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! 

Elon Musk thought cutting government programs was about deficit reduction. When the “One Big Beautiful Bill” reconciliation legislation passed the House with a $3 trillion price tag, he realized he had been misled and reacted accordingly.

I welcome Commissioner Makary’s embrace of AI and applaud yesterday’s announcement of the next step in agency adoption of AI technology. 

I wrote earlier that: “AI can help FDA make better regulatory decisions based on more refined and accurate information…

“While discretionary spending is not part of the reconciliation process, some policymakers may point to savings from that category as “offsets” for other policies.”

FDA makes significant contributions to public health, public safety, scientific and technological innovation, US investment, and the flow of commerce—producing a positive return-on-investment that far exceeds its budget. Yet, owing largely to our nation’s ongoing and precarious fiscal situation, it gets harder each year to convince the Administration and Congress to provide FDA with robust funding.  

Today, May 22, 2025, is the last day that mass compounded GLP-1 obesity medicines can be sold. Yet, some companies intend to continue selling compounded GLP-1 drugs to a large number of their customers by gratuitously adding other ingredients or making similar modest and unnecessary change…then saying it is being compounded for the special medical needs of a specific patient. The hypocrisy is clear: a special medical need is not a mass need. 

The most important questions facing FDA and the stakeholder community are: 

After the lay-offs, RIFs, and voluntary departures, does the FDA have enough staff and expertise to fulfill the agency’s responsibilities?

If there are tasks and obligations that will not be met--or not met in a specified timeframe--will the agency address statutory, Congressional, and stakeholder concerns? 

“Flooding the zone” has worked as a strategy for the Trump Administration, at least so far. We are all so busy reacting to the newest proposals that we don’t have time to address the previous week’s initiatives from the Administration.

While I can’t seem to get ahead, I usually have a good sense of what is coming next or, at least, the range of possibilities. That’s an important aspect of both my FDA Matters writing and my client work.

I am tired of the continued defamation of FDA as an agency controlled by industry. 

That is not to say that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, as a generalization….no, FDA is not controlled by industry. 

Such allegations are usually based on ignorance or a genuine misunderstanding of how FDA works. Sometimes it is hard to tell, as with recent statements that advisory committees: decide drug approvals…

The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story. 

Reactions ranged from “Omigod, he’ll destroy the industry and the hope of patients” to “no big deal, staff do the product reviews regardless of who runs the Center.” Experience tells me his tenure is likely to be a little bit of both….but mostly other things that have to do with leading CBER during a time of great promise for products within its jurisdiction. 

After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and called the truth.

Several decades ago, when I was a Senate staffer, I observed that I could spend the entire Gross Domestic Product on the good ideas that people brought to us. I soon learned that lawmaking requires a substantial amount of restraint and a lot of prioritizing. Those are hard virtues to develop and very hard to keep when you face voters every few years. 

FDA’s responsibilities have not changed since January 20th. However, its capacity to carry out its duties has been meaningfully reduced by the Administration’s downsizing. We should all be able to agree on that.