Why is Congress preparing to offer the FDA $28 million, with no explanation for how it addresses the formula crisis?
At best, defenders of the bill justify it as a way to hire needed staff and expedite resolution. At worst, its a reward for incompetence.
As the United States reels in the face of a severe infant formula shortage, Wednesday’s vote from the House of Representatives approved bill H.R.7790, formally referred to as the Infant Formula Supplemental Appropriations Act. Within the text of this single page and simple bill is a straightforward line that reads as follows:
“For an additional amount for “Salaries and Expenses”, $28,000,000… to address the current shortage of FDA-regulated infant formula and certain medical foods in the United States and to prevent future shortages…”
In short, the bill is a $28 million dollar check signed over to the FDA from Congress, the only stipulation being that it go towards “Salaries and Expenses”. But while the bill has all the right language of addressing the crisis at hand, in function, it’s a puzzle as to what this is actually supposed to do to ameliorate that crisis. At best, defenders of the bill justify it as a way to hire needed staff and expedite resolution. At worst, its a reward for incompetence. But before that, here’s a quick timeline of the formula shortage…
March 2020 - Formula sales surge with the COVID-19 lockdowns, and in the months that follow, production starts to dip as parents rely upon stockpiles.
September 2021 - The FDA conducts a routine inspection of Abbott’s formula plant in Sturgis, Michigan, and finds only minor infractions. Abbott is responsible for 42% of formula production in the USA, with the Sturgis plant as a major production site.
October 2021 - A whistleblower sends a letter to the FDA regarding the Abbott facility, warning of unsafe production practices.
December 2021 - The FDA interviews the whistleblower.
January 2022 - The FDA inspects the Abbott plant in Sturgis and finds additional violations.
February 2022 - Abbott issues a voluntary recall and the Sturgis plant is closed.
May 2022 - During a hearing with the press, the Biden administration fields the first questions regarding the formula crisis.
It should be pointed out that the current formula shortage was exacerbated by the Sturgis plant closure, not caused by it. But while it’s difficult to explain the crisis by a singular event, there are identifiable actions from the FDA which have arguably made it worse. And no, being short-staffed does not appear to be one of them.
For starters, the FDA is offering neither defense nor explanation for its actions. Why did it take the FDA two months to follow up with the whistleblower? Why did the government not acknowledge the problem until 7 months after the FDA was alerted about the Sturgis plant? FDA Commissioner Robert Califf offered no answers when pressed during a subcommittee hearing:
“We have an ongoing investigation about the details of exactly what happened, from point A to point B along the way, and since it is ongoing, I can’t give extensively more details on that part of it.”
The oddest part of this hearing was the exchange between Califf and Rosa DeLauro, a representative of Connecticut and chair of House Appropriations Committee. DeLauro grilled Califf, at one point declaring he could not hide behind an investigation and that Congress needed answers now. Califf simply deferred, stating Congress had the timeline and “…we could do better than we did.”
What’s odd about this? The fact that DeLauro is the one who sponsored H.R.7790, which had been passed the day previous to this hearing. Why was this not mentioned? If the FDA was hurting for staff, could Califf not simply have mentioned this during the hearing? But most of all, why did DeLauro sponsor a the bill for the FDA before knowing what the problem was and how much money would have been needed, if any?
Additional criticisms came during the hearing, such as from representative Mark Pocan, stating how in his tenure on the committee (10 years) the FDA had always demonstrated terrible communication. Frankly, the well of incompetence fills the further back you look.
Tariffs as high as 17.5% that have existed for over a decade, making formula imports more expensive from foreign nations.
The FDA made it illegal to import formula brands for Europe, simply because they were labeled in a way that did not meet government expectations, but were acknowledged as being safe.
In their March 2022 budget report request, the FDA requested a 34% increase from the previous fiscal year, coming to a total of $8.4 billion. Absent from this report were any concerns related to formula production or safety, or staff needed to reassure this service.
Finally, the FDA has not found any evidence that warranted the shutdown of the Sturgis plant in the first place. Reports from Abbott, the FDA, and the CDC found strains of Cronobacter sakazakii (the bacteria in question) but none that caused any reported illnesses. This was determined in April, and it was not until mid-May that the plant was given clearance to resume operations.
What exactly is Congress hoping to accomplish by signing off on what seems tantamount to a salary increase for the FDA, despite their gross incompetence? We don’t know.
What is $28 million - 0.4% of the FDA’s current operating budget - supposed to fix in the face of the formula crisis? We don’t know.
Why has the current administration taken so long to address this immediate problem? We don’t know.
For the parents most directly affected, securing the food that their precious newborns require is top priority, but this crisis should be kept in memory. Whatever and whoever was responsible for the shortage’s propagation should be removed or reproofed as the situation requires.
In short, meet incompetence with punishment. Not a bonus check.