Episode 3: Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO | Plus, PRIMA Implant + GLP-1 Data Dump

RetinUp – Episode 3: Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO | Plus, PRIMA Implant + GLP-1 Data DumpHosts:John Kitchens, MDScott KrzywonosGuest:Alexander Gaffney, VP of Regulatory Policy & Intelligence, Agency IQ / POLITICOShow Summary: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.Topics Covered:PRIMA retinal implant: wireless innovation and its surgical challengesThe trade-off between functional vision gains and expanded atrophy areaGLP-1 receptor agonists: mixed data on AMD, DR, and DME riskFDA shutdown implications for ophthalmic trials and approvalsThe reduction in force across FDA divisions and its effect on review capacityHow new leadership and the National Priority Voucher Program aim to modernize the agencyWhy backlogs could extend into 2026 for gene therapy and TKI programsKey Quotes:“I’m less worried about the shutdown itself — I’m worried about what happens afterward.” — Alexander Gaffney“You might not be able to read or drive, but that peripheral vision is what lets you move through the world. Losing more of that matters.” — John Kitchens, MD“We don’t always know what we’ve lost — how much faster certain drugs might have reached patients.” — Scott KrzywonosCredits:Production & Marketing: Laura BrownBusiness Operations: Liz HoganListen and Subscribe: RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube