Gottlieb Warns Leaner FDA Will Challenge ClinOps
By Dan Schell, Chief Editor, Clinical Leader
I was in the front row at DPHARM in Philadelphia on September 16 as Scott Gottlieb, MD, former FDA commissioner, joined Lilly’s Janelle Sabo on stage. What unfolded was less a fireside chat and more a sober reality check for anyone in ClinOps. Although, I will admit, many of the issues and challenges discussed were likely well-known to the packed house, which isn’t bad nor wrong. I mean, it was pretty unlikely that he was going to come on stage and start rattling off a bunch of controversial comments. Probably the most “controversial” thing he said — in my opinion — was, “It's surprising to me if you look at Marty Makary's public calendar, you'll see he's meeting all the time with biotech CEOs. I don't remember taking a single meeting with a regulated drug or device company when I was there, and that was quite intentional. I met with the trade associations, but not with individual companies because I didn't want to create a perception that I was the complaint desk or that the agency was subject to political lobbying.”
This was still a big win for DPHARM, and I did find the conversation engaging, so let me give you some of my highlights. Oh, and kudos to Sabo who did a great job asking intelligent and sometimes complex questions, even if they were vetted ahead of time.
More Staff Loss & Early-Stage Innovation Risks
Sabo opened by asking about the FDA’s ability to keep pace in today’s volatile environment. Gottlieb didn’t hesitate: The agency is facing a historic loss of staff. A quarter of its clinical review workforce has already departed, and he warned that the number could hit one-third by year’s end. For ClinOps teams, that means fewer points of contact, slower reviews, and less consistency across divisions. The agency simply doesn’t have the bandwidth it once did.
Sabo pressed Gottlieb on what this environment means for innovation, especially in early-phase work. He explained that while late-stage applications are still getting prioritized to meet PDUFA deadlines, the real pain is in Phases 1 and 2. Applications in those stages are often shelved so the FDA can cover later filings. His advice to sponsors: Don’t rely solely on project managers, many of whom have turned over. Instead, find ways to build direct relationships with review teams, and be strategic about what issues are raised to FDA leadership. Escalating product complaints to the commissioner’s office, he said, only makes reviewers more cautious.
Sabo pointed out the risk of innovation leaving the U.S. entirely. Gottlieb agreed, noting that countries like China and Australia are pulling more first-in-human studies because their systems are faster and more flexible. Unless the FDA modernizes its early-phase processes, more companies will continue taking those trials overseas.
Where Progress Is Still Possible
Not everything was doom and gloom. When Sabo steered the conversation toward decentralized and community-based research, Gottlieb lit up. He agreed these models can ease patient burden, diversify enrollment, and bring rural providers into the fold. For ClinOps leaders, this was a reminder that site-light and hybrid designs aren’t just trendy — they’re essential to keeping studies viable in today’s climate.
Still, Gottlieb underscored that the policy frameworks supporting these innovations are moving slowly. Guidance on digital health tools, AI, and other emerging methods has stalled, leaving ClinOps teams to innovate without much regulatory clarity. The FDA’s reduced engagement in public forums and technical meetings only adds to the uncertainty.
Patients Are There, The System Isn’t
Sabo closed by pulling the conversation back to patients. She noted how hard it still is for people to find and enroll in trials, even with tools like ClinicalTrials.gov. Gottlieb agreed, pointing out that technology now makes it easier than ever to identify eligible patients scattered across small practices; but enrolling them remains a major operational barrier. Current rules make it difficult to support those smaller community sites, effectively sidelining patients who could benefit most. For ClinOps teams, the message was stark: The science is ready, but unless the system adapts, operational bottlenecks will keep slowing progress.
From my front-row seat, the takeaway was clear: The FDA of today isn’t the FDA of 2017. For ClinOps professionals, that means preparing for slower reviews, more friction in early development, and less policy clarity. But as both Sabo and Gottlieb emphasized, decentralized models, thoughtful regulatory engagement, and smart use of technology still hold real promise for keeping trials moving — even in a strained environment.
