FDA Matters Blog

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).