The Office of the Inspector General released the findings and report regarding the Infant Formula Shortage and all the went into the 2022 disaster... This is a report that many have long awaited!
The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply
Issued on 06/10/2024 | Posted on 06/13/2024 | Report number: A-01-22-01502
Well, it should be no surprise that some of the statements and recommendations were included towards the FDA. Many have been addressed and are in the process of improvements.
But.... it still astounds me when I hear the true lack of... well... anything...
As the report brief overview states, "In prior work, OIG identified problems with FDA's inspections of domestic food facilities and its oversight of food recalls. We initiated this audit to examine FDA’s oversight of infant formula."
Now, before we get too far along here, I do want to say 1 thing; I do not envy Dr. Califf's role as Deputy Commissioner of FDA. It was noted during the closing remarks, how truly monumental the works and efforts he and the FDA are handling on a daily basis are! Like, I genuinely would NOT want this job. Nonetheless, Dr. Califf knew what he was signing up for, given his previous experience in working in the FDA. And as you can see in the questioning from the April 2024 Oversight Hearing,, he may or may not have known the magnitude of the problem coming at him on day 1, but it surely didn't take 2-3 months to figure it out... So, the empathy train can only chug along those tracks for so long...
So what were some of those official findings that I mention?
Lack Of Processes and Policies: "FDA Did Not Have Adequate Policies and Procedures or Lacked Policies and Procedures"
FDA lacked policies and procedures across the board when in comes to infant formula
Lack of timelines and guidelines regarding critical incidents, inspections, and recall processes.
Lack Of Organizational Structure
One of the most astonishing facts that I learned during the crisis was the fact that there was no true "Head of Foods" at the Food and Drug Administration...
Unable to make progress in many ways
Nobody was responsible for handling whistleblower reports or such information.. (at the FDA....................... )
Lack of Urgency
Largely due to the organizational structure issues, the lack of urgency during this timeframe is also truly amazing...
"took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. In addition, FDA did not escalate an October 2021 whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint."
Lack Of Authority
Unable to require reporting of contaminated products and mandate more responsibility from food companies
Lack of Monitoring
"FDA Did Not Have the Authority To Require Individuals and Manufacturers To Provide Information That May Have Helped FDA To Identify and Respond to Risks in the Infant Formula Supply"
A few other key things & statements that stuck out to me from the full OIG Report:
**These are direct quotes/statements from the report
"On February 17, 2022, after being presented with FDA sample results, Abbott initiated a voluntary recall of powdered infant formulas, including Similac, Alimentum, and EleCare, manufactured at the Abbott facility. On February 28, 2022, Abbott voluntarily expanded its recall to one lot of Similac PM 60/40 that was manufactured at the Abbott facility after FDA received an additional complaint related to Cronobacter in an infant who consumed Similac PM 60/40. (See Appendix G for a complete timeline of events. See Appendix H for events after the recall.)"
"In addition to FDA not having adequate policies and procedures for identifying and forwarding whistleblower complaints to ORA, FDA did not have adequate policies and procedures to escalate the October 2021 whistleblower complaint to senior leadership. 29 Specifically, in October 2021, the whistleblower’s attorney sent hardcopy whistleblower complaints via a courier to seven FDA employees. These seven senior officials included the Acting FDA Commissioner, the CFSAN Director, the Associate Commissioner of Regulatory Affairs, the FDA Medical Director for Infant Formula and Medical Foods, and certain ORA district directors.30 In addition to the courier mailing, the whistleblower’s attorney emailed a copy of the complaint to certain ORA district directors, ORA district staff, and the FDA Medical Director for Infant Formula and Medical Foods. The ORA district staff that received the October 2021 whistleblower complaint via email acknowledged receipt of the email on October 21, 2021."
"According to FDA officials, FDA senior leadership (including the Acting FDA Commissioner, the Associate Commissioner for Regulatory Affairs, and the CFSAN Director) did not receive the October 2021 whistleblower complaint until February 14, 2022, nearly 4 months after the whistleblower complaint was submitted. Further, the FDA Deputy Commissioner for Food Policy and Response was not notified of the whistleblower complaint until February 10, 2022. During a March 2023 congressional hearing, the former FDA Deputy Commissioner for Food Policy and Response stated, “Some individuals received copies [of the October whistleblower complaint] by emails and in hindsight, those should have been escalated to my office very rapidly.”31"
"FDA Did Not Have Adequate Policies and Procedures To Identify and Correct Infant Formula Consumer Complaint Data Inaccuracies
"FDA did not have adequate quality control procedures to identify and correct infant formula consumer complaint data that it entered inaccurately in its system. FDA did not accurately record all infant formula consumer complaint data for 37 of 63 complaints we reviewed. Based on our analysis and responses from FDA officials related to the 37 consumer complaints, we identified the following data inaccuracies:
For 32 consumer complaints, FDA did not enter information on planned followup assignments.
For six consumer complaints, the consumer complaint information FDA entered contained an inaccurate complaint result (i.e., death, life-threatening injury/illness, nonlife-threatening injury/illness, and none).
For five consumer complaints, the consumer complaint initial disposition was not updated by FDA in a timely manner to reflect FDA’s intent.
For two consumer complaints, the consumer complaint information FDA entered had incorrect data in the illness onset date field. In one instance, FDA updated the date from February 25, 2022, to January 25, 2022. In the other instance, FDA updated the date from January 20, 2021, to January 20, 2022."
"Specifically, for 3 of the 12 adverse event reports we reviewed that originated in CAERS, the adverse events reports were not forwarded to the NCCC": 39
"According to FDA officials, the January 31, 2022, inspection at the Abbott facility was a for cause inspection that met the definition of “mission critical.” FDA received a consumer complaint on September 20, 2021, associated with an infant that consumed product manufactured at the Abbott facility. About 1 month later, FDA received a whistleblower complaint on October 21, 2021, and initially contacted Abbott to preannounce the inspection on December 30, 2021.42 On December 30, 2021, Abbott informed FDA of a COVID-19 outbreak at the Abbott facility. FDA management decided to postpone the inspection because of the COVID-19 outbreak. This mission-critical, for-cause inspection was not initiated until January 31, 2022, which was 102 days (68 business days) after receiving the October 2021 whistleblower complaint."
Lovely... So What Were The Conclusions and Recommendations?
CONCLUSION
"FDA’s policies and procedures were inadequate to identify risks to the infant formula supply chain. Specifically, FDA’s inadequate policies and procedures or lack of policies and procedures contributed to: (1) delays in its response to the February and October 2021 whistleblower complaints, (2) investigators not receiving information from a relevant consumer complaint while they were conducting an inspection, and (3) investigators not knowing how and when to initiate the 2022 for-cause inspection during the public health emergency. FDA should improve its inspection and recall processes to better ensure the safety of the infant formula supply.
If FDA had adequate policies and procedures, it could have identified underlying problems at the Abbott facility and required Abbott to correct them. Although FDA took some action during the facility inspections and conducted followup inspections in accordance with Federal regulations and internal policies and procedures (Appendix I), our audit results demonstrate that more could have been done leading up to the Abbott powdered infant formula recall."
RECOMMENDATIONS
"We recommend that the Food and Drug Administration:
prioritize maintaining the NCCC’s continuity of operations by cross-training staff on whistleblower policies and procedures and NCCC duties, including monitoring the Occupational Safety and Health Administration whistleblower email inbox;
develop and implement policies and procedures requiring periodic reporting (e.g., monthly reporting) to senior leadership on the status of open whistleblower complaints;
implement policies and procedures that facilitate reporting consumer complaints in real time to investigators onsite when an active inspection is occurring at the facility identified in the complaint;
strengthen the QFC process to identify data entry inaccuracies;
formalize written policies and procedures that either:
require that the CAERS coordinator forward all reports that originate in CAERS to the NCCC or
identify specific factors that the CAERS coordinator must consider when determining if adverse event reports should be forwarded to the NCCC, and include specific examples of types of adverse event reports that do not need to be forwarded to the NCCC;
develop policies and procedures that FDA can use during future public health emergencies to identify how and when it is necessary to conduct mission-critical inspections and ensure that mission-critical inspections are conducted in a timely manner;
design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority;
amend the language on the CAERS adverse event report form to emphasize the importance of including the lot number to encourage the public to report this information; and
continue to seek legislative authority to require infant formula manufacturers to notify and provide the bacterial isolate to FDA every time a product sample is found to be positive for Cronobacter or Salmonella, even if the affected lots have not been distributed, and update its existing databases with the information received."
Let's Take A Closer Look At This Crisis
Below is an overview of the Infant Formula Shortage Crisis. I wrote this following the FDA Oversight Hearing in April 2024 a.k.a. my summarized version of events.
The Infant Formula Shortage Crisis
Hands down, the 'best' part and line of questioning when it came to the infant formula shortage during the 4/11/24 Hearing was by Michigan Representative, Mrs. Lisa McClain
The quick focus on this topic said more than enough- Representative McClain came in prepared, and quite frankly, Dr. Califf appears that he did not.. Congresswoman McClain begins by establishing the timeline of when Dr. Califf rejoined the FDA and the infant formula shortage crisis. It is important to note that Dr. Califf took his position as Deputy Commissioner in Feb 2022.
It is also fair to know, Dr. Califf was Deputy Commissioner of Medical Devices and Tobacco Products from February 2015-February 2016, and then Head Deputy Commissioner of the FDA in February 2016-January 2017. It's important to know this because of that empathy train! I KNOW Dr. Califf did not rejoin at an easy moment, and there is always a learning curve when starting a job, whether entirely new or after some time away.... that being said, given that Dr. Califf had previously held the exact position he was placed in makes my empathy dwindle quickly. Why were delays in response so prolonged and poor?
In fact, Dr. Califf has been asked this question a few times over the last two years.. In May 2022, Dr. Califf was questioned by Rep. Morgan Griffith, R-Va., the ranking member on the committee, "why it took the FDA more than three months to address this shortage. Why didn't the FDA "move heaven and earth" to address this", he asked.
FDA's timeliness in interviewing a whistleblower and getting into the Abbott facility for inspections were "too slow," Califf said. "Some decisions in retrospect could have been more optimal." (May 2022)
To many questions from lawmakers on the agency's work flow and timeliness, Califf simply said, "We don't have a great answer."
Seems like that hasn't changed too much in the last 2 years...
Dr. Califf's FDA testimony from May 2022 reveals how long it took agency to respond. Califf's testimony revealed the FDA first had concerns about a baby formula shortage in March 2020, as the coronavirus pandemic choked global supply chains. "The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to," Califf said.
The FDA learned on Sept. 20, 2021, of a child that had been diagnosed with a cronobacter infection, which can be fatal in infants. The cronobacter bacteria that causes it has been detected in baby formula, with this particular incident focusing on Abbott Nutrition products. FDA inspectors conducted a routine inspection at the formula plant from 9/20/21-9/24/21, ultimately finding the facility in a "clean and sanitary condition."
Well, thats at least what mainstream media and the FDA / Abbott Nutrition want you to believe...
Reality? FDA Inspection reports back to February 2021 show some major concerns and problems, including standing water, cracks in equipment, They even note some findings such as: a box fan blowing towards the Drying Area that had extensive debris and dust built up, personnel working directly with infant formula and its raw materials were not properly washing hands nor utilize basic food safety protocols such as changing out gloves appropriately, sanitizing areas, etc.
Whistleblower reports come October 20, 2021. The whistleblower was not truly interviewed until late December 2021. On December 6, 2021, FDA initiated inspectional planning for a for-cause inspection at the Sturgis facility with an anticipated inspection date in early January 2022. We notified Abbott Nutrition of the planned inspection on December 30, 2021. Abbott Nutrition responded by notifying FDA of approximately a dozen COVID-19-positive employees in its facility. Although FDA delayed inspection temporarily because of these COVID-19 infections, FDA commenced our inspection on January 31, 2022.
These findings were even worse than September..2021.. The January report directly starts by saying: "You did not establish a system of process controls designed to ensure infant formula safety. It was also noted that the sample batch of formula on 2/1/22-2/2/22 did test positive for Cronobacter. The narrative then became, 'the strains of bacteria do not match.'
A "for cause" inspection was not conducted at the Sturgis, MI plant until Jan. 31, more than four months after the whistleblower reached out to the FDA. By then, three infants had been confirmed to have a Cronobacter infection. Two babies were hospitalized and one had died. The FDA became aware of the fourth infant on February 17, 2022.
If you are curious and want to check out that September 2021 report yourself, here it is!
Want to check out the January 31-March Inspection Report? Click below!
When President Joe Biden was questioned by reporters on May 13,2022 (...seriously? May 13??) about whether his administration should have anticipated the baby formula shortage or reacted in a quicker manner, his answer was pretty astounding.. and right in tune with this entire scenario...
"I don't think anyone anticipated the impact of the shutdown of the Abbott facility. Once we learned of the extent of it, we kicked everything into high gear. And I think we are on our way to be able to completely solve the problem.." (said in May 2022....)
During this conference, reporters had heard directly from CEOs of major formula companies, many of whom spoke of their concerns and earlier warnings, months prior to this conference. When a reporter asked, "didn't the CEOs just say that they knew it would have a very big impact?"
President Biden: "They did, but I didn't."
As he goes on to explain that the formula shortage mainly became a problem once Abbott's Sturgis facility was closed, "So, you're saying that they should have anticipated that it would be shuttered?"
.. Yeah, it kinda seems like the warning signs were pretty clear here..
According to President Biden, he became aware of how intense the situation was in early April 2022.
"If we’d been better mind readers, I guess we could have, but we moved as quickly as the problem became apparent to us," he said. "And we have to move with caution as well as speed, because we got to make sure what we’re getting is, in fact, first-rate product. That’s why the FDA has to go through the process."
"The FDA didn't have to read minds...they just had to read their own data," she said. Rep. Cathy McMorris Rodgers, R-Washington,
In an NPR interview with Tamara Keith, who had been keeping an eye on the situation as it was unfolding, this was acknowledged, showing just how prevalent the situation already was before many addressed the topic,
KEITH: "Yeah. This is not a new crisis. It goes way back to February, when a major Abbott factory in Michigan had to be shut down over safety concerns. The FDA is working with that company, but the factory is still closed."
And it seems that Mr. Califf was not too concerned about the scenario by that point in time. "Our data indicates that in stock rates in retail stores are stabilizing but we continue to work around the clock to further increase availability," Califf said on Twitter. (May 2022)
Another Key Piece they all got wrong- How long will the baby formula shortage last?
"The baby formula shortage will drag on at least another month, according to testimony May 2022. Abbott, the largest producer of formula in the U.S., will start production at the Sturgis plant during the first week of June, according to Abbott Senior Vice President Christopher Calamari. It will take 6 to 8 weeks before products are on the shelves, he said. "We know we let you down, and we're going to do everything we can to re-earn your trust," Calamari said.
Fun fact... The shortage is still going on in many ways... in June 2024 (see my last 2 Blog Post for those details!)
**I'm including this because it was some of my favorite questionings during the April 2024 Oversight Hearing & says enough!*
Okay, so what about Congresswoman McClain?
Well, she brought so many of these issues and concerns back into the light!! + exposed just how little has actually changed... & Dr. Califf seemed to have even worse answers for these questions than he did before..
As Michigan rep, Lisa McClain began her questioning, she asked some pretty straightforward questions.
"When taking office, were you aware that an infant formula manufacturer that makes over 40% of the infant formula was voluntarily recalling all of the baby formula it made at it's Sturgis plant?"
Dr. Califf: "I was well aware, it happened on the day I was confirmed." *quickly adds in, "but I didn't know before"
In the days and weeks after assuming office, were you aware there was an infant formula shortage across the country?
Dr. Califf: "well in the first days and weeks, there wasn't a shortage,." (inaccurate)
"But as the shortage evolved, I was very much aware."
Congresswoman McClain shares a few additional stats on out of stock rates, followed by:
"I'd like to enter into the record, 2 internal email exchanges, the first dated February 4, 2022, in which FDA officials are discussing the POTENTIAL of a infant formula supply issues and asking for support from the White House and media support in helping to educate the public. shortage. The second, dated February 19, 2022, in which FDA officials are discussing supply issues that were ALREADY happening. Now, despite these discussions within the FDA, media and the President were not aware of the problem. Even though it was headlining locally across the nation for 3 months. So my question, did the FDA not raise concerns, even before the recall?"
Dr. Califf starts talking about a task force?
Congresswoman McClain: "So it was elevated?"
Dr. Califf: "Well, to the task force"
McClain: "Did the FDA raise concerns about a potential shortage before the recall? Yes or No?"
Dr. Califf: "I can't speak to before the recall just about the time of the recall."
McClain: "Okay, let me help you! The FDA did in fact raise concerns with 9 White House Officials and President Biden took no action. I'd like to enter into record, an email between the FDA and White House Staff. This email dated from February 17, 2022, the day of the recall, shows in fact that the White House was in communication with the FDA. I'd like to enter ANOTHER email into the record, dated February 20, 2022, showing the FDA raising concerns. My question, Why did it take President Biden so long to act?"
Dr. Califf: "I can't speak for President Biden about the particular decision. I don't have the specific emails you are referring to, but this evolved over time, so the exact timing of when the DPA should have been brought in is a matter of discussion."
McClain: "A matter of discussion?? That's your answer? Your FDA office is in contact with the 9 White House Staffers and it's a matter of discussion? Either the FDA didn't tell them or the White House didn't act, which is it??:
Dr. Califf: "I think you have the emails, I can't really comment beyond"
McClain: "You know what baffles me? You make about $200K, you're supposed to be in charge, but when the you know what hits the fan, you all run for the hills I'm going to change topics.."
Dr. Califf: "Now hold on a moment"
McClain: "It's my time, sir. When asking about the handling of this is just unbelievable. You dont have an answer, I'd love to have an answer..."
Dr. Califf: "Well, you're overestimating my salary there."
McClain: "it's~$191,000, close enough.
Dr. Califf: "haha, not even that."
McClain: changes topic
In the final closing remarks, Congressman Jamie Raskin commented on the need for all to work together to understand what truly happened in the infant formula shortage and how the blame should not be placed solely on the FDA. Mr. Raskin sent shockwaves to me personally, as he commented that "Democrats never received all the documents promised by Abbott Nutrition"
Check out my recent Instagram Reel on this topic!
A Few Final, Personal Thoughts after over 2 years...
These are the comments and responses from the FDA in relation to this investigation. While I am extremely happy and proud of the progress made, yet again, it feels like full accountability falls just short..
FDA COMMENTS
"In written comments on our draft report, FDA concurred with our recommendations and findings that FDA: (1) had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes; and (2) did not have the authority to require individuals and manufacturers to provide information that may have helped FDA to identify and respond to risks to the infant formula supply. FDA stated that it strongly agrees that adequate policies, procedures, and authorities are needed, and that delays due to poor procedures are unacceptable and must be corrected. FDA indicated its commitment to implementing the Office of Inspector General’s (OIG’s) recommendations for strengthening its program and has begun several steps to improve policies and procedures for complaints, recalls, and infant formula inspections. FDA also stated that it will continue to pursue additional authority as OIG recommends. Examples of actions
FDA described it has taken and plans to take to address our recommendations include the following:
The Food and Drug Administration's Infant Formula Inspection and Recall Process (A-01-22-01502) 22
For whistleblower complaints, FDA stated that its CFSAN’s Office of Compliance has developed a process to track, evaluate, follow up, and notify compliance leadership of regulatory misconduct complaints, which includes whistleblower complaints.
For all infant formula-related events, including whistleblower complaints, FDA stated that CFSAN has developed a leadership notification memorandum, which lays out which infant formula-related events will be elevated to the highest levels of FDA leadership, who in FDA leadership will receive the
notifications, which office will be responsible for sending the notifications, and generally what information will be contained within a notification.
For consumer complaints, FDA stated that it is working on longer term IT improvements that will make its currently manual process a systematic one for compiling and sharing compliant data across FDA to help inspection preparation. In addition, FDA’s ORA and CFSAN components have created elevation distribution lists, SOPs, and mechanisms for emerging public health issues to be shared across FDA centers.
For continuing to seek legislative authority, FDA indicated that in its FY 2024 budget request it formally requested the authority to require infant formula manufacturers to notify FDA of any product that tests positive for pathogen contamination, regardless of the disposition of that product."
Alright alright, looking pretty good!..... but then.....
"In addition, FDA noted in its comments that the report contains some statements that do not align with the available evidence. Specifically, FDA stated that the report presents findings and conclusions that at least four reported illnesses, including two deaths, may have been preventable. FDA states that these statements are predicated on a possible causal link between the Abbott facility and the reported cases, which was not substantiated by evidence from the investigation. Lacking evidence of causation, FDA is not aware of other sufficient or appropriate evidence to support postulation. At a minimum, FDA believes that these findings and conclusions about illness prevention are incomplete and potentially misleading unless revised to clarify that evidence from the investigation does not substantiate a causal link between the Abbott facility and the reported cases."
SOOOO close....
And while I don't want to scare others from using formula or anything of the sort... the only way we can actually make improvements... is if we acknowledge the truth. Believe as you would like, but the PR campaign is long over. Parents just want proof of improvements, safety, and some true care. This OIG report was definitely a good win though! The facts and timeline are on record like never before.
It can't all be hidden forever...
Especially if we want to do better.
Full OIG Report Here:
OIG Report Landing Page:
*I'll just leave these additional takeaways from April here too... cause they say enough...
Some other really astonishing Key Takeaways & Topics / issues addressed during the FDA Congressional Oversight Hearing (April 2024):
Limited Ownership across Departments
Essentially 0 progress noted to the Closer To Zero movement...
Medication labeling with allergens
Medication Shortages, Generic Medications, and the Orange Book
Illegal vapes, in many ways worsened by slow action of approval of safer options by FDA, tobacco policies
Misinformation
Reproduction and Medications
Many vague answers across the board.. and I think approx. 7+ Congress members called out Dr. Califf regarding his lack of email correspondences and responses
Want to check out the Hearing from April 2024 for yourself and learn more about these topics + the other endeavors at the FDA?! Click Here:
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Jessica Enderle, R.D., L.D.
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