The FDA Reviewer Is Human: Writing Submissions for Regulatory Readers, Not Aliens

I strongly suggest that most sponsors still write as if FDA reviewers read slowly, linearly, and generously. My experience says the opposite: the FDA reviewer is a time-starved, human decision-maker. The reading model I constantly talk about starts from that premise. In turn, I argue that the model I espouse should change how you design every page in every document you submit to FDA and EMA.

I always argue to get the "So what?" up front (I am practicing what I preach in this article).

“What planet are they from?”
On a client call last week, I was challenged with this query: “Well Greg, your model of reading behavior is interesting. But how do you know it applies to people working at FDA?”

That question triggered a quiet “WTF?” for me—not because the question was rude, but because of what sat underneath the query. I hear variations of the same line in my workshops:

• “What planet is this reviewer from?”
• “I don’t read like that.”
• “But I know a person at FDA who says they do…”

My answer never changes: “Trust me, all regulatory agency reviewers are a carbon-based life forms like you and me. They are not from some exoplanet identified by the Kepler telescope.”

The deeper problem is not skepticism about what I present as a reader behavior model. The deeper problem is a persistent myth: the FDA reviewer is an alien whose behavior sits outside normal human reading constraints and we cannot predict how they will react.

This myth feels convenient. Mythology helps development teams avoid harder questions:

• Did we design this document for how the busy, highly selective, decision-making reader actually reads under pressure?
• Or did we design it for how we wish they read if they had unlimited time and attention?
  
  

The myth of the alien FDA reviewer
Many teams carry unspoken mental models of the regulatory reader:

• A perfect logician who reads line-by-line.
• A hostile outsider with strange expectations and who just cannot appreciate our science.
• A black box entity whose behavior cannot be predicted.

These models create comfort stories:

• “They just didn’t read it properly.”
• “The issue came from their wrong interpretation, not our data or analysis.”
• “They just didn’t want to work hard enough. They get no pity points from me.”

The deflecting exhortations protect the development team from added discomfort. In reality, your FDA reviewer:

• Faces high-volume reading across multiple projects.
• Works inside a clock and a meeting calendar, not a reading retreat nestled in the Catoctin Mountains of Maryland.
• Carries personal accountability for public health decisions.

In other words: a human with limited working memory, limited time, and real stakes. Blaming “lack of time to read properly” misses the point. The real issue often looks like this: The document was never written for the way humans must read when time and risk collide.

What my reading model really describes
The model I use to explain how expert readers move through complex documents under pressure grew out of the reading research community and the evidence we have collected formally and anecdotally in conversations with regulatory agency reviewers.

The observed and anecdotal behavior is clear:

• Readers jump across content
• Readers triage--What must I understand now? What can wait?
• Readers trace claims
• Readers conserve cognitive effort
• Readers optimize for decision risk

The model I use is a description of high-stakes human reading: Triage → Navigate → Sample → Trace → Cross-check → Decide.

If that sounds familiar to your own behavior as a clinical lead, safety physician, regulatory writer, or statistician, then I call it good. This is the point.

Why our reading model applies to FDA reviewers
Back to the question: “How do you know your model applies to people working at FDA?”

Here is the short answer: nothing about the FDA reviewer exempts them from human cognition or organizational pressure. Four reasons matter.

Shared cognitive hardware
FDA reviewers are expert clinicians, statisticians, and pharmacologists. They are not endowed with extra RAM. They still:

• Hold only a few chunks of information in working memory at once
• Experience overload when faced with dense, undifferentiated text
• Rely on cues—headings, topic sentences, structure—to build a mental map

Keep in mind: Professional training refines judgment and process. Training does not rewrite the basic limits of attention and memory.

Structural pressures of the role
Consider the environment:

• Multiple applications and supplements in play.
• Internal meetings, advisory prep, safety signal reviews, emerging data, and those dreaded Type B Meeting briefing books.
• Formal review clocks and deadlines.
• Public and political scrutiny as well as legal accountability.

These pressures force triage and selective reading. No one in such an environment reads every paragraph with equal depth. The reading behavior model we use represents a rational coping strategy used by agents in the FDA and EMA.

Consistency across contexts
What I argue as reading behavior appears in:

• Drug sponsors
• Ethics committee reviews
• HTA and payer evaluations

When context looks the same, (complex evidence, compressed time, meaningful risk) reading behavior converges. FDA reviewers are not the exception. They are the most visible example.

If the reading model I describe does not apply to FDA reviewers, then this would imply the "agency" discovered a way around human cognition that the rest of us lack. No evidence supports that belief. People at FDA are indeed carbon-based life forms from good ol' Planet Earth.

“How should we structure this document if our success depends on a busy human understanding the core message in one pass?” This is the question to be addressed in every document planning meeting.

A final thought: If your organization wants to stress-test your current draft documents against a robust reading and decision-efficiency model, then reach out to me.