The Hill: 1,860 unconstitutional FDA rules

April 29, 2019 | By TODD GAZIANO

This article was originally published by The Hill on April 29, 2019.

Will the Food and Drug Administration (FDA) change its rule-making practices when it learns that 98 percent of its regulations since 2001 were unconstitutional? That’s the figure we uncovered in a comprehensive study examining 2,952 Health and Human Services (HHS) regulations issued during a 17-year period.

If a federal agency enforces even one invalid rule against Americans, it breaches the public trust and the rule of law. Enforcing 100 invalid rules would constitute an unprecedented threat to democratic principles from a lawless agency. What we found at FDA dwarfs those figures. From early 2001 to early 2018, FDA issued 1,860 unconstitutional rules.

Though we didn’t know the full scale of the problem, we broke the news of FDA’s unconstitutional rule-making practices a year ago with our lawsuit challenging the FDA’s “deeming rule.” That regulation made vaping product retailers subject to the same requirements as cigarette manufacturers under the Tobacco Control Act. We explained that the deeming rule was not just bad policy, it also was illegal: a career civil-service employee named Leslie Kux signed and issued that rule, even though she had no constitutional authority to do so.

Because Kux was never nominated by the president, confirmed by the Senate, nor hired by the HHS secretary pursuant to a congressional authorization, she could not be an “officer of the United States” as the Constitution defines that term. Career employees such as Kux (who worked at the FDA for 30 years) fill vital staff roles in federal agencies, but they are not democratically accountable for significant policy decisions. Kux’s exercise of rule-making power — the power to issue final regulations that are binding on citizens — was an impermissible end-run around the Constitution’s Appointments Clause, which allows only officers to exercise such coercive governmental power.

The deeming rule litigation is ongoing. Tellingly, the FDA demonstrated its fear that the rule is in jeopardy this month by seeking to cure the constitutional problem with a letter from FDA Commissioner Scott Gottlieb two days before he left office, purporting to “ratify” the rule Kux illegally issued three years ago. The FDA still refuses to acknowledge its past violations of law; Gottlieb denied there was any problem to cure in his litigation-induced letter, but his unusual action speaks louder than his denial. What’s worse, FDA has not altered its unconstitutional practice of career employee rule-making.

We were curious just how common that practice is. In the study released today, Pacific Legal Foundation looked at every rule issued by HHS agencies from Jan. 20, 2001, through the first year of the Trump administration. Among this database of 2,952 rules, we found that 71 percent were unconstitutional, the great majority of which were issued by career staff.

The primary culprit at HHS is FDA. Since 98 percent of FDA rules were unconstitutional (all of those were issued by career employees), and FDA issues so many rules, FDA’s illegal practices skew HHS totals. For FDA rules, the signature of the Senate-confirmed FDA commissioner or HHS secretary is the rare exception. Instead of taking responsibility for the vast majority of FDA rules, the constitutional officers left final rule-making decisions to what some have dubbed “the deep state.”

The study by Angela Erickson and one of us also determined that the employee-issued rules at FDA were not just insignificant ones — 25 unconstitutional FDA rules during the study period each had economic impacts of $100 million or more. Besides the deeming rule, the unconstitutional FDA rules include a counterproductive rule governing skim milk labels, an important (and beneficial) rule regarding the approval of generic drugs, and many more.

Interestingly, other components of HHS have not shown the same disregard for the Constitution, or at least not at the same level. For example, 75 percent of the Center for Medicare and Medicaid Services’ rules were issued by a Senate-confirmed officer, and most were countersigned by the HHS secretary. An even higher percentage of CMS’s substantive rules were constitutionally issued.

Overall, only 2 percent of HHS’s substantive unconstitutional rules were issued by agencies outside the FDA. Compliance with the Constitution clearly is not too much to ask, and it does not bring the process of issuing important regulations to a halt. Instead, it ensures that Senate-confirmed officers are accountable for — and make the final decision regarding — rules that bind the public, as the people who ratified the Constitution insisted.

How could such a blatant violation of the Constitution go unnoticed for so long? An FDA commissioner in 1991 didn’t want the responsibility or distraction that issuing rules imposed and delegated that task to FDA career staff. Once the bureaucracy took over, no one ever thought hard enough about whether that was constitutional. In a similar vein, the Supreme Court ruled last year in Lucia v. S.E.C. that the Securities and Exchange Commission (SEC) had been violating the Appointments Clause for decades in selecting its administrative law judges.

Ignorance or negligence is how such failures start, but stubbornness and imperious attitudes keep them going. At FDA, Leslie Kux and her career employee successor keep issuing rules, putting new regulations in continued legal jeopardy.

Like the SEC violation, the problem we uncovered at HHS will not go away if left to the career staff illegally wielding power. The longer agencies allow rule-making to continue deep within the bureaucracy, the more rules (good and bad) are jeopardized. Other lawsuits surely will follow ours, yet responsible elected officials should not wait for courts to force action. After all, employee rule-making is not merely a legal problem. Regardless of its constitutionality, it’s a monumental lapse in democratic accountability.

Agency heads should act promptly to ensure that future rules are signed by Senate-confirmed officers. Congress should assert its prerogative to prohibit delegations of rule-making power from Senate-confirmed officers to employees. And President Trump, with a stroke of his pen, could order that all rules issued in his administration are signed by Senate-confirmed officers.

The current administration committed to reducing the regulatory burden, and numerous members of Congress from both parties share this goal. For these reform-minded leaders, ending the unconstitutional practice of employee rule-making should be a top priority.

Todd Gaziano is the director of Pacific Legal Foundation’s Center for the Separation of Powers. Follow him on Twitter @ToddGaziano.

Thomas Berry is co-author of PLF’s HHS rule-making study; both are counsel for vaping retailers challenging the FDA deeming rule’s legality. Follow Berry on Twitter @Thomas_A_Berry.