Roles of Federal Agencies in Helping Address the Infant Formula Shortage


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The Department of Health and Human Services has new authorities to hopefully help solve the national formula shortage. This is after President Joe Biden invoked the somewhat rarely used Defense Production Act last week. But it’s unclear exactly how HHS will use these newly delegated powers and what help they might provide. Meanwhile, a lot of questions about the crisis on Capitol Hill, and that’s where the Federal Drive with Tom Temin found Mitchell Miller of OMCP. And he offered a preview of what to expect on the Hill this week.

Jared Serbu: Hi Mitchell.

Michael Miller: Hello everyone.

Jared Serbu: Let’s start with the problem of the formula. Best we can tell, where are things right now, both in terms of the administration’s response and any way lawmakers might seek to intervene or at least exercise oversight?

Michael Miller: FDA Commissioner Robert Califf said improvements were on the way this week. And he told members of an angry House panel last week that it could be several weeks before parents actually start seeing formula on the shelves the way they’re used to seeing it. And that, of course, goes back to problems at Abbott’s production plant in Michigan. Lawmakers on both sides are still very upset that the FDA has said it’s been slow to respond to these issues they say they’ve known about for months. Now, for its part, the Biden administration has launched a program to use military aircraft to import formulas from foreign manufacturers. Typically, during a regular part of the year, roughly 98% of infant formula is manufactured and distributed here to facilities in the United States. So it’s a big change. And the House also passed a bill to provide the FDA with $28 million last week, but it is unlikely to pass the Senate. Now the Senate has joined the House and approved changes to the WIC program for low-income women. Basically, it allows them to go to other baby formulas, if you want. Normally they have to get a specific USDA approved one. This relaxes the regulations related to this. So that was an area where both the House and the Senate were on the same page. But also, as you know, within the FDA there’s a lot of angst, frankly, within the agency about how things are being handled. Now Commissioner Califf has appointed Janet Woodcock, who is deputy commissioner and former acting commissioner of the FDA, to play a bigger role not only on this issue but on other major food issues. But consumer advocates have criticized this. They say his expertise has really been more related to drug approvals. Many outsiders say the FDA needs to do a lot more within the organization to get ahead of some of these big issues.

Jared Serbu: Well, you could be a little clearer on, insofar as there has been finger pointing and direction from the FDA, what exactly is the criticism? What do the pointing members of Congress think they could have done better to avert this crisis?

Michael Miller: Well, what they’re saying is that there were starting to be rumors of trouble dating back to last fall. And then when it really hit the fan was in February when you had issues specific to the Abbott facility, which unfortunately it appears at least two baby deaths are related to some sort problems with the factory and security issues there. And what they’re saying is that, as early as February at least and maybe even beyond, the FDA should have taken a much more aggressive look at what was going on at that plant. Eventually, of course, the FDA shut down plant operations. But they argue there really was no longer-term plan to get the plant back up and running, or to figure out with all the supply chain issues that escalated what they were going to do to actually supply. formula milk to people. And then of course, obviously, it just blew up when people went into stores and didn’t see it. And I’ve spoken to some lawmakers about it. I spoke to Senator Tim Kaine from Virginia, and he admitted that Congress was frankly slow to recognize this, he said that he himself had only really realized that there was a problem that there about a month old. So I think in a lot of these cases there’s a lot of blame to blame.

Jared Serbu: Let’s zoom out a bit and talk a bit about the legislative calendar here. I know it has been a busy few weeks of congressional hearings on both the House and Senate side. I think the House has actually been absent for at least a while. Is this the kind of sign that things are getting closer to election season and the outlook for legislation is darkening?

Michael Miller: It really does look like that, Jared. I mean, right now you have this week the house is out. They will be back in the Senate. But right now, there’s really this feeling that what’s actually going to be done? And there really isn’t a good sense of optimism about a lot of things being achieved. Of course, last week the Senate followed the House and passed the nearly $40 billion in aid to Ukraine. It’s obviously dominated a lot of things, but in terms of federal agencies and things that are actually being done at the more traditional level, it’s been really slow, especially even for a midterm election year. Clearly, congressional Democrats have been trying to push through some sort of reconciliation measure for months, but they keep hitting the stop sign. Some of them say the stop sign is Senator Joe Manchin. Anyway, there doesn’t seem to be even piecemeal legislation that they’ve been talking about, whether it’s to increase the number of child care centers or to increase funding for child care centers or to reduce the price of prescription drugs. Many of them are the subject of much discussion among congressional Democrats, but realistically there is simply no way forward. You have a 50/50 Senate. And of course you need all 60 votes to overcome the filibuster. So I don’t see much optimism that any bill will pass. And then if we go to the basics, the workings of congressional budgeting, you have the four corners, you have the officials saying, really now for many weeks that yes, we are slowly making progress here. But there wasn’t really a watershed moment where we thought okay, now they’re finally getting to the next year’s budget. It is still very early in this process. And as you know, in years past, they usually don’t get a lot of these major bills through in a midterm election year.

Jared Serbu: Yeah, and I think people are pretty used to living under [continuing resolutions] for at least the first few months of each federal fiscal year. Is it basically just a certainty, especially with the election year that it will still be the case, for this year?

Michael Miller: I think there is no doubt about it. I mean, the CR is going to be back, we’re going to see a little bit of optimism here and there, and then it’ll all fall aside as usual. So we’re going to be looking at a rolling resolution towards the end of the year and there just isn’t enough agreement on either side. I mean, there are people who think they could go ahead and maybe push through a few spending bills, but that would be even more optimistic. So I think we’re headed to those two familiar letters: CR.

Jared Serbu: And I know one agency budget in particular that you’re watching is the IRS, which the president has proposed, I believe $80 billion in new funding for, and in the meantime, also scrutiny of [the Government Accountability Office] on this agency. What are you looking at over there?

Michael Miller: To the right. Congress has really been all over the IRS, as you know. And as Federal News Network reported last week, this new GAO report is out. This was requested by Idaho Senator Mike Crapo, who is the top Republican on the Senate Finance Committee, very concerned about, especially with Republicans, whether the IRS was digging into too much in some personal things related to the people who filed and if people had gone too far in that. Now this GAO report found that several hundred IRS employees over a decade violated various policies [into] unauthorized access to taxpayer information. In some cases, they simply don’t know exactly what was found, or in particular why it happened. The IRS has been somewhat opaque on some of the others, on some of the issues where people, it wasn’t really clear, frankly, what they were looking for, but they may have violated a policy nonetheless. So that’s what happened, and as far as the $80 billion that the president wants, there’s just no way they’re going to get it. Lots of Republican opposition to that. The Democrats on the other side say you’re going to continue to have these problems with the IRS. And in terms of paper backups, and not doing enough audits and all that, that IRS waiting game that we know well if you don’t provide additional funding. But right now, I just don’t see anything that comes close to that kind of funding. Although the IRS has certainly made a big effort to try to get more resources and try to reduce this paper backlog, although they have made some progress in this area.

Jared Serbu: Alright, Mitchell Miller from OMCP joins us from the capital. Thank you very much Mitchell.

Michael Miller: You bet.


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