How we treat kids after they're born

Guns now #1 cause of childhood mortality. Meanwhile, parents scramble after FDA fails to police infant formula makers

May 26, 2022

A letter in last week’s New England Journal of Medicine showed firearms surpassed car accidents as the leading cause of death among children and adolescents in 2020.

No wonder. This week’s cold-blooded massacre of 19 young children and two teachers in Uvalde, Texas, coming just 10 days after the racist murder of 10 African Americans in Buffalo, was the 27th school shooting in the United States this year, and we’re only in May.

Meanwhile, the blame game escalates on who’s responsible for the infant formula shortage. The proximate cause is Abbott Laboratories failure to maintain sanitary conditions at its Sturgis, Mich., plant. After a whistleblower informed federal officials about horrific conditions inside the factory last October, it took four months before the Food and Drug Administration shut down a factory responsible for about 16% of all infant formula sold in the U.S.

While the two events that have dominated domestic news this week appear to be entirely separate issues, there is a common problem at their roots. The anti-regulation movement that has been a dominant force in American politics for over 40 years has defanged every government agency charged with protecting public health and safety, whether its preventing racist or deranged 18-year-olds from obtaining automatic weapons or stopping profit-obsessed corporate officials from ignoring basic food safety protocols in their manufacturing plants.

I wrote here about the failure to control guns after the Buffalo mass murders; and here about unregulated political hate speech played a role, which in other contexts is considered a crime against humanity. Today, I’ll simply call attention to how the Republican Party and the National Rifle Association have stymied action on banning assault weapons and instituting tougher background checks, which the overwhelming majority of Americans favor.

Dan Froomkin’s Press Watch today points out how “It’s the Republicans who have turned guns into a political issue.” Meanwhile, Claire Potter chimes in on how Republican Blood Money has prevented change.

Meanwhile, in my own city of Chicago, which garners a disproportionate share of headlines about gun violence, a new report in the Chicago Sun-Times shows the Bureau of Alcohol, Tobacco and Firearms routinely metes out mild penalties to the dozen or so stores across the Indiana line that are responsible for the lion’s share of illegal guns flooding onto Chicago streets. The report found ATF routinely issues mild slaps on the wrist to stores selling guns to straw buyers, transferring guns without background checks and doctoring records.

Why the ‘F’ in FDA is silent

There’s a laundry list of regulatory failures that created the situation where young parents today are scrambling to find formula to feed their hungry children. Modern Healthcare reported this afternoon desperate parents are showing up at pediatric wards and hospital emergency rooms hoping to find formula for young children with special nutritional needs.

The failures start with the food division at the FDA, which Congress over many years has systematically starved of the funds necessary to carry out its mission of protecting the food supply. Staffers there do not have modern tools like computerized data collection systems or sophisticated labs, which are necessary to rapidly identify adulterated products or foodborne bacteria.

At an House Energy & Commerce Oversight subcommittee hearing on Wednesday, FDA commissioner Robert Califf even blamed mailroom delays for the agency’s failure to respond more rapidly to the whistleblower’s complaint. “We have a very tired, overworked workforce and an underfunded agency,” Califf testified. “We’re seeing people laboring to do things that could easily be done by computers.”

Moreover, the FDA lacks the power to rapidly crack down on safety violators. FDA officials had to wait for Justice Department officials to negotiate a consent agreement with Abbott before it could step in to deal with the situation.

But even now, with emergency supplies of formula being flown in on military planes from Europe and other manufacturers stepping up production after President Biden invoked the Defense Production Act, it will be months before the infant formula supply chain is back to normal. Abbott senior vice president Christopher J. Calamari, head of the company’s U.S. nutrition division, testified the company won’t have the plant up and running again until mid-June. It will take another month before that production reaches supermarket shelves.

So what’s happening in the meantime? Families with young children are being victimized by price gougers. Internet scammers are taking advantage of unpoliced internet platforms like Amazon and Ebay to peddle infant formula at rates as much as 300% more than pre-shortage prices.

Yet the Federal Trade Commission prior to this week never said a word about the price-gouging, just like it failed over many years to use its antitrust enforcement powers to regulate an industry where three major manufacturers (Abbott, Gerber and Perigo) control 80% of the market. On Tuesday of this week, the FTC finally launched investigations into both industry concentration and price-gouging.

Earlier this week, I attended a conference where Scott Gottlieb, FDA commissioner during the Trump administration, suggested the supply chain problems in the infant formula industry were similar to those plaguing the generic drug industry. When a business that requires a fairly high level of technical and manufacturing expertise becomes very low margin, the number of producers willing to remain in the market declines to just a handful — the ones that can eke out profits by being high-volume producers.

The downside is that it leaves that industry, whether infant formula or generic drugs, vulnerable to any type of supply chain disruption, such as the shutdown of a single plant in Sturgis.

It’s a great theory if you accept the gospel as preached in Economics 101 textbooks. But Abbott’s most recent annual filing with the Securities and Exchange Commission tells a different story.

Abbott earned an operating profit of $1.76 billion on $8.29 billion in sales of its nutritional products in 2021, a profit margin of 21.2%. That ranks infant formula just below pharmaceuticals, medical devices and information technology software in terms of overall industry profitability. Abbott CEO Robert B. Ford took home a tidy $22 million in salary, bonus and stock options last year for that performance.

Republicans questioning Abbott and other industry executives on Wednesday apologized for having to ask tough questions. Rep. Fred Upton (R-MI), whose district includes the Sturgis plant, seemed more interested in getting Califf to “walk the plant” with him when it reopened in June.

Absolutely, Califf replied. “This is your district. The fact you will be there is a critical part of this effort.”

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