At Wednesday’s high profile Congressional oversight hearing on the nation’s baby formula supply crisis Rep. Frank Pallone, 70, chair of the Committee on Energy and Commerce wasn’t looking to make headlines.
He was looking for baby formula.
In the process he discovered that formula wasn’t the only vital product that our “real time delivery” profit driven system had left in catastrophic short supply. As it turns out, letting corporations run the world has resulted in scarcity for something called contrast material, a fluid that is injected intravenously to help physicians flag clots in the heart and brains. Of course, it’s being rationed now because the U.S. is reliant on China for it which in the midst of yet another COVID lockdown.
And then there’s the severe shortage of generic medicines in our hospitals Pallone was told.
Pallone left it to his House colleagues to use their questioning to find out why it took the FDA four months to inspect Abbott Nutrition’s troubled infant formula plant in Michigan after a former employee warned about it in a detailed 32-page complaint filed back in October. In that interim of inaction by the agency two infants died and several were hospitalized.
As he made clear in his opening remarks, it wasn’t that the 17-term House veteran was not outraged by the FDA failures that had the nation’s parents caught in a 21st century hunger games to feed their formula reliant infants.
“The impact from just one infant formula plant closing in the United States shows the power one single manufacturer has to influence the nation’s supply of formula when just three companies control roughly 95 percent of the market,” said Pallone. “We are too reliant on too few companies to do the right thing—and when just one of those companies cuts corners, we spiral into an emergency.”
And as Pallone noted, the misery inflicted on the public was compounded because it was low-income women and children reliant on the federal government’s WIC program that were hardest hit by a shortage that actually started back in late 2021 due to pandemic-related strains on the supply chain that were made catastrophic by the Abbott plant February product recall and plant shutdown.
It was in Pallone’s questioning of FDA Commissioner Dr. Robert Califf and Abbott Vice President Christopher J. Calamari that the longtime member of the House’s Progressive Caucus displayed his results oriented pragmatism. (Other New Jersey members include Rep. Donald Norcross, Rep. Bonnie Watson Coleman, and Rep. Andy Kim.)
“This has got to be like a General in the field,” Pallone told Califf. “The President has invoked the Defense Production Act, launched operation Fly Formula. You are taking actions with Abbott. How is this going to complement each other? Will it be effective in getting this formula out quickly—your talking two weeks—three weeks to get this shortage over with and then as part of that how will you get information distributed so that we can tell our constituents how they get this formula—how they can have access to it so they can get it? Two minutes.”
“First of all, you say this is a war mentality. It is a crisis,” conceded Califf. “We are fully aware of it. Families should not be searching for formula but they have to do it for now until we fill in. Several weeks out we will have a surplus of formula. When I say several, I can’t say exactly how many weeks. Until then we have to fill it in with all these measures. The other producers have stepped up. We are now importing. We are flying military planes and other planes to pick it up and bring it in and we just have to just keep filling it in until we get to the point where production is up. The good news from Abbott….”
Pallone grounded the Biden political appointee mid-sentence as the FDA Commissioner was preparing to take off into the corporate spin zone.
“How about getting it out so our constituents know how to get the formula?” Pallone interjected. “I am very concerned that you do all this and they won’t know how to access it and still have a problem, particularly low income people that don’t have access to information easily.”
Califf took another swing at giving Pallone an answer to a basic question. Yet that response sounded equally devoid of any real sense of urgency because it continued to place the burden back on the public who he insisted were being capably served by supply chain “professionals” all evidence to the contrary.
“Yes, I think it’s really important for people to go to the HHS website. There you will find the hotline for all the manufacturers and helpful information about where to go,” said Califf. “The distribution is being handled by really professionals in supply chain who have been working throughout the pandemic with a variety of products. So, as soon as it comes in we will get it to the places that are in greatest need. But you are right the public is going to have to stay attuned hopefully through that website to get the information that they need.”
Leaning in, Pallone urged Califf to “think of other ways too—let’s think of other ways to get that information out as this formula becomes available hopefully in the next couple of weeks.”
Pallone pressed Califf for ways Congress could intervene to ensure the FDA wasn’t “bogged down” in a bureaucratic response when lives were at stake.
AS IF LIFE MATTERED
“I am concerned about a future crisis because we need to have a mechanism in my opinion where the manufacturers tell us— or there is some kind of trigger or alarm bell at the FDA if they are experiencing shortages for whatever reason,” Pallone suggested. “So, what I am told is maybe we need to have some kind of transparency legislation through shortage reporting requirements that require manufacturers to alert the FDA of potential shortages so they can shift production or we can go into overload and also something to empower the FDA to act more quickly with regards to contamination because that process is so bogged down and long and cumbersome…[In] a minute and a half. What can we do to have better reporting so that you don’t get bogged down in this long process when there is potential contamination—or any other tools you think you need.”
Califf explained that his agency had requested Congress grant it enhanced “authorities to deal specifically with the potential for infant formula shortages” but their efforts were successfully resisted by industry, who it should be noted often employ former government regulators, members of Congress and their staffers.
“We did a number of things at the FDA to deal with it with the resources we cobbled together,” explained Califf. “And you mentioned a couple of things that are absolutely critical. Right now, we have no ability—there’s no requirement that manufacturers alert us if they are running short.”
And incredibly, the FDA head told the House panel, Abbott was under no legal obligation to report the presence at its Michigan plant of Cronobacter sakazakii, which can cause an opportunistic infection in infants, that can result in poor feeding, irritability, temperature changes, jaundice, grunting, and abnormal body movements that requires immediate medical care.
“Abbott had cultured Cronobacter in samples going back a ways but since they had not shipped them out they had no requirement to either keep the samples or alert us that it happened,” Califf said. “We just discovered it on inspection but it may surprise people to know that.”