula, just to name a few.It all begs the questions why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves? How many more illnesses and deaths were caused due to the FDAs slow response? Who received the report at the FDA? What did they do with the report? Who in the leadership had access to that report? Who didn't have access to that report? And why was there no reaction?

And it makes me question which side the FDA is on. Are they on the side of Abbott and industry or on the side of the American consumers, in this case babies and their moms and dads?

We must get to the bottom of the food safety issue. But today, we are also dealing with a serious infant formula shortage in this country where parents, many of whom struggling, are now scrambling to find the formula to feed their babies. This shortage was caused in large part by the lack of action by the FDA and by corporate greed and consolidation, in this case Abbott putting profits and production over people. This should not happen in the wealthiest nation in the world. And there are two parts of this shortage safety and supply. We cannot and should not have to choose between the two, and I reject this dangerous and this false dichotomy.

President Biden just announced that he will be invoking the Defense Protection Act to increase domestic production of infant formula and 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. That is the direction that we need to go in. That is what I hope is being planned. These steps can help us achieve the goal, and I applaud the first steps.

This week, and we passed last evening a bill to deal with a portion of this effort. Last night, we voted on a bill to provide $28 million in new funding for the FDA 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 work to strengthen the workforce focused on formula issues and increase FDA's inspection staff. But as the Ranking Member has pointed out, funding is not the only answer. This issue goes beyond funding. And that has to do with a structural problem. For another time I would want to discuss the need for a Deputy Commissioner for Foods, where accountability to the Commissioner and have direct line authority over the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and food related components and operations of the Office of Regulatory Affairs. This should happen immediately and the person who is appointed needs to have relevance and appropriate food credentials. Someone with that background who understands this issue.

I understand that the FDA has begun to take action to address the shortage, which is encouraging. I remain concerned about the safety of the formulas that end up on our shelves. As I have said, we cannot be forced to make a false choice between safety and supply. I am disappointed that the FDAs recently released guidance does not go far enough to ensure formula is safe for our babies, because the food we feed our babies must be the safest product on the market. Which is why I want to focus on FDA-approved facilities because we have a standard, that may not have been Applied to Abbott, but we have a standard. When people grab a container of infant formula from the shelves, I want them to know they do not have to play a guessing game. I want them to know that they can have confidence that it is safe.Commissioner Califf, I hope that you have been able to reflect on what went wrong and with that come with answers because we are all waiting for them. We need to get to the bottom of this terrible tragedy to prevent anything like this from ever happening again.

Thank you again, Chairman Bishop and Acting Ranking Member Harris. I yield back.

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Chair DeLauro Statement at Fiscal Year 2023 Budget Request for the Food and Drug Administration Hearing - House Appropriations