Over the course of 17 years, the Food and Drug Administration issued 25 federal rules that each cost Americans potentially $100 million or more.
That’s the alarming finding of research I released this month through the Pacific Legal Foundation cataloging the lack of democratic accountability within the Department of Health and Human Services (HHS) and, in particular, the FDA.
The data tell the story of a system in which career federal employees, who lack the constitutional authority to issue regulations, sign thousands of rules that bind the American people with the force of law. With regulatory rules dwarfing congressional statutes, the number of laws that bind Americans that were instituted without accountability is staggering.
These include numerous regulations that carry a significant economic impact, as well as rules that define how words can and cannot be used, or even restrict Americans’ ability to talk about their own experiences.
The electorate has no influence over the decision-making of these employees. They are not elected by voters, nor do their positions depend on who controls the presidency or Congress. And it’s almost impossible to fire federal employees. That means none of them are accountable to the people.
That’s a problem because, under the Constitution’s Appointments Clause, our democracy requires any individual issuing regulatory law to be appointed by the president after Senate confirmation. This system ensures accountability since it means rulemakers will be responsive to elected officials, who are in turn responsive to the voters.
Among HHS agencies, the FDA is the least accountable to the public when it comes to regulatory decision-making. During the 17-year study period, FDA employees issued 1,860 final rules with no constitutional authority to do so. That means 98 percent of all FDA rules in this period were issued by employees without accountability, rather than Senate-confirmed officials.
These regulations cost Americans billions of dollars every year through higher prices for goods and services, reduced consumer choices, stagnant wages and lost jobs.
But these rules don’t just carry economic costs. They also cost Americans their basic freedoms — like freedom of speech.
For example, the FDA made it costly for Steve Green, who owns a vaping shop in Sonora, California, to earn an honest living. An FDA rule, signed by a career bureaucrat, classified all vaping products under the Tobacco Control Act, including products containing no tobacco or even nicotine.
But it wasn’t just Green’s business that suffered; FDA regulators also targeted his freedom of speech. Steve had quit a 30-year smoking habit and recovered from early signs of emphysema after switching from smoking cigarettes to vaping. But according to a rule written by a federal employee, Steve cannot educate consumers about how he quit smoking without FDA approval — a clear violation of his First Amendment rights.
If a problematic rule were signed by a Senate-confirmed official, senators could easily bring the official in for questioning. And since that official is a presidential appointee, the president would also face scrutiny. If the public disapproved, the voters could sweep the president and all his appointments out of office in the next election.
But there’s no accountability of this kind for bureaucrats who spend their careers in a federal agency, shielded from public scrutiny.
Congress and the president need to fix this system failure. First, President Trump should order that all rules issued in his administration be signed by his Senate-confirmed officials. And Congress should assert that rulemaking power is only held by officials confirmed by the Senate unless they explicitly provide otherwise. Those should be the first steps taken to restore accountability to the regulatory process.
Angela C. Erickson, strategic research director at the Pacific Legal Foundation, is co-author of Who Rules the Rulemakers?
This article was originally published by The Daily Caller on May 9, 2019.