Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO

11/11/25

In this episode, Scott calls in from the Outer Banks to discuss two major clinical headlines before turning to federal policy. First up is the PRIMA retinal prosthesis, a wireless subretinal chip that helped patients with geographic atrophy regain partial reading vision. Then, Scott and John analyze the rapidly expanding — and often contradictory — body of research on GLP-1 receptor agonists and their links to retinal disease.

In the second half, they welcome Alexander Gaffney from POLITICO’s Agency IQ for a deep dive into how the ongoing government shutdown and widespread staff reductions are affecting the FDA’s ability to review and approve ophthalmic therapies. From PDUFA carry-over funds to workforce attrition, Alec explains why the true impact may not be the shutdown itself, but the backlog that follows.

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