Scott Questions FDA Commissioner on Baby Formula Shortage

WASHINGTON – At today’s Senate Health, Education, Labor, and Pensions Committee hearing, U.S. Senator Tim Scott (R-S.C.) questioned Dr. Robert Califf, Food and Drug Administration (FDA) commissioner, on how to help families struggling with the baby formula shortage and keep a similar crisis from happening again.

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Read the full exchange below:

SEN. SCOTT: Thank you, chair, and thank you, ranking member, for holding such a really important hearing. One of the things as I’ve watched this hearing all morning, frankly, I keep hearing is ‘who should be to blame for what didn’t happen?’ And the one thing I think Americans are really not very interested in is to watch each side pointing fingers at the other side.

Some say it’s the private sector. Some say it’s government. The fact of the matter is that the average person in this country is not as interested as we are in figuring out how to make a Republican responsible for what happens or the Democrat to be responsible for what happens or the private sector to be responsible happens. This, frankly, seems to be an all-hands-on-deck kind of problem. Everybody did something that they ought not have been doing or didn’t do enough of what they should have been doing.

So from my perspective — I’m not sure your opinion on that — but the fact of the matter is it’s pretty frustrating for the average person in our country who’s sitting at home watching a crime wave that they haven’t seen in decades, looking at the price of gas at the pump, and they’re scratching their heads and they’re digging into their pockets and they’re coming up a little too short, a little too often month in and month out. And then they see the absolute crisis of inflation that is weighing on their shoulders and their inability to meet the needs that they were able to meet just eighteen months ago. And then finally, for mothers, fathers [of] new kids, they see this shortage of formula that seems to [exacerbate] their situation in such a way that they simply can’t imagine it happening here at home in America.

And Dr. Califf, I hope that we spend less time pointing fingers at who’s to blame and take responsibility for where we can make things better. You’re a South Carolinian, born in Anderson, South Carolina. … The truth is that too many Americans in too many places and specifically at home are looking at the crises that befall them and they want solutions, not really the blame game. So I hope that we spend a few minutes on ‘how do we make sure this doesn’t happen again?’

But before we get there, I want to highlight the fact that in your home state … and my hometown of Charleston, South Carolina, we have four babies in hospitals due to the shortage because they have had an allergic reaction to the generic forms so they need a specialized formula. What can we do to accelerate the path to those families having what they need and how can we ensure that this doesn’t happen again?

DR. CALIFF: Well, to your first question of what can we do for those specialty formulas, as I reported, we have groups of FDA people — pediatricians and specialist in critical care — who meet every day and talk about each case and try to get the right formula to the baby. In the case of Abbott, which was the major manufacturer of these, for their hyper specialized formulas that had no substitutes, we actually have allowed on a case by case basis the formula to be sent out after careful weighing of the risk and benefit since they were made in an unsanitary plant.

For the next tranche that you’re describing, it’s right to try a different brand, which is considered to be interchangeable. But we all know that when it comes to a particular drug, for example, sometimes what looks like the same thing doesn’t sit well. And then what has to happen is trial and error, but there are specialists involved every day in helping to navigate these. You have great ones at MUSC. I know the institution well. And, you know, I’m sorry that people, infants, have to be in the hospital, but for that kind of critically dependent infant, it’s probably the best place for them to be until we get everything back and running.

SEN. SCOTT: And transitioning into the latter question as relates to ‘how do we ensure that this doesn’t happen again?’ The safeguards, the whistles, the bells that should be going off when we are at 11 percent, shortage 20 percent shortage, 30 percent shortage, 40 percent shortage. How do we look back and learn lessons that we use for the future?

DR. CALIFF: Well, you know, there’s an old saying ‘there are lies, damn lies, and statistics.’ So Senator Cassidy and I have very different data. He showed the most extreme estimate. Our estimates are nowhere near what he showed. But having said that, we have a very specific list, some of which are in consideration in upcoming legislation that we’re glad to share with you. The big question that I think is going to have to be addressed is ‘do we create a stockpile as a backup in case something doesn’t work in the future?’ I do worry what happens is that we’re getting the Abbott plant back up and there are positive cultures, would be one example. I think we’re going to have to have a surplus. We’re certainly planning on a surplus within a couple of months, as I’ve already told you. The question is, should we maintain that surplus as a government activity for the foreseeable future? And that’s a question we’re all going to have to discuss together and make a decision about.

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