Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported, with a caveat. The quoted sentence is introduced by 'For example', so it is an illustration of the preceding operative sentence ('In addition to appearing with or near benefit presentations, risk information should appear as an integral part of the piece, just as benefit information does'). It is not a numbered Example block, and it states the norm in FDA's own recommendation voice ('a prescription drug ad should not present risks only on a brief summary page'), so it does establish a checkable, violable norm — but the rule should be anchored on the operative sentence with the brief-summary case as its application.
- Overstated in modality. The source says 'should not'; the rule says 'must not limit its risk disclosure'. A non-binding guidance recommendation has been written as an obligation.
- Overstated/misstated in scope by the added placement condition. The source says only 'brief summary page'; the rule and check add 'at the end' and 'trailing'. Nothing in the quoted sentence limits the problem to a brief summary that appears last, so as written the rule would let a piece that confines risks to a brief-summary page positioned elsewhere escape the check.
- Atomic: a single condition — risk content appears only on the brief summary page. The trailing clause ('risk information needs to be integrated into the main piece') is the positive statement of the same condition rather than a second checkable requirement, though it overlaps with US-RISK-030's broader distribution rule; keeping this rule's check focused on the brief-summary case preserves the distinction.
- 'judgment' is defensible: although whether any risk content exists outside the brief summary is close to presence/absence, the operative question the check asks — whether risk content is genuinely integrated with the main promotional message — turns on adequacy and prominence.
- Authority 'guidance' matches the source document and the rule claims no more than the document's authority. Category 'risk-disclosure', severity 'warning' and the print medium limit are justified: the passage sits in Section III.C.1 and concerns print ads with brief summary pages. The locator matches.
- The quote is a complete sentence, though it opens with 'For example,' and therefore carries its illustrative framing into the rule.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is two complete, consecutive sentences from Section III.C.1 of this draft guidance, under 'Location of Risk Information within a Part of the Promotional Piece'. It supports the rule. The rule body keeps 'should' and 'should not', and the print-medium limit is justified by the section heading 'Print Promotion'.
- The title 'Do not confine risk disclosure to a brief summary page' is an imperative prohibition. The source says only that a prescription drug ad 'should not' present risks only on a brief summary page, so the title turns a non-binding recommendation into an apparent obligation.
- The 'Escalate when' condition ('When all substantive risk content appears only on a brief-summary page') is not an ambiguity to escalate. It is exactly the situation the rule says to flag, so escalating it instead of flagging it contradicts the Check.
- Judgment is correct: whether risk content is 'integral' to the piece is an impression-based assessment (compare Examples 15-17). Warning severity suits a recommendation from a draft guidance.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Quote is verbatim, two complete sentences from Section III.C.1 under 'Location of Risk Information within a Part of the Promotional Piece'; locator is correct.
- Supported and kept as a recommendation: 'should' is preserved in the title, the rule and the quote, and Examples 15 to 17 back the idea that risk information must be integrated with the piece rather than set apart.
- Not atomic as written: the rule statement opens with 'In addition to appearing with or near benefit presentations, risk information should ...', which asserts a separate proximity recommendation that the check does not test. It is a different, independently checkable requirement, and a reviewer reading the rule could apply it here.
- Whether risk content is an 'integral part' of the piece is a judgment call, so 'judgment' is correct. Warning severity is defensible for a draft guidance ('Draft — Not for Implementation').
- Limiting applies_when to print matches Section III.C.1 (Print Promotion). Narrowing to prescription drug ads matches the example given in the source.
- This is the only rule in the packet, so there is nothing to duplicate.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim from Section III.C.1 (Print Promotion), under the bullet 'Location of Risk Information within a Part of the Promotional Piece', and is two complete sentences: the recommendation that risk information appear as an integral part of the piece, and its illustrative example about a brief summary page. Together they are one checkable requirement, so the rule is atomic.
- Title and body keep the source's 'should' / 'should not'; no overstatement. Judgment determinism is correct (whether risk is 'integral' is an impression call, as Examples 15 and 16 show). Print scope in applies_when matches the section heading; warning severity is defensible for guidance.
- The rule body narrows the source's general principle: the source says risk information should appear as an integral part of 'the piece' (any print promotional piece for drugs or devices; Example 16 is a sales aid), but the rule rewrites it as 'a prescription drug print ad'. Only the illustrative example is limited to a prescription drug ad. As written, a reviewer could conclude the rule does not reach a device brochure or a drug sales aid, contrary to the source and to the rule's own Check ('the piece').