Does FDA Reviewer Turnover Justify Bulky Regulatory Submission Documents?

A few weeks ago, during a workshop on lean writing for regulatory submissions, I was hit with this
challenge from a participant:
“Greg, we overload documents with details and redundancies because of the huge FDA Medical
Review Officer (MRO) turnover. We need to make it easy for new people. New reviewer, limited
context—we’ve got to give them the story in one place.”

​He cited some details that I’ve since seen echoed elsewhere:

• FDA medical reviewer turnover in some divisions exceeds 20% annually.
• Average tenure for a medical review officer in certain therapeutic areas is just 2.1 years.
• GAO reports and workforce modernization plans note that high turnover disrupts continuity and institutional knowledge.
• Junior staff are often thrust into senior decision-making roles prematurely.

The concern is reasonable, but the approach is wrong. Here’s the distillation of my response:

High turnover isn’t an argument for long, dense documents—it’s an argument for leaner ones.
Why?

1. Time is short. Overloaded reviewers juggling multiple applications don’t have the bandwidth to wade through bulky documents and ambiguous prose.
2. Verbosity creates risk. Inconsistent repetition and vague writing increase the odds of misinterpretation—especially if submission work is handed off midstream.
3. Volume of information is rising. Larger, more complex studies with more endpoints. Therefore submission loads are up. You cannot mint more hours in a day, you can only take more days to review what has been submitted.
4. RFIs are increasing due to complexity. Unclear writing that is ambiguous, redundant, and provides few answers likely leads to more clarification requests and back-and-forth exchange with FDA regulatory agents.
5. NLP tools are here. For instance, FDA rolled out Project Sentinel in 2017 for triaging safety information. NLP is being explored to automate the review of clinical trial protocols and extract key elements and also in analysis of real world evidence. This means lean writing applying clarity, cohesion, and consistent structure are not just helpful; they’re increasingly necessary.

Still, I wanted to sharpen the counterargument—so I asked my consulting partner Stephen Bernhardt to
weigh in with his thoughts:

Steve commented,
The upside is your workshop participant is thinking about the reviewer’s situation—and that’s good. But
let’s flip the logic.
If I’m new to a review, I don’t want more content. I want better content. What does “better” look like? I
suggest the following:

• Well-designed IBs and Briefing Books with up-to-date information and clear links to key learnings
• Background sections that offer context, not an exhaustive history.
• Section previews and topic sentences that help me quickly scan and sort what I need to read.
• Clear visual design not just for tables and figures, but for text as well. Smart information design is needed to make processing easier.
• Frontloaded main messages in all sections and clear implications that address the “So what?”Navigation cues explaining why I might want to follow a hyperlink and consult another document.

What do new reviewers actually need? The same thing everyone else needs: Documents designed for
rapid comprehension.

And here’s a question I often asked development teams when consulting:
“When you’ve been new to a project, what helped you get up to speed? What slowed you down?”
I cannot recall anybody telling me: “Longer documents would’ve helped.”

Greg (closing thought):
I understand how people worry that lean writing leaves out what they believe is essential context. We
are dealing with conditioned behavior built up in people who are used to seeing obese documents. But
the real risk is this: bloated documents make it harder for new reviewers to find what they are looking
for, understand the “So what?” and then take action—that is, make a decision.
Steve (closing thought):
Let's trust our instincts that tell us that often less is more and that busy readers will thanks us for
documents that are designed to help them make good decisions.

What do you think?
Have you faced similar pushback when advocating for lean regulatory writing? How do you respond to
the “but reviewers need everything in this document, we gotta be transparent, we gotta make it easy
for them by putting everything in one place” argument? Please share your thoughts.