‍Since the founding of our republic, there has been debate about states’ rights vs federal rights. And in times of stress, the discussion gets more heated and gains more traction. Once again, FDA is moving into the center of such debates.

‍National uniformity is central to FDA’s mission and responsibilities.‍ In general, food and drug regulation is based on the need for--and value of--comprehensive nationwide coverage of regulated goods and services…

In addition, consumers benefit from the protection offered by one federal agency. Access to safe food and drugs should not vary depending on where a person lives….‍ ‍

FDA appears to be on the brink of fresh engagement where states’ rights and preemption will be central issues….

The announcement that former CBER Director, Dr. Peter Marks, was joining Lilly as SVP for molecule discovery and head of infectious diseases....set the internet ablaze with unjustified outrage about his transition from a government career to industry. My multiple comments and responses on LinkedIn (e.g. here) received nearly 20,000 impressions in total.

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Below are questions from FDA Matters subscribers (www.fdamatters.com). Follow the link to read the full discussion.

Q: Peter Marks would have had many attractive post-FDA opportunities besides pharma. Why choose the one he did? [partial answer]

A: ....His passion — and his most significant contribution to society — has been his commitment to the well-being of patients and his role in facilitating the development of safer and more effective therapies, especially for those with rare diseases. If he cannot be doing that at FDA, what better place than at one of the world’s largest drug discovery organizations, with the budget and mandate to make a difference?...

Other reader questions I address are:

Q: Isn’t Dr. Marks working for a drug company an example of industry controlling FDA?

Q: Why do so many FDA employees work in regulated industries after they leave FDA?

Q: Do you expect more stories about FDA staff moving to industry?

Q: Are FDA employees allowed to own stock in companies that they regulate?

Every day, our country is failing patients with relentlessly progressive chronic neurological, neuromuscular, and genetic diseases. Their plight necessitates a significantly different risk-benefit calculation than that of patients with other types of diseases....

This past summer’s brouhaha about Sarepta’s Elevidys for Duchenne’s Muscular Dystrophy is a stark reminder that we have no systematic way of thinking about these patients and the clinical trials they participate in. FDA’s risk-benefit calculations need to be more context-sensitive to accommodate their situation.

Relentlessly progressive chronic diseases require:

• A regulatory framework that reflects the different risk-benefit considerations; and

• Scientifically and statistically-based standards for evaluation.

Without those, FDA will not be able to move past its current situation: unable to appropriately respond to the needs of these patients and failing to encourage the types of research and innovation needed to make regulatory decisions for these diseases easier in the future....

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.

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….

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

A little under half of the FDA’s roughly $7 billion budget is funded by user fees. Tobacco user fees pay for the entire tobacco program, while medical product user fees pay for between 20% and 70% of most medical programs.

Food programs are, effectively, “all taxpayer funding, no user fees.”

“The One Big Beautiful Bill Act” (aka OBBBA) was signed into law on July 4, 2025. The immediate and long-term consequences of this bill are the most important story to write about today. Other topics can wait.

Although the impact of OBBBA on FDA is largely (if not entirely) indirect, there are, nonetheless, consequences for the agency.

Medicaid, SNAP, CHIP, and Affordable Care Act Changes. The OBBBA cuts to feeding and health programs--which are spread over several years--represent a significant challenge to FDA…

There is very little support among stakeholders and FDA employees for the 2025 version of the FDA. Some of us are discouraged. Some of us are trying hard to find the good in agency proposals and actions.

Regardless of where any of us stand, all of us need to be rooting for FDA to be successful. Here’s why…..

Recently Novo Nordisk dropped out of its arrangement with Hims and Hers because the latter continued to sell compounded GLP-1 weight-loss products that are no longer legal (except in extremely limited situations).

As children, we are taught that “sticks and stones will break my bones, but words will never hurt me.” That may have helped children develop resilience against verbal bullying, but it totally discounted the power of words. As adults, we know better. Words matter!