Rules/misleading presentation/US-MIS-038

Do not present source publication information out of context

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

Rule

A firm-generated presentation should not present excerpts, quotes, paraphrases, or conclusions from the source publication out of context.

Check

Compare each excerpt/quote/paraphrase/conclusion used in the presentation against its surrounding context in the source publication. A violation is information presented in a way that misrepresents its original context or meaning.

Escalate when

Whether something is 'out of context' is a matter of interpretation.

Where this comes from

Section V, Q5 (prohibited practices) · page 29. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…tion of the statements in the source publication, without attributing that statement expressly to the source publication and without immediately following it with the statement identifying any authors, editors, or other contributors to the source publication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the source publication Present information (e.g., excerpts, quotes, paraphrases, conclusions) from the source publication out of context Use statistical analyses or techniques to indicate clinical significance or validity of a finding not supported by the data or information in the source publication Use presentational elements to obscure or distort the scientific content, such as by using textual features and graphic design elements to emphasize only positive information or distract attention from unfavorable information, or by using tables or…

Open the original at page 29 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

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
- The quote is a complete enumerated item from the Q5 'should not... do any of the following' list, reproduced verbatim including its parenthetical, and the rule restores the elided subject.
- Not overstated: scope (firm-generated presentations) and modality ('should not') both match the source.
- Atomic: one failure mode — out-of-context presentation of source-publication material. The parenthetical list (excerpts, quotes, paraphrases, conclusions) is illustrative of the covered material, not a set of separate requirements.
- Determinism 'judgment' is right: 'out of context' turns on how the excerpt reads against its surroundings.
- Authority 'guidance' matches the source document.
- applies_when is justified for SIUU communications to HCPs; the firm-generated-presentation limit is carried in the rule text.
- Severity 'blocker' is defensible — out-of-context use of source material directly undermines the truthful and non-misleading condition of the enforcement policy.

Nearby rules

US-MIS-036 US-MIS-037 US-MIS-039 US-MIS-040