Alexa Beichler, a mother of three boys under five in Leesburg, VA, is among the many “faces” of the national infant formula shortage.

Two of her boys have classic phenylketonuria (PKU), in which they cannot process an amino acid found in protein. This means they require – for life -- the very formula Abbott Labs was making in Sturgis, MI, the plant the U.S. Food and Drug Administration (FDA) shut down leading to the current crisis.

According to Beichler, the Biden administration’s "Operation Fly Formula" did not have the right kind of formula for her sons' needs.

Fox reported: “Beichler spoke to Virginia Rep. Jennifer Wexton (D-10th District) about the problem but wasn’t given a solution.”

"If she can’t get any answers, and I can’t get any answers, then who has the answers?"

Well, the answers to how this started are within the FDA and its inconsistency in infant formula inspections.

This whole ordeal began last fall when FDA audited Abbott Labs’ Sturgis plant and issued a 483 -- essentially, a list of violations that require “official action.”

Then, an unnamed whistleblower -- believed to be a former employee -- talked to the agency, around the same time four infants became ill with Cronobacter sakazakii, and two died.

So, the agency collected samples from the babies and had them tested by the Centers for Disease Control and Prevention.  FDA also collected milk samples from Sturgis.  Although the strains in the infants were different, and not found in the milk, according to Abbott, the agency swooped into Sturgis in early January with 12 auditors, quite a large number.

This inspection team found more “objectionable conditions,” including Cronobacter, and ordered the plant shut. The agency for the second time in months issued Abbott a 483, which is a form listing violations of Good Manufacturing Practice (GMP) rules.  Abbott initiated a recall of the lots that could be affected.  The agency Feb. 19 issued a warning to parents to not use the products from these lots -- Similac, Alimentum, and EleCare powdered formulas    

According to a report by House Commerce Committee Oversight and Investigations Subcommittee, “none of the five strains found in environmental samples matched the two patient samples that CDC analyzed.” FDA’s own labs showed no Cronobacter in the Abbott samples either

But in testimony to the panel, FDA commissioner Robert Califf, M.D., said “we cannot confirm the formula caused the illness or death or rule it out.” 

Califf was never asked about how the agency treated other infant formula makers.  But records I obtained some years ago for Food & Drug Inspection Monitor, a trade newsletter of the Washington Information Source, a publishing firm I owned from 1991-2021, show that competitor Mead Johnson’s (MJ) facility in Evansville, IN, was inspected in January and February 2012, after FDA gave the facility a clean bill of health based on testing samples of Cronobacter.

According to FDA’s Establishment Inspection Reports (EIR), which are more detailed than the 483, this audit was spurred by 91 reports of infants having a series of adverse reactions to the company’s Enfamil formula, produced in powdered form.

Like the Abbott situation, the Mead Johnson audit was triggered by consumer complaints involving “infants who tested positive for Cronobacter Spp,” according to the EIR, which listed only six FDAers in the plant vs. 12 for Abbott this year. Four infants became ill and two died after consuming the MJ formula.

MJ’s previous audit in 2011 was classified voluntary action indicated, unlike Abbott, which had 483s issued in two previous audits in 2019 and 2021.  Due to COVID FDA did not inspect many facilities in 2020, although they generally audit infant formula plants each year. 

However, the findings from both inspections are similar, yet MJ had no 483, no massive recall, and no plant shutdown.

In fact, according to the article in Food Navigator, the agency gave MJ a clean bill of health before the Evansville inspection even occurred -- involving eight auditors, not 12. I have covered FDA since 1986, and it is rare FDA sends 12 auditors to a facility. 

Additionally, Mead’s Indiana plant was audited in 2017.  In this case, the firm got a 483 -- which means objectionable violations.  They included the “presence of Cronobacter SPP. in critical and high hygiene areas of the processing environment on 26 occasions between 1/23/17 and 08/28/2017.”  The 483 also cited similar problems found in the Abbott plant. Ironically, the House subcommittee had these documents before the hearing but did not ask FDA about them.

In my view, FDA came down harder on Abbott vs. Mead Johnson because the Sturgis plant garnered 483s in 2019 and the fall of 2021.  Two of the 12 FDA staff that swarmed the Abbott Sturgis plant in January, investigator Daniel Arrecis and national food expert Elizabeth Mayer, were the leads on the 2019 and 2021 audits.   

Plus, the agency received a “whistleblower” complaint last fall, which may have played in FDA’s fears that the Sturgis plant was out of control and needed to be closed.

By May 8, according to the O&I panel report, some 43 percent of infant formula SKUs were sold out at major retailers across the nation.  The Sturgis plant supplied about 35% of the U.S. market, Abbott testified.  In essence, FDA created a worse problem than what it tried to solve due to regulatory tunnel vision.

The Abbott EleCare shortage has been the most problematic, especially for parents like the Beichlers.  Abbott reported that it will be the first product to go into production after the Sturgis plant goes on line this week.

The firm added: “While Abbott has limited inventory of these products, there should be enough to fulfill current patient needs until new product is available in the coming months.”

It’s possible FDA went lighter on Mead in 2012 because the agency was under fire at that time for causing a number of drug shortages due to GMP compliance actions, which led to the enactment of the FDA Safety and Innovation Act that fall.  This law requires the agency to report to Congress each year on drug shortages -- but not shortages of other products.  Members of Congress are looking to change that.

For its part, in my view, Abbott rolled over and played dead too easily.  I have no idea if its attorneys and regulatory staff advised FDA compliance personnel of an acute shortage if they shut the plant, or complained about how lightly Mead was treated. 

The firm also agreed to a “Consent Decree” prior to the May 18 hearing, which compels it to meet certain FDA requirements.  Consent decrees are almost always done for serious GMP violations and violations of federal law.  In my view, this doesn’t meet that threshold, but big pharma firms like Abbott generally do not fight the agency in court -- they go ahead and comply so as not to imperil how the agency views its other products in review.

Now, the HHS Inspector General is  investigating  “Specifically, we will review FDA's actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott's initiation of the infant formula recall.”

But will the I.G. examine inspection consistency between how Mead was handled vs. Abbott?  Will the I.G. bother to ask why FDA did not rely on testing of the milk before issuing the “do not use” order on Feb. 19 and ordering the plant shut?  Did FDA staff consider shortages when they acted, or not? 

I emailed FDA spokesperson Jennifer Dooren with questions about why FDA treated Mead Johnson more lightly but brought the hammer down on Abbott.  She did not respond

Ken Reid covered FDA from 1986 to 2021, mostly as editor and publisher of Washington Information Source Co. –www.FDAINFO.com – which ceased publication in December.

Image: Abbott Labs