Short Takes and Updates -- July 25, 2025
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
This week:
Familiarity Breeds Respect
Imminent Danger Regarding Food Priorities
New CDER Leadership
Re-Exploring Reconciliation Cuts’ Impact on FDA Consumer Protection Responsibilities
About FDA Matters
There are an overwhelming number of policy and regulatory issues facing the agency and the stakeholder community this week. Here are a few that deserve consideration.
Familiarity Breeds Respect. Getting to know people is often a pathway to overcoming prejudice about them.
Prior to coming on board to lead the agency, Commissioner Makary was outspoken in his criticisms of the agency and its staff. Michael McCaughan of Pink Sheet/Regulatory sees a different trend emerging: effusive praise for FDA staff by Dr. Makary and admiration for their ability to handle large and difficult workloads (the article is here).
Dr. Makary’s embrace of the FDA workforce gives us hope that he will be their advocate... and will more fully engage them in public meetings and other areas where staff expertise has always been an FDA hallmark.
Imminent Danger that Food Ingredients Will Upstage Food Safety. Given Secretary Kennedy’s and Commissioner Makary’s focus on chronic disease in children and their emphasis on developing healthier eating options, it is no surprise that food ingredients have received a lot of attention. We can all argue about the merits of specific recommendations, but the ongoing discussion and scrutiny is almost certainly a good thing.
That said, I would argue that the safety of our food supply is and should remain FDA’s number one food priority. More emphasis on a safe food supply doesn’t preclude a deep dive into ingredients...we can do both. If one were to go by what is being written and said--it sure feels like the importance of a safe food supply is no longer a priority. I cannot overstate how serious the consequences would be if that turned out to be true.
New CDER leadership Fits in the Mold of the Commissioner. I told the press this week that:
“What is most notable about Dr. Tidmarsh's appointment to head CDER....is how much he is like Commissioner Makary and Dr. Prasad, the new head of CBER."
That is, they are all intellectually elite, extremely articulate, deeply tied to academic medicine, and steeped in clinical trial design topics and questions of epistemology.
Additionally, they are all out-spoken, critical of the so-called scientific establishment, and relish the role of iconoclast. CDER is much larger than CBER and requires more management experience, something Dr. Tidmarsh provides as well."
The FDA announcement of Dr. Tidmarsh’s appointment is here.
Re-Exploring How Cuts to Health Insurance and Feeding Programs Will Result in Increased Consumer Fraud in Health Products and Foods. My recent article, FDA In a Post-Reconciliation World, seems to have been understood generally as an interesting and concerning consequence of reconciliation cuts.
Based on feedback I received, I realize many of my readers have no sense of how and why food and medical products are a sweet spot for consumer fraud. I have been using the example of melamine adulteration of milk products, a worldwide crisis in 2008 that caused many deaths and altogether affected about 300,000 children.[1] The motivation was crystal clear: when tested, melamine (which is inexpensive) mimics protein whey (which is the most expensive component of milk products).
This example helped, but I am seeking more ways to illustrate the dangers from a weakened FDA role in consumer protection. It is unthinkable that we could return to the days of patent medicines and foods that are routinely adulterated. BUT that is possible...so I will be writing more on the topic and would love examples that make this risk more concrete.
A Little More About FDA Matters for those reading it for the first time:
FDA Matters doesn't cover the news....we provide analysis of what's behind the news.
If you are not reading FDA Matters blog (www.fdamatters.com), then you are missing a valuable resource. The columns appear 1-2x/week and are 3-5 minutes reads. Sign up (free) on the website (www.fdamatters.com) or send me a note at sgrossman@fdamatters.com and ask to be added to the subscriber list.
As a subscriber, new issues will arrive in you inbox when published, rather than meander haphazardly into your social media feed. Also, we have added a subscriber-only feature called “Q&A Friday.” A sample of some past Q&A columns is at: https://www.fdamatters.com/friday-qa. We are considering other subscriber-only benefits.