New Study Finds FDA in Contempt of the U.S. Constitution

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A recent study conducted by the Pacific Legal Foundation examined 2,952 regulations issued from 2001 until 2017 by the Department of Health and Human Services. The study found that 2,094 of these regulations (about 75 percent) were unconstitutional. Many of these rules negatively impacted small businesses and individuals’ well-being.

The HHS’s unconstitutional, excessive, and harmful rulemaking were nearly entirely driven by its largest agency, the Food and Drug Administration. Over the same period, 98 percent of the regulations enacted by the FDA (totaling 1,860) were found unconditional. Twenty-five of these rules had an economic impact of at least $100 million.

Perhaps even more worrisome is what makes these regulations unconstitutional (and illegal). The Constitution requires that regulations enacted by federal agencies such as the FDA or their umbrella departments such as the HHS come from principal officers. Typically, these officers are appointed by the President after Senate confirmation.

However, the vast majority of these regulations were passed by “low-level officials and employees with no authority to issue rules.” Legally, these regulations cannot be backed by the rule of law. As Thomas Berry, one of the study’s co-authors, notes, “Only properly appointed officers in the executive branch may issue regulations that are binding on the public. This preserves democratic accountability for significant executive branch actions.”

But the frequency of FDA’s issuance of fines and product-recall mandates strongly suggests the Constitution has little authority to restrict the agency’s “evolving regulatory powers.” Unfortunately, these powers have been evolving since at least the 1930s. Regularly allowing those with no legal authority to issue regulations is one of many examples.

So what can be done to hold these regulators accountable? Although difficult, the answer is to reduce their power. Luckily, pressure from the Trump administration to deregulate has shown some success in reducing the FDA’s enforcement actions. Right-to-try legislation reduces the agency’s authority to restrict access to potentially life-saving but unapproved treatments for patients with terminal illnesses. Other efforts to deregulate are also underway.

The findings in the Pacific Legal Foundation’s study are alarming but predictable. Government power, including its influence over the healthcare field, increases rapidly when it is left unchecked. The FDA’s rapid and illegal regulatory expansion is just one example. Let’s hope studies like these and others motivate the public to push back and discipline the FDA. It’s certainly overdue.