Rules/misleading presentation/US-MIS-033

Do not share CPGs that misrepresent or overstate their underlying findings

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

Rule

A CPG should not be shared in an SIUU communication if it misrepresents or overstates the findings of a study or analysis in light of that study's or analysis's limitations.

Check

Compare the CPG's characterization of underlying evidence against that evidence's actual limitations. A violation is a CPG that overstates or misrepresents the evidence it relies on.

Escalate when

Whether a CPG's characterization amounts to overstatement is a matter of scientific judgment.

Where this comes from

Section V, Q4, item 2.a (CPGs) · page 25. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…rest The CPG includes ratings of the recommendations to reflect the quality and strength of evidence that supports each recommendation The CPG is revised when important new evidence warrants modifications of current recommendations The CPG is generally available through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) where CPGs are sold or are accessible CPGs that misrepresent or overstate findings from a study or analysis in light of the limitations of such study or analysis would not fall within the enforcement policy outlined in this guidance. One helpful resource when considering whether a particular CPG is appropriate to be included in an SIUU communication is the National Academy of Medicine (NAM) standards for CPG “trustworthiness.” CPGs that are consistent with the NAM standards would also be consistent with the recommendations in this guidance about the characteristics that CPGs should have. The NAM standards recommend that CPGs (…

Open the original at page 25 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 sentence appearing verbatim in Q4, item 2.a (Specific Recommendations for CPGs), immediately after the list of characteristics FDA recommends a CPG have. Read in context it states that a misrepresenting/overstating CPG falls outside the enforcement policy, and the rule renders that as 'a CPG should not be shared in an SIUU communication if...' — the correct practical reading, not a strengthening.
- Modality is preserved: the rule says 'should not', matching the non-binding recommendation character of the guidance. No obligation language is asserted.
- Atomic: a single condition (the CPG misrepresents or overstates findings in light of the study's limitations) on a single artifact type.
- Determinism 'judgment' is right — whether a characterization overstates findings 'in light of the limitations' turns on scientific interpretation, not presence/absence.
- Authority 'guidance' matches the source document and the rule claims nothing more; it does not restate a statute or regulation that the guidance merely quotes.
- applies_when (hcp audience, unapproved-use-scientific basis) tracks the guidance's scope: SIUU communications from firms to HCPs. The limit to CPGs is carried in the rule text, which the scoping vocabulary cannot express.
- Severity 'blocker' is defensible: content outside the enforcement policy exposes the firm to misbranding/intended-use consequences.
- Violable: a reviewer can find a CPG that overstates its evidence base.

Nearby rules

US-SCI-024 US-SCI-025 US-SCI-026 US-SCI-027