Short Takes and Updates—February 14, 2025
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1. When Will Congress Engage on the Future of FDA User Fees?
Either the agency is captured by industry (Secretary Kennedy), or it is a hindrance to industry (Vivek Ramaswamy). I understand how it could be neither…but not how it can be both.
The lack of clarity is of concern to nervous corporate executives and many FDA employees. I have pointed out that PDUFA VII and MDUFA V and GDUFA III do not expire until September 30, 2027, with initial discussions only just starting this summer. There is time for this discussion after the new Administration has been in office for a while and taken care of more pressing issues.
I am starting to feel a bit nervous about this answer. So far, the new Administration has shown little patience for waiting on anything. If they feel strongly, they seem to want to engage immediately….contractual agreements and statutes not necessarily representing barriers.
This is not a prediction, just a lessening of my certainty that user fees are off the table until later.
2. More on FDA and Reconciliation.
My primer on FDA and reconciliation (here) was widely read and should have an extended shelf life. The point of my primer is that the deep budget cuts from reconciliation (adopted by authorizing committees) will create an appropriations funding environment that puts FDA (and NIH, etc.) at risk.
The tie between reconciliation and appropriations was reinforced at yesterday’s House Budget Committee mark-up, where cost-cutting targets were increased to accommodate the House Freedom Caucus (here). HFC members are eager for deep cuts in appropriated funding.
A couple of readers asked: is FDA also vulnerable to cuts in funding through the reconciliation process itself? Under the House reconciliation bill adopted in the Budget Committee yesterday, House Energy and Commerce Committee was directed to generate a minimum of $880 billion over ten years. At that scale, the primary target will be Medicaid.
To achieve savings from FDA, House E&C would have to adopt statutory language that had a budget impact on the agency. This seems unlikely but not out of the question.
3. What We Are Reading: Reversing Misinformation by Michael Miller, MD.
Inspired by Teddy Roosevelt’s comment that “complaining about a problem without offering a solution is called whining,” health policy analyst, Michael Miller decided that confronting rampant medical misinformation deserved a practical guide for individual action.
More about the book and about “Dr. Mike” can be found here.
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