Abbott shut its Sturgis, Michigan plant in February 2022 and recalled the formula made there. By May, parents were driving for hours to find any. On May 25 the House Energy and Commerce oversight subcommittee took two panels in one day: FDA Commissioner Robert Califf in the morning, and in the afternoon, under oath, executives from Abbott, Gerber and Reckitt. Chair Diana DeGette began by reading the dates back to the commissioner. The bacterium at the center of the case, Cronobacter, is rendered throughout the transcript as Ceronobacter.
The timeline, read back
DeGetteBut I want to make sure that we are all on the same page. And I just want to go through the timeline that was presented in your written testimony--and you referred to it, too. From September 20th through the 24th on 2021, FDA did a routine inspection of the Sturgis facility. And then, coincidentally, on the same day, September 20th, FDA got news of a complaint about an infant that--who had become ill due to the Ceronobacter after consuming infant formula produced at that Sturgis facility. But then a month--about a month later, FDA got a complaint from a whistleblower about the lax cleaning and testing facilities at Sturgis, as well as alleged falsification of records and deception of FDA inspectors. But that person was not interviewed until two months later, in December. Then, between December and February 2022, FDA received three more consumer complaints regarding Ceronobacter cases, two of which, sadly, resulted in death. But then, despite all of this, FDA didn't return to inspect the Sturgis facility until January 31st. Then, according to your testimony, there was a six week inspection and there were fundamental sanitation, building, and equipment issues. But then, February, Abbott closed down the plant at Sturgis and ceased production. Then two days later, finally Abbott voluntarily recalled the products. Well, so then, on March 18, FDA closed the inspection and issued its inspection observations to Abbott. But then, finally, on May 16th, FDA and Abbott signed a consent decree providing numerous steps that Abbott needs to undertake. You referred to that. So that was May 16th. But now Abbott is telling me it is going to take two weeks to clean the plant, then it is going to take up to six to eight weeks more to get back to full production. And so, Commissioner, this is what I am concerned about. I went through this whole timeline because, by my account, it took about four months from when the agency first became aware of these reported cases of Ceronobacter to inspect the Sturgis plant. Then it took two more weeks for Abbott to stop production, and then it took three months more for FDA and Abbott to enter into a consent decree. Does that sound about right to you, in terms of the timeframe?
CaliffI think you have got it right.
DeGetteDoctor?
CaliffAnd as you know----
DeGetteOK.
CaliffIt is all documented in your--in the testimony in great detail.
DeGetteSo I guess you referred to this, that you have somebody looking into it. Do you have any idea why it took so long from the report to the inspection and recall? And what is the plan to shorten the time in the future?
CaliffWell, first of all, let me say you are right to be concerned, and the public should be concerned. As I have said already, it was too slow, and there were decisions that were suboptimal along the way. And I am sure you also know that, as I was going through confirmation, I got many calls from people concerned about the food side of the FDA because of the lack of resources and concerns about the organizational structure. My basic plan has been to get through this crisis, and then we will be looking at the overall food program from the perspective of reforming it, but not waiting to deal with the specifics of this case. This is where Dr. Solomon, who is a truth teller in the FDA and well known by everyone, will lead an effort to help us get the processes corrected.
DeGetteBut what I do want to say is that I have been on this subcommittee for several decades now, and the food program at the FDA has--it crops up time to time. We had the peanut butter crisis. We have had many, many crises over the years. And we always rush to make that plant safe, clean it up. But ultimately, what we have to do is we work to--have to work together--and I think you agree with this--to put food back into Food and Drug Administration. We have to not just throw money at it. We have to figure out what we need to do to make these inspections robust, and then to shorten the time. Would you agree with that?
CaliffI 100 percent agree, and applaud you for what you did with 21st Century Cures on the medical product side. We need the equivalent on the food side. I think the medical product side is doing really well at this point. The food side needs a similar shot in the arm.
[Hearing transcript, May 25, 2022, questioning by Chair DeGette, first panel.]
Yes or no
GriffithAnd Dr. Califf, thank you so much for being here. This is not going to be an easy hearing, and I respect you for showing up to take the tough questions on. And that means a lot to me. That being said, I know it is not what you intended to say, but I think some could take the impression that, in part at least, you were blaming moms and dads who were scared that their children couldn't be fed, and that they were over-buying. And the answer is not that moms and dads are responsible for this problem. It is the manufacturers of the infant formula and the FDA. So I think that is important.
GriffithNow, you have said it was too slow, and that is where I was going to go with that. And I think it is pretty clear, whether it was September that they started meeting or December, when you have a problem that is identified in September--I am glad that you have already agreed that getting to do an inspection on January 31st is too late. And you stand by that, that you--you agree that was too slow.
CaliffYes.
GriffithYes or no?
CaliffYes.
[Hearing transcript, May 25, 2022, questioning by Rep. Griffith, first panel.]
The deputy commissioner who never got the report
Frank Yiannas was the FDA’s Deputy Commissioner for Food Policy and Response. Representative Gary Palmer had that morning’s Washington Post in front of him.
PalmerYou are the Deputy Commissioner for food policy and response, yet neither of the FDA's food policy divisions report to you, nor do the food safety inspectors. Is that true?
YiannasThat is true.
PalmerBefore Commissioner Califf was appointed, food safety problems were reported to the principal deputy commissioner, Janet Woodcock, who is a medical doctor who was acting commissioner when the whistleblower complaint arrived. When you did--when did you get access to that report?
YiannasThe whistleblower report, I believe, I got access to it around February 10th, thereabout.
PalmerBut the whistleblower report had been out for months. Is that correct?
YiannasYes.
PalmerWhy is it, then, if you are the deputy commissioner for food policy, you didn't get the report? How is it that it got tied up in the bureaucracy, and it didn't get to the person who arguably should be responsible for responding to it?
YiannasYes. I am not sure why the report wasn't shared with me, and how it didn't get escalated. As you have heard the Commissioner State, I know that there is going to be a review, and we are going to try to get to the bottom of it.
PalmerI know Commissioner Califf was not there when this occurred, but this is stunning to me. I mean, Commissioner Califf, is this typical of how whistleblower reports are handled, that you don't get them to the right people?
CaliffWell, of course, I haven't been involved in whistleblower reports until just the last three months, but we've already done a pretty extensive review of it. There were five whistleblower reports----
PalmerThat is not my question sir, that is not my question. My question is you have the deputy commissioner for food policy and response, who basically was shut out of the process. And you know, the old saying in management that personnel is policy, and--but it is also management structure.
PalmerMr. Yiannas, I understand you were working on unifying the food program at the FDA to ensure that failures such as that have led to the baby formula supply crisis wouldn't occur again. Have you been aided or impeded in that effort?
YiannasWell, we've had a collaborative effort--yes, hopefully you can hear me. Thank you. We've had a collaborative effort. We knew that responding to outbreaks fast and being right was critical in this new world and so last year----
PalmerYes, but what I am asking you is----What I am trying to find out is that, according to the Washington Post, you were told to stand down in that effort to reorganize this so that you could actually do your job, and have the FDA organize in such a manner that--and this is my opinion, this is not the Post. But in my opinion, the FDA focuses more on medical issues than they do food issues. And that is what Ms.--Representative Schakowsky brought up. Were you impeded in that effort?
YiannasI could answer the reference to the Washington Post, because that was very unethical and egregious behavior. I was called on my FDA personal mobile. The person identified themselves as Kim, somebody who I work with regularly, similar voice, asked a question and I answered it. They didn't identify themselves as a reporter.
PalmerOK----
YiannasBut no, what that article referenced was that the investigation is going to be led at that time by Principal Deputy Commissioner Janet Woodcock. And as you heard today, Steve Solomon is going to now be leading it.
[Hearing transcript, May 25, 2022, questioning by Rep. Palmer, first panel.]
The kitchen next door
DeGette’s last question of the morning was about the fact that the bacterial strains found in the sick infants did not match the strains found at the plant.
DeGetteBut I want to make sure that we don't leave anybody with the impression that makes--that that means that there was no contamination at the facility, or that there is no problem. Can you talk again, Dr. Califf or whoever, about the problems that were found, and why it was necessary to take the actions the FDA did?
CaliffSure. First, as we said before, the absence of being able to prove that there was a connection doesn't mean that there was no connection. We just can't rule it in, nor can we rule it out. And of course, when you make a conclusion there is a connection, that is a major thing, and you have to have the evidence, and we don't. But that is totally--that clued us in to what needed to be done, and we went to the plant.
CaliffI mean, I have thought about it. Let's say you had a next door neighbor who had leaks in the roof. They didn't wash their hands. They had bacteria growing all over the kitchen. You walked in, and there was standing water on the counters and the floor, and the kids were walking through with mud on their shoes, and no one cleaning it up. You probably wouldn't want your infant eating in that kitchen. And that is, in essence, what the inspection showed.
CaliffI want to emphasize, again, I think Abbott is on the way. I think they are working very hard. This is not emblematic of the Abbott that I have known as a cardiologist. So I am optimistic, as Mr. Upton said, that we are going to get over this. The people who work in that plant I know are hardworking people, and we are not meaning to castigate them. But these are just the facts that we saw.
[Hearing transcript, May 25, 2022, questioning by Chair DeGette, first panel.]
The second panel, under oath
After a ten-minute recess the subcommittee swore in Christopher Calamari, who runs Abbott’s U.S. nutrition business, alongside executives from Gerber and Reckitt.
DeGetteI just can't understand why this factory in Michigan had such substandard health conditions when it was inspected in January. And I am wondering if--as well as all of the things you talked about that the company is doing to try to get formula out for families, what new provisions have--and protocols has the company put into effect to ensure that we don't get into a situation like this again, where a major production facility has to be closed down?
CalamariChair DeGette, thank you for the question. I was at Sturgis last week, and I can tell you the staff there, the team there, they make formula as if it were for their own families. And they--after the FDA identified observations where we needed to improve, and we are--we needed to address, the teams have been actively working on taking steps to address those issues.
DeGetteMr. Calamari, maybe you don't understand what I am asking. I know you are trying to clean it up and get it back open, but what additional protocols are you putting in place so that we don't have this happen again?
CalamariAbsolutely. So for the 483, it did identify clear observations which we needed to address. So some of those key areas that we are improving are including in the installation of non-porous flooring; where information of--improvements across different processes and traffic patterns within the plant; additional training of employees to address some of the observations that were identified. So our improvements range from the physical to the process, and all throughout the facility.
DeGetteAnd are you institutionalizing that for the future, not just to remedy these deficiencies?
CalamariChair DeGette, yes, we are.
[Hearing transcript, May 25, 2022, questioning by Chair DeGette, second panel.]
Have any heads rolled
GriffithMr. Calamari, I think you are a good guy in a bad spot, but I am going to ask you some tough questions. So here is the deal. I think you got more than a porous floor problem, or a roof problem at Sturgis. When you look at the FDA reports over the years, and you see similar problems occurring, and then you read the whistleblower report, which says that members of your team at Sturgis were hiding information from your office, from the home office, that could lead to some of the problems that the FDA has mentioned in their testimony and that you know about, it seems to me that you have a culture problem. What steps are you taking to change that culture, and have any heads rolled?
CalamariSo, Representative, thank you for the questions. I think there are a couple pieces there. First, on the culture problem, I don't think it is a problem. I think--we were there last week. And I saw generations of employees who worked--who work in Sturgis with pride, who feed their own families. And they are committed to making steps to improve. And we are making those steps to address in the plant, physically, processes.
CalamariAnd Representative, we are going to learn from this. We are going to get better as a result of this. The pride we have feeding families for decades, this has been an opportunity to improve, and we are going to do so.
GriffithBut the FDA commissioner said that is what they found, that your folks didn't seem to think that was a problem at the Sturgis plant, when they had roofers on the roof working around, and then they walked through the food production section with mud on their feet. And so, even if a whistleblower is wrong, and they weren't hiding stuff from you, when you see things like not inspecting the cans at the proper time, and when there is food in the seams--could be getting in the seams later, causing a bacterial problem, and you see muddy feet walking through, it doesn't take a food scientist to figure out you don't want going through a facility like that somebody who has got muddy feet and just came off the roof. So I beg to differ. I think you do have a problem, but I hope you will address it. Can you at least give me a commitment that, if you see any signs of that happening in the future, that you yourself will put eyes on that problem, and try to rectify it more quickly? Because this was going on for years at Sturgis, apparently.
CalamariRepresentative, yes. Yes, we will.
[Hearing transcript, May 25, 2022, questioning by Rep. Griffith, second panel.]
When Abbott found out
BurgessMr. Calamari, let me ask you. According to Dr. Califf's testimony, an infant got sick with Ceronobacter. The powdered formula was identified as a nutritional source. And so the FDA notified Abbott the third week in September. Is that correct?
CalamariSo, yes, there was a report of an infant illness in September. Yes.
BurgessYou have referenced things like the non-porous floors. We've heard about a leaky roof. Were there things that you thought maybe we ought to start seeing some of these things, or did we have to wait for a whistleblower?
CalamariWe absolutely--we have processes and protocols in place. When there is a signal for an illness, a reported illness, we have--we look to our batch records that link to that product in question. We look at the complaint rates. And we did that in this example. And there were no signals from those reviews and processes that there was anything more--anymore to the instance.
BurgessWell, OK, fair enough. So then four weeks goes by, and a whistleblower complaint is delivered to the FDA. And I presume they contacted you straight away after they got the whistleblower complaint, is that correct?
CalamariRepresentative, no. We became aware of the whistleblower complaint in the end of April, when it was made public by Congress.
BurgessSo the time lag between October and February was internal to the FDA, and not part of your normal quality assurance process.
CalamariCorrect. I became aware of it in the April timeframe, when it was made public by Congress.
BurgessThat is actually disturbing, that there was not better communication. I recognize Dr. Califf said something got lost in the mail. Absolutely unacceptable. And surely we at the Federal level need to correct that.
BurgessWell, so if the whistleblower complaint was not made immediately available to you, but then, when it was, was it your decision then to cease operations at the plant in Sturgis until you got the difficulties corrected, or was that an FDA decision?
CalamariRepresentative, regarding the whistleblower complaint, it is an ongoing review, and it is an ongoing investigation. And given the independent nature of that inquiry, I wouldn't want to speak to that. But what I can tell you is I have been at Abbott 17 years, and the Abbott I know prioritizes compliance. It encourages employees to speak up.
[Hearing transcript, May 25, 2022, questioning by Rep. Burgess, second panel.]
And so it failed
RiceMr. Calamari, if I could just continue along the lines of--I just want to clarify. You were informed of the whistleblower and their report. They went directly to another source. They did not go to you. Is that right? With the problems in----
CalamariYes. I would have become aware in the end of April timeframe.
RiceSo tell me what--I mean, what system do you have in place to ensure that things like this don't happen, and that you are leaving it to a whistleblower to bring it to the public--to Federal agencies' attention in order--before you can--before you even know about it? I mean, what are your procedures that you have to ensure that you find out about these problems first, through an oversight program that you implement?
CalamariRepresentative, I think it is a very key area you have--you are commenting on. We do have a process in place where employees can raise their voice, and speak up, and----
RiceTalk about that. What is that process?
CalamariSo it is independently administered. So there--it respects the confidentiality of the employee, and it is administered through part of the organization outside, you know, that is set apart and independent, so that any questions and inquiries can be independently administered and reviewed.
RiceAnd are people made aware that they have this avenue to report things that they see within a facility that they think are--is not right?
CalamariYes, they do. We encourage employees to speak up, and we--and safety and compliance is a top priority.
RiceSo why was this not brought directly to your attention?
CalamariRepresentative, this--the nature of this process is this--when it was made public, it was shared with FDA. And I was not directly aware of the investigation until that time.
RiceWell, I guess I am--my question is, if you have what you are describing as a specific program to allow employees to go directly to someone within the company to register an issue with something that is going on in any one of your facilities, why didn't that happen here?
CalamariRepresentative, what--I just want to make sure I--when I say Abbott did not find out about it until the--it was made public in the end of April. And it was the--the particular individual who raised the complaint, it was their choice to use that mechanism to raise the complaint.
RiceOK. So what are you going to do to ensure that people go to you first, and not do what they did--have to go to take the steps that they did here? Because these--it sounds to me like this is not an isolated incident. These things have happened at your facilities. Maybe not this specific thing leading to this incredible shortage of essential nourishment for babies. But why did your system fail here? And what are you going to do to make sure that it doesn't happen again, that this--that there is a quality control within your company that employees respect and believe is going to be effective and not come back on them?
CalamariRepresentative, we encourage employees to speak up. We are going to reinforce that we are a culture where we support employees to raise concerns if they see them. And I think that is one of our ongoing commitments as an organization.
RiceDo you offer any kind of reward for people who bring this information forward, to actually encourage people to be on the lookout, and to not fear coming forward to higher-ups in the company?
CalamariWe encourage it by reinforcing that their voice counts, that we have a zero-tolerance policy for retaliation against these types of complaints. And that is our commitment to support those employees to speak up.
RiceAnd so it failed. Clearly, you are not getting that message out to your employees, or you would have been aware of this before anyone else was. Would that be correct?
CalamariI think it is always important that we could always use this as an opportunity to reinforce our principles. I will say that the individual chose to raise their concerns in this matter, and I think we have to--you know, we have to revisit how we make sure we get--reinforce that we are a culture of speaking up and supporting training and compliance.
RiceAre you just making that decision now, or is this something that you were aware of before me asking you these questions? You--do you understand that that is something that you have to work on in your company?
CalamariRepresentative, absolutely. We are committed to those principles.
[Hearing transcript, May 25, 2022, questioning by Rep. Rice, second panel.]
The market, in four questions
Representative Billy Long asked all three executives the same thing.
LongFor Mr. Calamari, prior to Abbott's recall in February, what percentage of Abbott's total U.S. infant formula was made in your Michigan facility?
CalamariApproximately 40 percent.
LongAnd prior to the recall in February, what percent of the U.S. market did your company's infant formula produce or account for?
CalamariAbbott is approximately 40 percent of the market.
LongPrior to the Abbott recall in February, what percentage of the U.S. market did your company's infant formula product account for?
FitzOur--we represent about eight percent market share.
LongPrior to the recall in February, what percent of the U.S. market does your infant formula product account for?
ClevelandWe were approximately 34 percent of the U.S. market before the recall.
LongOK, and has that changed, post-recall?
ClevelandYes, sir. With the recall, many consumers that were no longer able to use the Abbott brand switched to ours, and our share is now approximately 56 percent of the U.S. market.
[Hearing transcript, May 25, 2022, questioning by Rep. Long, second panel.]
By the numbers the three witnesses gave, one plant in Michigan had been making about 40 percent of the supply of a company holding about 40 percent of the market.