The elliptical billiard balls of FDA policy

Chevron deference has, in essence, rigged the game for FDA. Now more than ever, the agency needs modernized, defensible policies

Judges shouldn’t try to adjudicate science and legislators shouldn’t try to legislate it. Nobody is more troubled by this than FDA Commissioner Robert Califf. The good news is that he and the agency he leads are part of the solution. The bad news is that they are a big part of the problem.

Ad hoc decision-making and a lack of regulatory reproducibility and predictability makes the already high-risk proposition of navigating the FDA process wildly frustrating. Decisions that contradict the agency’s own policies sew confusion and drive away investment in new medical technologies. The solution to ambiguity is not hiding behind the Chevron doctrine — the legal precedent that instructs judges to defer to the expertise of regulatory agencies. FDA must lead by taking a much more proactive and nimble approach to regulatory science. The agency’s ability to keep pace with and, indeed, incentivize scientific innovation will become even more vital if Chevron is scaled back or struck down — a very real possibility.

“I’m very worried about that right now,” Califf said during a recent podcast. “Judges are obviously not scientists and not trained to adjudicate clinical outcome data or biomarker data to make these kinds of decisions. So, usually, it’s only a matter of if the FDA violated a procedure. It’s sort of a technical issue.”

Well, “technical” is in the eyes of the beholder — and “procedures” are technical by nature and design. Importantly, procedures are not always entirely the bailiwick of scientists — regulatory or otherwise. Legislators write rules and regulations all the time. Judges decide when those mandates, measures and statutes are bent, broken or ignored, and what remediation, restitution or punishment fits the breach, infraction or violation.

No government agency has the authority to decide which regulations to follow — especially their own. “Do as I say, not as I do” is bad policy. Regulatory ambiguity does not instill faith in the process. Nowhere is this more true or timely than within Commissioner Califf’s White Oak aerie.

You don’t need a weatherman to know which way the wind blows. That the “Chevron Doctrine” is under attack should come as no surprise.

In 1974, the U.S. Supreme Court stated that deference depends on an administrative interpretation being consistent with the agency’s other statements and being consistent with the congressional purpose. In 1984, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), the Supreme Court set forth the legal test for determining whether to grant deference to a government agency’s interpretation of a statute which it administers.

This decision articulated a doctrine now known as “Chevron deference.” The doctrine consists of a two-part test applied by the court, when appropriate, that is highly deferential to government agencies: first, whether Congress has spoken directly to the precise issue at question, and second, “whether the agency’s answer is based on a permissible construction of the statute.”

Chevron is one of the most important decisions in U.S. administrative law and has been cited in thousands of cases. But the past is prologue and it’s time to ask two questions, is Chevron deference dead and should it be?

In an age of advanced cellular, tissue, and gene therapies, with new science requiring more finessed regulatory science, process, and procedures, “pre-emptive” authority is not the same as arbitrary decision-making. Without getting into a philosophical argument over the benevolent power of the “Administrative State,” it’s certainly worthwhile to have a frank conversation about what should or should not be “protected” when a science-based agency such as the FDA makes decisions that run afoul of their own rules, regulations, and guidances (both draft and final). Ad hoc agency actions and decisions aren’t always wrong – but they do generally lead to confusion. That’s not good for regulated industries, healthcare professionals, payers, investors, or (most importantly), patients and caregivers.

Such instances should result in revising agency protocols rather than hiding behind the apron strings of Chevron deference. All too frequently, they don’t.

Any discussion of “science-based” decision-making needs to start with the caveat that science (and certainly regulatory science) evolves and that the proper route for evolving regulatory standards and practices is debate, discussion and public comment. So-called “podium policy” is not appropriate, nor is the FDA’s most potent tools of delay and avoidance. Regulatory policy is too important to be debated “On a cloth untrue / With a twisted cue / And elliptical billiard balls.”

It is time for the FDA to move on from delay and avoidance, to creating systems for regulatory science that can pull FDA’s procedures and guidance into the modern era, updating them much more frequently, leaving fewer opportunities for contradictory regulatory actions. A good first step would be to cease and desist from the age-old agency practice wherein its leaders give high-profile public speeches that begin with, “These remarks are my own opinions not those of the agency” and then proceed to outline radical (or reactionary) policy pronouncements that are widely reported and have enormous real-world impact.

Rather than arguing that Chevron deference is an unconstitutional limit on judicial oversight, let’s all agree that the FDA must be a leader in regulatory science and, when seeking the protection of Chevron deference, the explanation for agency actions needs to be more than “because we said so.” That’s not a viable, reliable, or reproducible standard. Whether or not it remains a legally robust argument remains to be seen.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest, a visiting professor at the University of Paris School of Medicine, and a visiting scholar at the New York University School of Medicine, Division of Medical Ethics.

Signed commentaries do not necessarily reflect the view of BioCentury.