LEILA FADEL, HOST:
Abbott Nutrition, the company at the heart of the nationwide baby formula shortage, says it will reopen a troubled plant next week. But Congress wants to know why it took months for the Food and Drug Administration to warn consumers about safety lapses at that Michigan plant. A whistleblower sent a 34-page report to senior FDA officials last October. The FDA didn't investigate until January. Two House panels held hearings on the shortage yesterday, including the House Appropriations Committee. Representative Rosa DeLauro leads that committee, and she joins us now. Good morning.
ROSA DELAURO: Good morning. How are you this morning?
FADEL: I'm doing well. I hope you are, too.
DELAURO: Indeed, thank you.
FADEL: The FDA says the whistleblower report didn't reach the highest rungs of the organization due to staffing shortages in the pandemic and mailroom issues. What's your response to that?
DELAURO: Well, I think - let me be clear. We're not going to get to the bottom of what went wrong if everyone involved wants to skirt accountability. The questions today as to whether or not there's a mailroom foul up is really quite extraordinary because we know there was an email communication as well, and that was outlined and sent to specific people. So why wasn't the whistleblower contacted by the FDA until December? The mailroom is just, again, skirting responsibility, and the FDA needs to take responsibility for dragging their feet for four months and seeing that we had a company, Abbott Nutrition, that falsified their reports, the records, the testing was all falsified. They released untested infant formula. They hid information during the FDA audit, lax practices and cleanliness and a lack of traceability.
So you've got a bad actor in the company. You've got a federal agency who is responsible for regulation, the industry dragging its feet and not doing anything for four months in the meantime. We have a shortage of supply of infant formula, but we also have a food safety problem as well. And parents - it's heartbreaking.
FADEL: And you've said that you want Abbott to be held accountable. What does that look like?
DELAURO: Well, I - look, I called for - before I even knew there was a whistleblower's report, I called for an inspector general report when one of the first articles came out about this. That takes a while to occur. I want to see the investigation proceed and both - with regard to Abbott. And whatever the outcome is, they need to be held accountable for what they did. And the FDA has to be investigated as to find out what held up this critical, critical investigation so that we - there were at least two babies who died, and there are several others who were hospitalized. And we also need to take a look at the consolidation of the industry. Why does one company have 43% of the market? And why was there no contingency plan when it was determined that this was a contaminated product, 43% recall, taken off the shelf? Where was the contingency plan from Abbott and the contingency plan from the Food and Drug Administration?
FADEL: Now, last week, you introduced a bill that would provide $28 million in emergency funding for the FDA. How will that money help? What will it do?
DELAURO: Well, the FDA is - and I applaud Operation Formula Fly, which is something that I suggested. Let's bring in products from FDA-approved facilities that are overseas, and we have seven in Europe and two in Mexico. So the bulk of that $28 million is for staffing. The FDA does not have the staffing to inspect where product is coming from and to review the submissions for infant formula application. I'm introducing further legislation tomorrow. It's called Keeping Infant Formula Safe and On the Shelves Act. It increases inspection facilities, has unannounced inspections. It's more frequent audits, microbial testing so - to put regulatory practices in place at the FDA.
FADEL: Representative Rosa DeLauro is chair of the House Appropriations Committee. Thank you for your time.
DELAURO: Thank you so much. Transcript provided by NPR, Copyright NPR.
