Rules/misleading presentation/US-MIS-026

Response should include complete reprints and literature, not just firm summaries

AI-verifiedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

Information distributed privately in response to an unsolicited request for off-label information should include complete copies of scientific reprints, technical literature, or other scientific and medical information responsive to the request; a summary or abstract prepared by the firm should not replace it.

Check

Check whether any cited reprint, technical literature, or other scientific or medical information responsive to the request is represented only by a firm-written summary or abstract rather than the complete original material.

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.

…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 The response can include unpublished data on file if they are responsive to the specific request (either supporting or casting doubt on the safety or efficacy of the off-label use).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, to the greatest extent possible, a firm should rely on published peer-reviewed journal articles, medical texts, or data derived from independent sources. To the extent the response consists of published reprints from journal…

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
- Directly supported by Section V, Recommendation 3, lines 268-270: the response should include complete copies of reprints, technical literature or other responsive scientific and medical information, not just firm-prepared summaries or abstracts.
- The rule is if anything slightly narrower than the source (it conditions on the response relying on reprints or literature), so it is not overstated; it preserves 'should'.
- Single requirement: complete copy rather than a firm-prepared summary. Atomic.
- Deterministic is correct - whether the enclosed item is the complete original document or a firm-written summary/abstract is settled by inspection, not by impression or adequacy.
- Authority guidance, locator and severity are correct; the quote is a complete sentence.
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 a complete sentence from Section V, Recommendation 3, and the rule text and check are faithful. The source says the response should include complete copies 'not just summary documents or abstracts prepared by the firm'.
- The title reads 'Provide complete reprints and literature, not firm-prepared summaries or abstracts'. This drops 'just', so it reads as excluding firm-prepared summaries. The source only says summaries cannot substitute for the full copies, and it does not prohibit including them. The title is therefore broader than the source.
- The deterministic flag is acceptable, because whether a complete copy is present settles it. The rule is atomic.
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 a complete sentence from Section V Recommendation 3 and supports the rule.
- The title 'Provide complete reprints and literature, not just firm-prepared summaries or abstracts' turns 'should include' into a bare command.
- The rule text says a firm summary or abstract 'cannot replace' the complete copy; 'cannot' is stronger than the source's 'should include ... not just summary documents or abstracts'.
- The rule text narrows the scope to 'scientific reprints or technical literature', dropping 'or other scientific and medical information responsive to the request'.
- Deterministic is acceptable: whether a complete copy, rather than only a firm summary or abstract, is included is a presence check.
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 whole sentence from Section V, Recommendation 3 (non-public unsolicited requests). The rule restates it faithfully: the response should include complete copies of responsive reprints, literature, or other scientific and medical information, and should not rely only on firm-prepared summaries or abstracts.
- The rule keeps the recommendation language ('should'). 'Privately' correctly carries the Section V limit to non-public, one-on-one requests. The applies_when basis 'unsolicited-request' matches the source.
- The check asks whether the complete original material is present or only a firm-written summary. That is a presence/absence test, so 'deterministic' is correct. It is a single requirement.
- 'Warning' severity is defensible for a guidance recommendation, and the locator is correct. The category is inherited and is not revised here.

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