Disclose conflicting conclusions from other scientifically sound studies, with citations

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

When an SIUU communication includes a source publication primarily focused on a particular study, and this information is not already in the source publication, FDA recommends that the communication describe any conflicting conclusions from other scientifically sound studies addressing the same or similar hypotheses or research questions, and include citations for those studies.

Check

Apply only when the SIUU communication includes a source publication primarily focused on a particular scientific study or studies. Search for other scientifically sound studies on the same or similar hypothesis whose conclusions conflict with the source publication's. A finding is a scientifically sound, conflicting study on the same or similar hypothesis that is neither described nor cited in the communication or in the source publication itself.

Escalate when

Judgment is needed to decide whether another study is 'scientifically sound' and whether its hypothesis is sufficiently similar.

Where this comes from

Section V, Q2 · page 20. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:

…me. The Cochrane database of systematic reviews, 2(2), MR000033. <u> https://doi.org/10.1002/14651858.MR000033.pub3 </u> (reviewing 48 studies showing that “[s]ponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”). All material limitations related to the study design, methodology, and results. Any conclusions—from other scientifically sound studies that evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or analyses described in the source publication(s). The citations for any such studies should also be included. The publication date of any referenced or included source publication (if not specified in the source publication or citation). Q3. What presentational considerations should firms take into account for SIUU communications? There are several presentational considerations that can help ensure that SIUU communications are conveyed in a manner that enhances and does not interfere with HCP understanding and evalu…

Open the original at page 20 on fda.gov ↗Read our full copy →

Document: FDA guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: a36a07e1efd950b7a2a8f6b3…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Audiencehcp

Basisunapproved-use-scientific

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported: Q2's list of information FDA recommends firms include contains, for SIUU communications with source publications primarily focused on a particular study, a description of 'Any conclusions—from other scientifically sound studies that evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or analyses described in the source publication(s)', followed by 'The citations for any such studies should also be included.'
- The quote as recorded is a bare list item: it is a noun phrase with no subject or verb, stripped of the lead-in that makes it operative ('In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:'). Standing alone the quote does not state that anything must be provided, and it also omits the separate citation sentence that the rule statement relies on. That is a fragment that misrepresents the source and must be repaired.
- The rule statement itself correctly carries the two limits from the lead-in — source publication primarily focused on a particular study, and the information not already being in the source publication — so applies_when plus rule text together scope the rule properly; the scoping vocabulary has no field for these conditions, so stating them in the rule text is acceptable.
- Atomic is acceptable: the conflicting-conclusion description and its citations are two halves of one disclosure, and the source presents the citation sentence as an adjunct to the same item.
- Judgment determinism is correct — 'scientifically sound' and 'same or similar hypotheses or research questions' both require assessment.
- Authority 'guidance' is correct (Q2 is introduced by 'FDA recommends that firms include'), the rule keeps 'should', locator 'Section V, Q2' is right, and 'warning' severity is defensible for an omitted recommended disclosure.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source (Section V, Q2) does recommend that, for SIUU communications including source publications primarily focused on a particular study, firms describe conflicting conclusions from other scientifically sound studies on the same or similar hypotheses, and include their citations, where this is not already in the source publication. The rule text states this faithfully as an FDA recommendation, with its conditions.
- The quote is a bare list item. 'Any conclusions-from other scientifically sound studies ... in conflict with the conclusions ... described in the source publication(s).' has no verb and no subject. On its own it does not say what is recommended or when. Its lead-in ('In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:') appears earlier in the same list, separated by other items. Without the lead-in the quote misrepresents the source.
- Including the citations is part of the same disclosure, so the rule is atomic. It is correctly marked judgment ('scientifically sound', 'same or similar'), and warning severity and applies_when (hcp, unapproved-use-scientific) are justified.
- The Check leaves out both of the rule's conditions: that the source publication is primarily focused on a particular study, and that the conflicting conclusions are not already described in the source publication. As written, it would flag a conflicting study that the included publication already discusses.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported by Q2: in an SIUU communication that includes source publications primarily focused on a particular study, where the information is not in the source publication, firms are recommended to describe conflicting conclusions from other scientifically sound studies and include their citations. The rule statement correctly says 'FDA recommends'.
- The quote is a bare list item ('Any conclusions-from other scientifically sound studies...'). It has no subject or verb and cannot stand on its own. Its introducing sentence ('In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:') is separated from the item by intervening text (the other sub-items and footnote citations), so the rule needs a lead_in field.
- The title 'Disclose conflicting conclusions from other scientifically sound studies, with citations' is a bare command, but the source is a Q2 recommendation ('FDA recommends that firms include all of the following information'). The title overstates it.
- Judgment is correct because 'scientifically sound' and 'similar hypotheses' need assessment. applies_when and the Q2 locator are right.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a verbatim, complete list item from Section V, Q2, including its trailing sentence about citations. The lead_in 'In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:' is verbatim. That sub-list sits under 'FDA recommends that firms include all of the following information', so the item is a recommendation.
- The rule statement correctly says 'FDA recommends' and keeps both conditions from the lead_in: a source publication primarily focused on a particular study, and the information not already in the source publication.
- The title 'Disclose conflicting conclusions from other scientifically sound studies, with citations' is a bare command. The source is a non-binding recommendation, so the title overstates it.
- Describing the conflicting conclusions and citing those studies are one list item in the source, and the citation is the means of identifying the described studies. Treated as one rule, it is atomic.
- The check does not match the rule on citations. It flags only a conflicting study that is 'neither described nor cited'. A communication that describes a conflicting conclusion without citing the study would pass, although the source says 'The citations for any such studies should also be included.'
- Judgment is correct: 'scientifically sound' and 'same or similar hypotheses' require assessment. The escalation note covers this.
- The applies_when scope, the warning severity and the 'Section V, Q2' locator are appropriate.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028