Get the ‘F’ out of the FDA

The COVID-19 pandemic is changing the way Americans think about public health. There’s little doubt that government officials, corporations and citizens need to do a much better job of working together — and some regulatory agencies are clearly getting in the way. As our Mercatus Center colleague, the noted economist Tyler Cowen, bluntly (but fairly) put it, “Our regulatory state is failing us.” 

When it comes to the U.S. Food and Drug Administration (FDA), the failure is so dramatic that it might be time for the agency to be dismantled, at least partially. 

The FDA has been particularly problematic during the COVID-19 pandemic. The frustrations are well known at this point: Its regulations and inflexible procedures have prevented businesses and entrepreneurs from stepping in and providing critical supplies like hand sanitizer and facemasks. Its highly restrictive virus testing processes have been a major barrier to the creation of new COVID-19 tests that could help detect outbreaks and save lives. In the words of Dr. Alex Greninger, “This virus is faster than the F.D.A.” 

So, why has the FDA failed so dramatically at a time when success is quite literally the difference between life and death?

Perhaps it’s just too big — not necessarily in terms of budget, but in terms of bureaucracy. When organizations grow, they rely more on strict rules and procedures. Over time, this causes them to become less and less flexible and adaptable.

The problem is compounded by the fact that the FDA is charged with regulating both food and drugs, two drastically different things. 

Although it’s generally true that regulatory agencies are risk averse, the aversion differs from one agency to the next. Just as in the private sector, each organization has a culture that can shape its actions in a powerful way. Some agencies adopt a “precautionary principle” mindset and assume new products and services should be halted until proven useful and safe. The idea is that we should require innovators to get permission before innovating, in order to protect the public and give regulators the first say in the process.

Other agencies adopt a framework more akin to “permissionless innovation.” Here, innovative efforts are presumed innocent until proven guilty, and the burden is placed on the regulator to show why and how government should tap the brakes and interfere. 

The FDA’s mixed mission, which includes assessing risks for food and for drugs and medical supplies, is not necessarily a good mix for one organization. Consumers need safe food and pharmaceuticals, but that doesn’t mean their risk tolerance should be the same for each. 

Consider someone who eats organic food to minimize his health risks. There is little-to-no evidence that organic food is any safer than other food, but he’s willing to pay a premium for the possibility of extra safety. He probably prefers that his food regulators have a precautionary bias as well. 

On the other hand, consider an individual with potentially terminal cancer. She is probably willing to try an experimental drug with even the smallest chance of success, even if there is some risk that it’s ineffective or even unsafe. She’s willing to trade some precaution for the potential of innovation.

To make matters more convoluted, there’s another federal agency that regulates food safety: The U.S. Department of Agriculture. In fact, FDA and USDA food safety regulations sometimes mix in bizarre ways. Take your favorite slice of pizza. If it happens to be pepperoni, it is regulated by the USDA and will go through its inspection process. But if it is a cheese pizza, it is regulated by the FDA. 

Why not take the best and most essential food safety responsibilities away from the FDA and consolidate them with the USDA? Food safety experts can assess which regulations are needed from each agency, which ones are counterproductive, and how they should fit together. Meanwhile, removing the food portion of the FDA would allow the agency to clarify its mission and better focus on drugs. 

We can argue about whether the food safety authority should go to the USDA, a new agency, a private third-party certification body, or whether some of it should be phased away entirely. As long as we can get the “F” out of the FDA. 

Patrick McLaughlin is a senior research fellow and Trace Mitchell is a research associate with the Mercatus Center at George Mason University.