What I Learned By Speaking About “FDA in Trump 2.0”
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On Monday, I had the honor to address the annual meeting of America’s Blood Centers (ABC). It reminded me how much I learn by preparing for speeches and panels[1].
From this current effort, I have three main take-aways to share, each quite different from the other:
Understaffed regulatory agencies (i.e., FDA) will tend to say “no” much more often if they do not have the staff, time, or focus needed to reach a nuanced “yes.” Think of the breakthroughs at FDA; think about how much extra time and staff those have required.
The new and appropriate emphasis on chronic diseases is likely to result in underinvestment in our ability to respond to acute conditions. We need more, not less, attention to emerging infectious diseases, vaccine development, biodefense, and pandemic preparedness.
In a government transition, incoming leaders are likely to think: if it looks easy, then it must be. If you are fortunate to be the advocate for a government program that is going well, expect your success to be unappreciated and your resource needs taken for granted. My advice: prepare a zero-based defense[2] of the federal role in your area and of the resource needs required to assure that the activity is successful and “continues to look easy.”
These thoughts are part of my larger presentation on “FDA in Trump 2.0.” I was asked to respond to the questions:
Given we are still relatively early in a government transition, how is FDA doing in Trump 2.0?
What do we know for sure vs. what might happen, but we can only speculate at this point?
Please be mindful that I took some big swings on the speculation—these are possibilities not predictions.
While I am doing more public appearances than in the past, I am open to invitations.
“Zero-based budgeting” often starts with the implicit assumption that something is needed, and the goal is efficient use of manpower and budget to achieve specified outcomes. Internal consensus is often all that is required.
What I am proposing is a bit broader: establishing a zero-based rationale for why anything is needed from any specific level of government, as well as how to successfully and efficiently deliver relevant and needed outcomes. The analysis must be capable of being communicated to external audiences whose buy-in is required.
Zero-basing analysis of FDA (which I am not suggesting is needed) would, therefore, start with establishing whether safe food and drugs needs government oversight (which we all take for granted), rather than starting with how that function can be performed most efficiently.