In multiple recent submissions, FDA has asked for additional work that:
- Will not address a core safety or efficacy concern;
- Will not meaningfully change the known benefit–risk profile;
- Will not result in a change to the design of the product; and/or
- Will only delay eventual clearance, approval, or classification.
In each of these cases, there were clear, less burdensome paths that still would have protected patients and maintained the integrity of the review process. However, those paths were not chosen. The best way I can describe what I am seeing is an institutional “immune response” to the broader political environment and leadership changes over the past few years.
A few compounding FDA decision factors are as follows:
- Loss of experienced staff (including those who helped with Center assignment and industry education);
- Senior reviewers moving into management roles where their decision-making is filtered through more layers;
- Newer reviewers who are still finding their footing, over-relying on consulting reviewers and then sending sponsors long, fragmented deficiency letters instead of a coherent, integrated decision; and
- A largely remote workforce, which makes it harder to mentor new staff, build judgment, and resolve borderline issues quickly and informally.
None of this is about bad people or bad intentions. Most FDA staff I work with care deeply about patients and take their jobs seriously. However, system-level shifts are pushing the culture away from the “least burdensome” standard that’s written into law and guidance.
For industry, this means a few practical things:
1) You may need to work harder to frame and defend a least-burdensome approach in your submissions and responses;
2) You should be prepared to propose concrete alternatives when you’re asked for studies or analyses that don’t move the needle on risk or uncertainty; and
3) You may need to escalate respectfully and invite more senior staff into the discussion when the ask is disproportionate to the risk..
My goal in sharing this is not to bash FDA. It is to acknowledge a reality many Clinical Sponsors are feeling but may not be articulating: the process is getting heavier in ways that do not translate into better decisions.
REFERENCE: Linked In; 19 DEC 025; David Pudwill (FDA professional) – reposted; This article first appeared on David Pudwill’s LinkedIn page and is published here with permission.