The FDA's New Cancer Boss Has a Plan (and It Involves Robots)

The consequences are already showing up. The direction is consistent with everything we're hearing about review strain.

Here's the problem with losing experienced oncology reviewers: you can't just replace them with warm bodies. Reviewing a cancer drug submission is incredibly specialized work. By the GAO's own assessment, training new reviewers to full performance can take years. It's like losing your head chef and trying to replace them with someone who just finished culinary school. The food will eventually be fine, but not tonight.

De Claro's plan targets FY2026 hiring focused on "mission-critical clinical and nonclinical review staff." He's trying to rebuild capacity that was lost to retirements and attrition before the pipeline backs up even further.

Enter the Machines

The second priority is where things get interesting. De Claro wants to deploy AI tools to assist with regulatory review.

This doesn't mean an algorithm will decide whether your cancer drug gets approved. Let's be very clear about that. The FDA's approach treats AI as a helper, not a replacement. Think of it less like self-driving cars and more like GPS: the human is still steering, but the technology helps them get there faster.

The OCE has launched what it calls its Oncology AI Program, which is exploring how AI can help with tasks like literature screening, adverse-event detection, and document analysis. The agency has already been running AI pilots for internal review work, including generative AI tools that help reviewers dig through massive submissions more efficiently.

In January 2025, the FDA issued draft guidance on using AI to support regulatory decisions. The key principle is a risk-based credibility framework: the AI's output is judged based on its specific "context of use." Translation: if you're using AI to flag potential safety signals in a 10,000-page submission, you need to prove the model is reliable for that specific task, not just generally impressive.

By 2026, the Oncology AI Program has reportedly shifted its focus toward regulatory review specifically, rather than broader research applications. That's a signal that de Claro sees AI as a near-term operational tool, not a distant science project.

The Bigger Picture

Beyond staffing and AI, de Claro outlined two more priorities: streamlining oncology drug development and increasing U.S. clinical trial enrollment. Both are long-standing goals at the OCE, but the enrollment push is worth noting. It suggests the new chief is thinking not just about how fast drugs get reviewed, but about whether enough American patients are participating in the trials that generate that data in the first place.

The OCE already has tools designed to speed things up, like its Real-Time Oncology Review program and Assessment Aid initiative. De Claro appears to be building on that foundation rather than tearing it down, which is probably reassuring to an industry that's had its fill of regulatory whiplash.

Why You Should Care

The FDA's oncology office is the gatekeeper for every cancer drug that reaches American patients. When that office is understaffed, reviews slow down. When reviews slow down, drugs sit in limbo. And when drugs sit in limbo, patients wait.

De Claro is essentially making a bet: that he can hire fast enough to stop the bleeding while simultaneously deploying AI to multiply the productivity of the reviewers he has. It's a two-front war, and both fronts need to hold.

The optimistic read is that this is exactly the right approach. A long-tenured FDA veteran who understands the machinery is bringing modern tools to bear on a very old problem (too much work, not enough people). The pessimistic read is that federal hiring is slow, AI deployment is slower than anyone promises, and the oncology pipeline isn't going to wait politely while the FDA figures it out.

The truth is probably somewhere in the middle. But for the thousands of cancer drugs working their way through development right now, de Claro's ability to execute on these priorities isn't an abstract policy question. It's the difference between a review that takes months and one that takes years.

J&J Just Locked Down a $5 Billion Drug Until 2035. Generics Can't Touch It.

A federal court just blocked generic Spravato until 2035, handing J&J a decade of exclusivity on a drug headed toward $5 billion in peak sales. For generics companies, the ruling is a costly warning shot.