FDA Matters Blog
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?