​The Dangerous Habit of Letting Draft 1 Do Your Thinking

Why the “Do” Must Precede the Draft in Regulatory Writing
Why do regulatory teams treat Draft 1 like a mirror—something to react to—rather than a blueprint for strategic thinking? Because reacting feels easier than planning. But that shortcut costs time, clarity, and purpose. It’s easier to critique a sentence than to commit to a message. Yet regulatory writing demands something more deliberate: the “do.”

The “do” is the document’s core function—what you want the regulatory reader to
understand, agree with, or act on. If that function isn’t clear, you’re not writing strategically.

You’re just filling pages.

When Draft 1 drives the thinking, documents lose purpose—and teams lose time. Real thinking often begins only after Draft 1 is written. By then, the window for deliberate planning has already narrowed.

I raised this point with my consulting partner, Stephen Bernhardt. We discussed creating a heuristic tool to guide early drafting. I pushed back: “That assumes teams are willing to think hard before they write.” In my experience, they are not. Most treat Draft 1 as the start of thinking—not the result of it.

Medical writers routinely build shells—basic outlines mistakenly called “prototypes” (a separate issue I’ll explore in a future article). These pseudo-prototypes often get ignored.

Why?

• They feel incomplete: Skeleton drafts with headings or placeholder bullets don’t trigger urgency. Teams say, “This feels like an outline—we’ll get to it later.”
  
• They feel premature: Teams often conflate writing with thinking. They wait to engage until the draft sounds polished. Prototypes, by contrast, demand early decisions.
  
• They feel threatening: A good prototype raises hard questions: What’s the message? What’s the structure? What are we trying to prove? These questions shift stakeholders from passive reviewers to active contributors—before they feel ready.

Prototype reviews often fail because no one makes a formal ask. No guided questions. No
consequences for silence. The path of least resistance is to do nothing: “I’ll wait for the full
draft.”

Many teams also delay message planning until the full data set is locked. But by then, it's too
late to shape the narrative—only to react to it.

Another problem, if leadership doesn’t engage, neither will the rest of the team. Reviewers take their cue from the top.

The real issue? Teams skip the pre-draft choices that matter most: defining the document’s purpose, aligning on its message, and designing its logic. Teams avoid thinking about information design—the deliberate structuring of content to make key messages discoverable, logically sequenced, and aligned with the reader’s task.

Instead of planning, teams treat the first draft as a mirror—using it to react rather than to
think.

The Problem: Drafting Replaces Thinking
When Draft 1 stands in for strategy, documents suffer. People drop into surface-level edits. They tweak sentences, debate word choices, and micromanage formatting—without questioning the logic beneath it. Few ask: Should this section be saying these things in this way? Fewer still ask: What is this section supposed to do for the regulatory reader? Most cannot answer those questions. I know—because it’s the first thing I ask in every workshop I run.

In this dynamic, writing becomes the trigger for strategy, rather than the output of it. When
teams treat the draft as a heuristic for meaning, it signals deeper problems:

• Avoidance of upstream decisions: Editing words is easier than confronting uncertainty about message, logic, or evidence.
  
• Lack of document function clarity: Teams assume documents are meant to “report.” Report what? Data? A document should argue, justify, or demonstrate—not simply display.
  
• Mistaking writing for thinking: Drafting is execution. The strategy should come first. This habit isn’t just inefficient—it’s risky. It leads to documents that:
  
• Drift from purpose because none was defined
  
• Respond to language rather than logic
  
• Dilute the message under the illusion of refinement

By the time the team starts asking the right questions, the draft has already become an anchor. Once written, inertia sets in. The document looks finished—even though the thinking isn’t. That’s when teams
start rearranging deck chairs on the Titanic—refining detail while ignoring structural failure.

A Better Way Forward
The fix is simple—but not easy: stop letting Draft 1 lead the thinking.
Instead:

• Define what the document must do—not just what it must say. Start with function.
  
• Plan the message before writing. What’s the claim? What’s the evidence? What’s the logic?
  
• Use Draft 1 for execution—not exploration.
  
• Tackle the real questions early

Closing Thought
When documents are drafted before critical thinking is complete, teams end up managing words—rather than shaping arguments. Regulatory reviewers can feel the difference. I know this from years of feedback and firsthand conversations.

Before writing a single sentence, ask:

• What do we want the regulatory reader to understand or do—because of this document?
  
• If the answer isn’t clear, you’re not ready to draft.

Writing without purpose isn’t progress. It’s risk.