Include representative publications reaching contrary conclusions when a source's conclusions are disputed

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

If the conclusions of a disseminated article or text have been specifically called into question by other publications, the firm should also disseminate representative publications reaching contrary or different conclusions about the use at issue.

Check

Check whether a cited article's disputed conclusions are accompanied by representative contrary literature; flag one-sided citation where known rebuttal literature exists.

Escalate when

It is unclear whether contrary literature exists or is representative of the scientific dispute.

Where this comes from

Section V, Recommendation 3 · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…X during pregnancy in patients with diabetes). 3. Information distributed in response to an unsolicited request should be truthful, non- misleading, accurate, and balanced. A response should provide non-biased information or data relating to the particular off-label use that is the subject of the request, including applicable data that are not supportive or that cast doubt on the safety or efficacy of that use. For example, when conclusions of articles or texts that are disseminated have been specifically called into question by other articles or texts, a firm should disseminate representative publications that reach contrary or different conclusions regarding the use at issue. The response should include complete copies of scientific reprints, technical literature, or other scientific and medical information responsive to the request, not just summary documents or abstracts prepared by the firm. The response can include unpublished data on file if they are responsive to the specific request (either supporting or casting doubt on the safety or efficacy of the off-label use). However, t…

Open the original at page 11 on fda.gov ↗Read our full copy →

Document: FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)
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: 8ab6bfda34ad39a70987805b…

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

Applies when

Basisunsolicited-request

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V, Recommendation 3 (lines 265-268) states the requirement directly: when disseminated conclusions have been specifically called into question by other articles or texts, a firm should disseminate representative publications reaching contrary or different conclusions. Although the sentence is introduced by 'For example', it is itself a normative recommendation, not an illustration of a definition, and the rule does not go beyond it.
- The rule keeps the source's 'should' and its conditional trigger (conclusions specifically called into question), so it is not stronger or broader than the source.
- One requirement: include representative contrary publications. Atomic.
- Judgment is correct - whether rebuttal literature exists and whether the selection is 'representative' of the dispute turns on scientific evaluation, not literal presence.
- Authority guidance, severity warning, and the Section V locator are all defensible; the quote is a complete sentence.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from Section V, Recommendation 3. It opens with 'For example', but it is still a direct 'a firm should' statement that makes Recommendation 3's non-biased-information principle concrete. It is not a hypothetical fact pattern, so it supports a guidance-level recommendation.
- The rule keeps 'should', and its conditional trigger (conclusions specifically called into question by other articles or texts) matches the source exactly.
- The rule is correctly marked judgment. Whether contrary literature exists and is representative is a scientific judgment, and the escalation condition covers this.
- The rule is atomic, and applies_when 'unsolicited-request' matches the scope of Section V.

Nearby rules

US-MIS-026 US-SUB-009 US-SUB-010