FDA Matters Blog
Every Monday, FDA Matters subscribers receive “Q&A Monday.” They may recirculate, quote from, or reprint it, etc., at their own discretion, which can be particularly useful for media. I do not publicly post the column until the following Monday. You can find past columns on the Q&A Monday tab (here).
If you would like to receive Q&A Monday columns every week “when-issued,” please subscribe on the site or email me at sgrossman@fdamatters.com. Here are two recent Q&A Monday columns:
Q&A - September 22, 2025 Read More
Is there something that received less attention but particularly concerns you? (Yes, termination of the Household Food Security survey)
Will there be a government shutdown? What are the likely impacts for FDA if there is one?
Q&A - September 8, 2025 Read More
Is Secretary Kennedy at risk of losing his job?
What is Kenvue? Doesn’t J&J make Tylenol?
How realistic is it to dramatically shorten product review cycles?
I have experienced numerous shutdowns and shutdown threats. Sadly, they have become a familiar part of my DC life. Most often, there is a last-minute deal--whether a 48-hour Continuing Resolution (CR), a week-long CR, or a 6-week CR. No one expects a last-minute deal to happen this time….
Regardless of what is being said, Congress feels the pressure and the sense of failure that accompanies a shutdown….
Today (September 30), every affected federal employee was given notice of their status for tomorrow (October 1). As a practical matter, there will be three categories…
The FDA is at a crossroads — with numerous initiatives, several threats, and constant tension between its statutory responsibilities and a White House and HHS leadership that views science as highly manipulable for their own ends.
Our nation’s health, well-being, and economy depend on a successful FDA (All of Us Need to be Rooting for FDA). However, that does not give the Commissioner carte blanche to define success solely by his own vision....nor does it absolve the stakeholder community from a responsibility to speak out constructively about the state of the agency and how it could better perform its duties.
As an advocate for a more effective, efficient, and fair FDA, I have compiled a roundup of some of the most concerning FDA issues as of September 26, 2025.
Based on my personal experience, dating back more than 40 years and spanning the administrations of 12 prior HHS secretaries, I can say that Robert F. Kennedy, Jr. stands alone in the breadth of his ambition to remake public health, vaccine policy, and the American diet. By itself, that might be laudable.
However, Kennedy's approach is uniquely his own. He declared his singular vision; then imposed it as an article of faith to which all must adhere. He has backed this by firing, marginalizing, or exiling seemingly everyone with the expertise or impudence to disagree….
While trying to reshape public policy, each of Kennedy's predecessors would have sought sources of expertise….
To many of us, advisory committee meetings are emblematic of an FDA that listens, is open to diverse viewpoints, and is willing to change direction when other views prove compelling.
FDA never yields the authority to decide. Yet, agency decisions about higher-profile new drugs often feel more complete when they incorporate an advisory committee's review of the data.
The reality of advisory committees may often fall short of their promise. Still, the symbolism never loses its power to remind us that the FDA is committed to serving the American people fairly, dispassionately, and in accordance with science.
My positive view of advisory committees may not be shared by Commissioner Makary. By actions-- more than words—he has given the impression that he does not value the advisory committee system.
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
This week:
My Comment on Secretary Kennedy’s September 4 Appearance Before the Senate Finance Committee
MAHA Strategy Plan Likely to Be Released Week of September 8.
MAHA vs. MAGA: Much Ado About the Usual Interest Group Politics?
HIMS vs. Novo Nordisk Advertising: What I Saw While Watching College Football
What I Am Listening To: FDA Watch Podcast with Wayne Pines and Paul Kim
For much of the past 20 years, my primary professional responsibility has been to impress upon lawmakers, the media, and stakeholders that FDA’s value far exceeds its budget.
Sometimes, I would emphasize the economics…
At other times, I would emphasize the history….
Sometimes, I would emphasize the complexity of the FDA’s mission….
At other times, I would emphasize the global reach and responsibilities of the agency…..
Regardless of my approach, I would always emphasize that FDA’s dedicated and diligent staff are the key to the agency’s success in managing this incredible breadth, depth, and complexity of responsibilities.
With that perspective, I appreciate Dr. Makary’s efforts to build up staff and find more efficient ways to fulfill the agency’s responsibilities…..Even still, I am troubled by how many FDA initiatives start with conclusions rather than questions…..
The Make America Healthy Again (MAHA) movement has sparked an overdue examination of how to improve the health of Americans, particularly in terms of safe food and healthy diets. Unfortunately, this effort has devolved into an acrimonious debate among competing interests and ideologies. The rancor is likely to escalate further once the MAHA Commission Action Plan is released by the Administration sometime later this month or in September.
Before the heat builds further, FDA Matters would like to remind all parties of the primary goal and most urgent need: a plan for all Americans to have access to a healthy and affordable diet.
When I launched FDA Matters on January 10th of this year, I started with some topics to analyze, but no sense of which subjects represented my advocacy priorities. That turned out to be a good thing--since the new Administration brought so many new issues to the fore, ones that would not have been on my list at the start of 2025.
Nearly fifty columns later, I see that patterns have emerged--certain topics on which I have dug deeper and spoken more forcefully. While there is room for additions to the list, here are my top six priorities at this time:
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
This week:
August in DC—No Longer Slow
The Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft
Former FDA Commissioner David Kessler Submits Citizen’s Petition Calling for Action on Ultra-Processed Foods (UPF)
Every day, we are failing patients with chronic progressive neurological, neuromuscular, and genetic diseases.
The brouhaha about Sarepta and Elevidys is just a reminder that we are not systematically addressing the common plight of these patients: 1/ their disease is progressive and they cannot wait for safer and more effective treatments to be developed and approved, 2/ they are willing to take on a lot more “safety risk” and “efficacy uncertainty” for even the slightest chance of a benefit, and 3/ they are dealing with complex heterogenous diseases that, regardless of patient population size, will make drug discovery and development difficult….