Q&A - July 11, 2025

Dear FDA Matters subscribers–—Second edition of Q&A Friday, a new feature for subscribers. Each “Q&A Friday” will go to subscribers first, then posted on the website a week later. It is on the record, so subscribers (including reporters) can use and circulate the Q&A immediately upon receipt.

Subscribers are encouraged to submit questions about any aspect of FDA’s mission, responsibilities, programs, and policies--to: sgrossman@fdamatters.com.  I will try to respond to questions in a way that makes all of us a little smarter about the agency.

Steven

Postings this week:

·       If you were away the week of July 4: All of Us Need to Be Rooting For FDA

·       July 8: FDA in a Post-Reconciliation World

·      LinkedIn exchanges on compounding: Pharmacist view and Health Canada

·      LinkedIn exchanges on food safety and consumer protection after reconciliation: here and here.

Q&A FRIDAY

I am using this week’s Q&A Friday to ask myself some questions about topics and positions that were covered in the forty columns since our launch on January 10, 2025. This should be especially useful for the many subscribers who have signed up recently.

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Q: What is the farthest reaching, most consequential idea that you have advanced in FDA Matters?

A: I would offer up this observation from The Skeptical Enthusiast’s Guide to AI at FDA:  

“When the Clinton administration downsized the federal government in the 1990’s, some of the success of that effort was attributable to embracing new technology. The Internet was gaining traction and there was the opportunity to create efficiencies in government around that then-new technology. A similar opportunity exists today for AI to play a role in making the US government more efficient.”

Then, as now, there is resistance to technological transformation based on fear, uncertainty, and lack of appreciation of the profound and positive changes that are possible. That there is precedent for technological transformation in government should make it easier to accept.

I applaud Commissioner Makary for understanding this opportunity and moving forward enthusiastically......whereas I sense a lot of lip-service from many other government officials.

Then, as now, we need to appreciate that we are working with a technology whose capabilities, strengths and weaknesses are formative, not set. There is an almost irresistible impulse to oversell how far along we are.

We are in the top of the 1st inning or bottom of the 2nd inning in a nine-inning game of AI development and adoption. I would love to see an FDA  plan that recognizes we are in the early phases and articulates next and future actions to achieve full integration of AI at FDA.

Q: What concept has been the most useful in explaining FDA during H1/2025?

A: I became a big fan of Chesterton’s Fence (Chesterton’s Fence and the Meaning of Deregulation and Other Thoughts About FDA). The concept is “don’t take down a fence until you know why it was built in the first place.” The goal is to promote thoughtfulness; not to suppress change.

It popped up a number of times this spring as a way to underscore what was wrong with arbitrary RIF’s and the decimation of many government functions that seemed essential.

In some cases, people were later recalled but it is hard to see how “random returns” beats “prospective planning.” For example, if a major theme of the new Administration is combatting chronic diseases, then why wipe out the CDC National Center for Chronic Disease Prevention and Health Promotion?[1] Similarly, if your goal is to improve nutrition and eliminate certain types of food additives, then laying off top employees in FDA’s Human Foods Program and forcing out Dr. Kevin Hall, NIH’s lead nutrition researcher,[2] looks more like self-sabotage than a plan to achieve success.

As described in the first question, the Reinventing Government effort led to a substantial downsizing in the federal work force over a period of several years. However, it followed Chesterton’s Fence....starting with what government should do and how each department and office contributed to those goals.

Q:  A subscriber asked: your June 30 column, “All of Us Need to Be Rooting for FDA” (here) is an interesting take. Are you hearing a lot of stakeholders rooting for FDA failure?

A: I have not heard anyone actively rooting for FDA failure. However, there is a lot of unhappiness and doom-prophesizing that sometimes feels unrestrained and unconditional rather than measured and constructive. Often, it is heedless of the context in which Commissioner Makary must operate. Sometimes it feels like agency failure is the desired outcome....without any apparent self-awareness of how destructive that would be.

 No one in government should get a free pass--as FDA Matters columns will continue to demonstrate. I would add: we need continued dialogue among all stakeholders and the FDA that reflects that an effective, efficient, and fair FDA is a universal goal.

[1] The proposed merger into the Agency for a Healthy America is neither a good nor bad idea so much as one that will be less effective, less efficient, and could fail unless Chesterton’s Fence is applied. Useful background: https://www.statnews.com/2025/06/04/cdc-chronic-disease-center-folded-into-new-uncertain-home-administration-healthy-america/ [2] He was asked back later--after the error was pointed out--but he was not convinced that his work could be advanced without bias. https://www.statnews.com/2025/05/16/nih-kevin-hall-ultraprocessed-foods-nutrition-censorship/

Have a great weekend,

Steven