|
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?
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:
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:
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:
Writing without purpose isn’t progress. It’s risk.
0 Comments
Drug development regulatory submission documents are among the most structured documents in existence—and yet they are often developed in the most chaotic way. As I mentioned in my previous article, teams wait too long to think, treating Draft 1 as the beginning rather than the outcome of deliberate information design planning. Instead of aligning early on logic, purpose, and reader needs, teams begin reacting to prose—often in the form of a partial draft or outline labeled as a “prototype.”. The result? Wasted cycles, misaligned arguments, poor document flow, and late-stage rework that drains time and undermines confidence—especially in mission-critical documents like Clinical Study Reports and the eCTD Module 2.5 Clinical Overview. I suggested in my previous article that development teams need to reconsider what they are generating as document prototypes. Most teams mistake an outline for a prototype. But there’s a key difference:
the establishment of the intellectual architecture of the document. The “So what?” and the “Why?” that are at the core of evaluating, justifying, and arguing. This is the foundation of regulatory writing. After all, the purpose of a submission is not to describe—it is to evaluate, justify, and argue. Those three writing actions sit at the heart of how health authorities assess benefit–risk. From “Primitive Forms” to Design Thinking The word prototype comes from the Greek prototypon—meaning “primitive form” or “original model.” Historically, the concept of building rough models or mock-ups has existed for centuries. However, it was not until the late 1960s that prototyping emerged as a recognized approach in document information design. In software, prototyping gained traction in the early 1970s as an explicit strategy to manage evolving requirements. Winston Royce—often miscredited with creating the Waterfall model—emphasized the importance of incorporating prototyping within code writing to reduce risk. By the 1990s, “document prototyping” became mainstream in many industries that demanded logic and tracebility. Prototyping is not about language and shell tables. It is about early validation of logic, flow, and alignment. A concept that is either poorly understood or undervalued in many Pharma houses. Prototyping as Structured Thinking A real prototype is not a template filled in with placeholder XX, Y% and p-value of 00.0X. A prototype is the framework for judgment. A prototype helps teams clarify what each section must do—not just what it must include. One powerful tool to use is a prototype planning matrix, which breaks down each section into five core elements:  This is the logic scaffold that the decision-making regulatory readers are looking for. Let's walk through an example:  Keep in mind the “So what?” The message is not a study endpoint. The message is a decision in sentence form. The data supports that decision, but the message must guide how the data is presented and evaluated. Teams tell me all the time, “it is all about the data.” I get it. It is indeed about the data. So, during prototyping is the time to make the data needs visible. Where do you need a table, figure, or reference? Too many teams wait until late in the document lifecycle to consider what tables or figures will help carry their argument in a Clinical Overview. Writing Actions and Functional Thinking In my approach, each part of the prototype needs an associated thinking task. What does this section “do” for the reader. It is not about the reporting, it is about the doing:
A strong prototype exposes reasoning, not just structure. It shows how the argument flows, where the evidence lands, and whether the logic holds—before prose locks your thinking into place. ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ New Article: Why Regulatory Writers Need to Prototype Smarter In drug development, we create some of the most structured documents in the world—yet they’re often developed in the most chaotic ways. Too many teams treat Draft 1 as the start of thinking, rather than the outcome of it. In my latest article, I explore why regulatory submission documents—especially eCTD Module 2.5—require prototypes that reveal logic, not just structure. I walk through the difference between outlines and prototypes, introduce a five-part heuristic planning tool, and share examples of how to build prototypes that support decision-making for regulatory readers. It’s not about formatting—it’s about function. It’s not about writing early—it’s about thinking early. Read the full article here: https://www.linkedin.com/pulse/why-regulatory-writers-need-prototype-smarter-gregory-cuppan-solmc Let me know how your team approaches document prototyping—and what gets in the way of doing it well. In regulatory writing, fluency is often praised. To a fault, I might add. Documents that “read well” are
seen as polished, professional, and persuasive. But fluency can be deceptive. A troubling phenomenon is increasingly visible across high-stakes submission documents that I can access: writing that is elegant, but logically unsound. The Problem: Elegant Nonsense These are documents—often Clinical Overviews, Briefing and AdComm Books, or 2.7 Summaries—where the language flows, the sentences vary in rhythm and length, and the vocabulary sounds convincing. But when you interrogate the logic underneath, something’s missing. There is no connective reasoning. The claims float. The evidence is absent, circular, or only loosely linked. I call this elegant nonsense—writing that sounds intelligent but lacks logical structure or evidentiary support. Examples of Elegant but Hollow Writing
high-stakes submission documents? Why This Happens
Why It is Dangerous Regulatory readers are trained to look beyond the language. They must detect bias, weigh risk, evaluate strength of evidence, and make yes/no decisions under pressure. When documents rely on polished language to mask weak thinking, reviewers lose confidence—not just in the section, but in the entire argument. This is the affective level of information design, as suggested by Saul Carliner. Carliner noted that when writing feels effusive (demonstrative, lavish) or evasive, then the writing erodes the reader’s trust—not only in what is stated, but in why it is stated that way. In regulatory contexts, that erosion is consequential: it casts doubt on the sponsor’s judgment and forces the reviewer to work harder to separate signal from gloss. Elegant writing that lacks rigor is not just ineffective—it can be misleading. How to Spot and Fix It Interrogate every conclusion – What is this based on? Where’s the data? Is the reasoning clear? Replace vague synthesis with structured logic – Instead of “Taken together,” show how the pieces fit. Simplify to clarify – If the sentence reads like corporate poetry, ask: is it hiding uncertainty? Separate fluency from function – Does this paragraph sound good, or does it do its job? Consider the phrase: “This study is adequate and well-controlled.” The phrase appears routinely in regulatory documents—concise, confident, and aligned with regulatory guidance language. But unless the concepts are substantiated, this sentence is nothing more than elegant shorthand. Why It Sounds Smart It mimics the regulatory lexicon (such as 21 CFR 314.126). It conveys confidence in the study's design. It’s often used to bridge to conclusions about efficacy or labeling claims. Why It May Be Elegant Nonsense If the surrounding text contains no analysis of the “whys” for:
must move from elegance to substance. Another Example: “The Safety Profile Was Manageable” This phrase shows up in nearly every Clinical Overview and Summary of Clinical Safety I read. The phrase suggests confidence, but what does it actually mean? Why It Sounds Smart It’s concise and optimistic. It implies clinical actionability—something prescribers and regulators care about. Why It May Be Elegant Nonsense “Manageable” sidesteps reasoning. The term offers a verdict without evidence. I suggest that without explaining what was managed and how, this phrase is:
informative work. “Manageable” carries a positive emotional valence (“feel good factor”) without conveying analytical substance. It is language designed to reassure, not inform. Bottom Line Polished phrases like “adequate and well-controlled” or “manageable safety profile” only serve the reader when tethered to evidence and logic. Elegant language that obscures complexity—or avoids specifics—undermines trust in the message. In regulatory writing, clarity must be earned. You make a claim, you better prove it. A Better Standard The goal of regulatory writing is not to sound polished. The goal is to communicate rationales for interpretations and decisions—clearly, truthfully, and logically. Regulatory decisions shape public health. Regulatory reviewers must decide under pressure, with limited time. Our job as writers is not just to report and write elegant prose—but to demonstrate thinking on the page. Writing that hides uncertainty or skips reasoning does not just fail the reader. It fails the process.
Also published to LinkedIn July 2, 2025. https://www.linkedin.com/pulse/when-elegant-writing-masks-flawed-thinking-regulatory-gregory- cuppan-qmmrc In my observation of efforts to embrace lean writing across regulatory submission documents, I find a troubling trend has emerged: I am seeing lazy writing, not lean writing.
Pharma clients are increasingly voicing concerns that critical content—especially in key “end-game” submission documents like Module 2.5—is being trimmed so aggressively that essential context, rationale, and reader guidance are vanishing altogether. In some submissions, a placeholder sentence has replaced the entire substance of a required overview discussion. For example I have found the following in a Clinical Overview I was asked to review: "For Pop PK, refer to Section 2.7.3.x. Where the text states: No concerns regarding intrinsic or extrinsic factors. For full details, refer to 5.3.3.x." This is not lean writing. This is abdication. I expect the discussion of Pop PK in the Clinical Overview to provide a concise but informative synthesis that supports the understanding of dose selection, variability, and applicability across patient subgroups. I want a high-level summary on the data sources and modeling approach. I do not want to leave the document to learn these details. Remember, the busy, selective regulatory reader's needs are immediate, not later. Give me the "So what?" here and I will decide if I want to follow the link. Cutting to the Bone (or Into It) The intent of lean writing is to eliminate noise, not substance. Lean writing means focus on what a section is to “do” and what is the “So what?”. Lean writing is about reducing clutter—repetition, irrelevance, hedging, verbosity—not impacting clarity, logic, or the reader’s ability to understand, navigate, and assess. The "write it once and refer" principle does not mean we get to skip the responsibility of previewing what is important, or overviewing the details that support the “So what?” and why the details matter. Lean Writing Is a Reader-Centered Discipline Lean writing is not about writing less—it is about writing smart. Lean writing designs information to reflect reading behavior. Lean writing anticipates the reader’s questions and designs plans to provide a clear response. The lean writing style builds scaffolding within a section so the reader can move efficiently from “So what?” overview to evidence and analysis. Lean writing provides the mental handles that allow the reader to judge the relevance, reliability, and meaning of the details found elsewhere. Lean writing reduces noise, not meaning. And meaning needs structure, context, and care. Hyperlinking without context and care for the reader is not lean. It is lazy. The busy, decision-making regulatory reviewer is not looking for breadcrumb trails. They are looking for clarity, logic, and confidence that you, the Sponsor, got the “So what?” right. https://www.linkedin.com/pulse/lean-writing-what-we-want-lazy-gregory-cuppan-etufc |
AuthorGregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises. 
Archives
December 2025
Categories |
RSS Feed
Services |
Company |
|
