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The FDA commissioner talks about the latest on the baby formula shortage

CHERYL CORLEY, HOST:

This may not be a surprise to anyone who's still anxiously trying to track down baby formula, but there's still a shortage. The Food and Drug Administration loosened restrictions on foreign-made formula. President Biden invoked the Defense Production Act to produce more but still short supply. So a look back and a look forward - how did we get here and when will it all in? For that, we're joined by FDA Commissioner Dr. Robert Califf. Commissioner, welcome.

ROBERT CALIFF: Thank you so much. Glad I can be with you today.

CORLEY: As you know, there's been quite a lot of anxiety over the shortage of formula - infant formula since May. Factories have boosted production. Additional formula is being shipped in from other countries. Tell me, have you seen any improvements? Can you kind of quantify the shortage?

CALIFF: Yes, we can. And as you may know, the ideology of this, beginning of this was when one of the major production plants in Michigan had quality problems and had to shut down. And it was supplying up to 40% of the total formula for the country. This created quite a deficit, which really became a serious problem in May. And ever since then, the industry has really stepped up. You've already enumerated the things the administration has done, including bringing in foreign formula. But our domestic producers have also gone to 24/7. There is a backlog of - as you know, the formula gets made, it gets sent to a distribution center and then distributed to the stores. And so there's a backlog that's having to be filled out. But we are seeing measurable improvement. There's more formula on the shelves, and the production now is exceeding the demand by a significant amount every week. So we're on the road to recovery, but I don't want anyone to think we are sitting back at this point. We're still going 24/7, seven days a week to make sure that we stay on the road to recovery.

CORLEY: Why - you say, you know, people are really working hard to kind of resolve this, but why has the shortage gone on this long? And if it is 24/7, what else is needed to get back to full supply?

CALIFF: Well, there are really two factors there. One is the total amount of formula, and that's where we're making a lot of progress. But the other thing that I want to make sure people realize is that what the manufacturers do when they need to rev up their production is they reduce the number of types of formula that they make. Whereas they may have, let's say, been making a one-pound, a five-pound and a 10-pound pack, they may reduce to just one type so that they can be as efficient as possible in turning out the formula. That leads to a situation where even if there's adequate formula, there may be empty spots on the shelves simply because that type is not being made. And so that's not to say that we're where we need to be. It's just to say that some of what you're seeing is not just due to a shortage of formula. It's just that type of formula is not being made.

So what we need is just to continue for the next six to eight weeks for the production to far outstrip the amount that people need for their babies. And then we'll be back in good shape with regard to volume of formula. But to keep this from happening again, we need to change something else, and that's to diversify the production so that it's more resilient, so that if there is a problem in one place, it doesn't create a situation like this again.

CORLEY: Yeah. As you know, and as I think everybody knows these days, just a few companies do control the infant formula industry. And that plant in Michigan, as you mentioned, a huge part of why this crisis occurred. And you acknowledged early on that the concentration of the formula industry really deserved more scrutiny. So what is the FDA doing when it comes to diversifying the market? And, you know, will any change kind of be permanent to allow for more companies to make formula?

CALIFF: Well, I'd stress this is really administration-wide. I mean, everybody has pitched in to help out here, including the strategy going forward. And I'll point to three things quickly. The first, we are encouraging people to increase the different sites within the United States, more producing facilities. The second is with the foreign manufacturers that are now importing under our scrutiny with high-quality formula, we want to create a situation where they can stay on the market. You know, right now, we've expedited the paperwork, but they'll need to go through all the usual standards, just like a domestic producer will do. And the third component is we need to monitor the system more closely. And there's legislation in front of Congress that would help us be able to keep track of things better so that we can pre-empt these problems rather than waiting for them to happen.

CORLEY: Well, I'm going to bring you back to that focal point. What do you say to the parents who may be listening, who are just still struggling to find a formula for their baby?

CALIFF: Well, I'd say, first of all, we're aware of the difficulty that you're having. We're doing everything we can to remediate it. We're on the way to success. And it is going to take a little while longer. I do want to put in one particular thing that I think is very important for people to know. Some parents deal with infants who can't tolerate normal formula, standard formula. And they're - the shelves are most - having the most difficulty with the specialty formula. But I want to let people know that, you know, this is mostly because the largest maker of specialty formula was that plant in Michigan, which is now up and running again. It's going to take a while, but there is a supply at Abbott. For parents having trouble finding that special formula, you can just go to the HHS website, hhs.gov/formula, and you can get the phone number for Abbott, call directly, they'll ship the formula to you. So there is formula there. It's just not on the shelves the way we hope it soon will be.

CORLEY: All right. Well, thank you very much for that information, sir. That's FDA Commissioner Dr. Robert Califf. Thank you for your time.

CALIFF: Thank you. Transcript provided by NPR, Copyright NPR.