The FDA Is Not a Referee

148

Last October, the Food and Drug Administration began surveying ground cinnamon products. By November, the agency identified elevated levels of lead and chromium in applesauce pouches across several producers. Suspecting the worst, the FDA mandated recalls and began investigating whether lead was intentionally added to these products. 

By December 2023, the FDA amassed 65 reports of adverse effects linked to recalled products. In February 2024, it had received 400 reports of adverse effects. Between then and now, the FDA was able to trace the contamination to a single cinnamon producer in Ecuador. 

However, it has still struggled to prevent further illness or find a way to address the issue. Lead poisonings from contaminated and recalled apple sauce products now exceed 500. And, as one NBC News article highlights, the FDA has only begun to scratch the surface to determine how this contamination happened.  

How can the same organization that helped create a devastating national infant formula shortage just two years ago now be completely unable to get poisoned applesauce off US shelves? 

Hoping for a quick fix, FDA Commissioner Robert Califf urged Congress to intervene and pass a law requiring private companies to test their products for lead (they already do). 

Congress usually doesn’t need much motivation to write another law. But the Commissioner’s request confused many of our representatives. As Congressman Jamie Raskin asked during a House Committee of Oversight and Accountability meeting, “What keeps you [the FDA] from inspecting every private manufacturing facility that produces things like cinnamon applesauce or peanut butter?”

In response, Commissioner Califf likened the FDA’s role in these matters to that of a referee: “You all in Congress actually write the rulebook, much like in any sport. It’s the leadership [Congress] that writes the books; we enact what’s in the book.” 

This is not the first time he’s used the referee metaphor. While speaking at the 2023 Food and Drug Law Institute’s annual conference, Commissioner Califf remarked:

In many ways, we are like referees at the FDA—we don’t make the products, and we adjudicate by a set of rules that are codified in laws, rules, and guidance.  Of course, we have an influence on interpretation of the rule book through guidance and we provide technical assistance as Congress writes the laws.  Much like good referees in sports, we cheer on a competitor who makes a great product and plays by the rules and we have an obligation to penalize poor play and dishonest avoidance of the rules.

At first glance, the comparison seems sensible. Upon further review, it should be overturned. While the FDA enforces rules, it decides how and when to enforce them. 

For example, no Congressional statutes set safety and efficacy standards for prescription drugs and medical devices. The FDA sets these standards. When potentially life-changing or life-saving medications are not allowed on the market because they fail to meet the 99 percent statistical significance threshold, the FDA decides which producer is following the rule and what the rule is. 

Imagine a referee deciding if a wide receiver kept his feet in bounds while catching a touchdown and determining where the endzone is. That’s what the FDA does. 

Letting referees enforce and decide the rules is not only confusing, but it also creates conflicts of interest that others can exploit for personal gain. Such situations are the exception for professional referees; they are the rule for the FDA.

US Drug producers have a longstanding “revolving door” of hiring former FDA employees (including Commissioners) to give them an advantage in advancing through the agency’s approval process. A close relationship between drug producers and the FDA also allegedly influences which drugs reach the market. I’ve yet to hear of a professional sports team hiring a former referee to help them receive fewer penalties.

As a health economist and sports fan, I don’t see many similarities between the FDA and referees. But if they have one thing in common, we should be skeptical that either will make the right call when it matters most.