Rules/misleading presentation/US-MIS-040

Do not use presentational elements to obscure or distort scientific content

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

Rule

A firm-generated presentation should not use textual, graphic, or table/graph design elements that obscure or distort the scientific content — including emphasizing only favorable information, distracting from unfavorable information, or misrepresenting relationships/trends/differences/changes shown in the source data.

Check

Review typography, color, layout, and any tables/graphs for selective emphasis or visual distortion relative to the underlying data. A violation is design choices that make unfavorable information less noticeable or that misrepresent data relationships.

Escalate when

Whether a design choice crosses from legitimate emphasis into distortion is a judgment call.

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.

…onsultants 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 graphs to distort or misrepresent the relationships, trends, differences, or changes among the outcomes evaluated in the source publication Nevertheless, it is consistent with the enforcement policy outlined in this guidance for firm-generated presentations to use presentational elements and other communication techniques to help explain or illustrate the scientific content in an accurate way or to help ensure clear and prominent presentation of the recommended disclosures (see Q3). For instance, a communication that includes a firm-generated presentat…

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 list introduced by 'the firm-generated presentation should not, for example, do any of the following', reproduced verbatim including both 'such as' illustrations. The rule restores the elided subject ('a firm-generated presentation') and keeps the 'should not' modality.
- Not overstated: the rule stays inside the source's own examples (selective emphasis on positive information, distraction from unfavorable information, distorted tables/graphs) and does not extend to legitimate use of presentational elements, which the same passage expressly preserves ('it is consistent with the enforcement policy... to use presentational elements... to help explain or illustrate the scientific content in an accurate way').
- Atomic: a single prohibition — using presentational elements to obscure or distort scientific content — with the source's own illustrative means listed. The listed means are not independent requirements.
- Determinism 'judgment' is right: distinguishing emphasis from distortion turns on impression and balance.
- Authority 'guidance' matches the source document; no statutory or regulatory restatement.
- applies_when (hcp, unapproved-use-scientific) matches the guidance's scope; the firm-generated-presentation limit is carried in the rule text, which the scoping vocabulary cannot express.
- Severity 'blocker' is defensible: visual distortion of the underlying data defeats the truthful and non-misleading condition of the enforcement policy.

Nearby rules

US-MIS-036 US-MIS-037 US-MIS-038 US-MIS-039