Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA
Earlier this week, I posted an “FDA-Related Thought of the Day.” According to LinkedIn, it has generated an astounding 29,796 impressions (and counting!). That’s a lot more interest than it garnered when I first posted it a month ago (here). Here is what I said (slightly edited):
Understaffed regulatory agencies (i.e., FDA) will tend to say “no” more often because they do not have the staff, time, or focus needed to reach “a nuanced yes.”
Think of the breakthroughs at FDA; think about how much extra time and experienced and well-trained staff were required.
The LinkedIn posting drew a brilliant question (thank you Christy): “Would that still be the case [less capacity for a nuanced “yes”] if an administration has a goal of cutting regulatory burden while also taking savings from cutting staff?”
Here is how I replied (again, slightly edited):
In most cases, the opposite of regulation is not "no regulation" or “deregulation”....it is "less burdensome regulation." You want food to be safe--you can decide some current steps are unnecessary, but history tells us that going to "no regulation" does not deliver a safe food supply. Caveat emptor is rightfully associated with a notoriously unsafe food supply and “anything goes” patent medicines.
Deciding that three checkpoint steps assures safety just as well as five checkpoint steps is important in lessening regulation. However, if it really is "as good," then most of the savings will be on the industry side (two fewer checkpoints), not at FDA where they still need to assure the outcome, such as “a safe food supply.”
"Chesterton's Fence" is metaphor for why you cut regulations carefully: Do not tear down a fence until you know why it was put up to begin with.
That leads to two other points:
1/ you do not cut employees today on the promise of cutting regulatory burden sometime in the future.
2/ government is not a business. But no business would do a large RIF without a plan in place to assure the downsized entity can function. In the DOGE-led downsizing, there is no plan--the RIFs were random and arbitrary.
“Deregulation” and “eliminating regulations” are universally extolled and make great campaign slogans. However, they are just that: slogans.
Rather, “less burdensome regulation” or “lessen the regulatory burden” seem like appropriate goals to me. That allows us to encourage re-evaluation and change in the regulatory environment…while minimizing bad outcomes and not carrying forward the biased assumption that less regulation is always better.
Yesterday, the Administration ordered government-wide wholesale repeal of regulations. To facilitate this, they suspended the requirement for “notice and comment rulemaking” under the Administrative Procedures Act. “Notice and comment rulemaking” is the bedrock of government transparency.
Politico was not impressed. https://www.politico.com/news/2025/04/10/federal-agencies-public-notice-comment-trump-administration-00284499. Nor am I. It reinforces my view that “eliminating regulations” is most-often a slogan rather than a mindful exercise.
Response to Possible/Proposed Massive Reorganization of FDA. The Center for Science in the Public Interest (President Peter Lurie/Director of Regulatory Affairs Sarah Sorscher) posted an insightful critique of the reorganization proposal being circulated by the administration (here).
I reposted it on LinkedIn and added the following thoughts:
“A massive reorganization of FDA—changing functions, philosophy, and process--will endanger consumers and patients, create chaos for industry, and dramatically reduce FDA productivity for months. Therefore, it follows: even if the proposed reorganization of FDA is brilliant (and we can certainly disagree about that), the unknown long-term benefits of such change (5 years?) is unlikely to exceed the extremely high and far more certain short-time costs (2-3 years). Count me as a fan of well-planned incremental changes.”
In turn, the article by the Center for Science in the Public Interest and my comment were reposted by former Commissioner Califf, who observed:
“Hard to tell what is really being planned vs what is being "floated". Transparency would be helpful.”
Response to FDA Commissioner Makary’s Decision to Permit Some Reviewers to Work from Home. Mathew Perrone of Associated Press (AP) reported the story here.
The story quotes me about first steps for Dr. Makary and how “work at home” fits in:
"Dr. Makary needs to rebuild teams and restart the engine of productivity lost to weeks of job insecurity, uncertainty and shortages of team members,” said Steven Grossman, a former HHS official. “Turning commuting time back into work time is a great first step in achieving both.”