Rules/misleading presentation/US-MIS-031

Source publications that distort studies or include fraudulent data should not be disseminated

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

Rule

Disseminating a source publication that distorts a study or analysis (e.g., by inaccurately describing or reporting results) or that includes fraudulent data would not be consistent with FDA's enforcement policy, and such a publication should not be included in an SIUU communication.

Check

Compare the source publication's description of results against the underlying study/analysis for accuracy. A violation is any inaccurate description or reporting of results, or inclusion of data known to be fraudulent.

Escalate when

Suspected inaccuracy or fraud cannot be confirmed without access to the underlying raw data or a retraction notice.

Where this comes from

Section V, Q1, item 1 · page 16. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ation (see <u> http://www.ich.org/about/vision.html </u> for more information); and International Organization for Standardization (IOS), an international standards development organization (see <u> http://www.iso.org/iso/home.html </u> for more information). Contains Nonbinding Recommendations Not for Current Implementation—see PRA statement in section VI. effect of the medical product. Further, disseminating source publications that distort studies or analyses (e.g., by inaccurately describing or reporting results) or that include fraudulent data would not be consistent with the enforcement policy outlined in this guidance and may also violate provisions of the FDA Authorities, such as section 502(a) of the FD&C Act. For human and animal drugs, randomized, double-blind, concurrently controlled superiority trials are usually regarded as the most rigorous design and therefore the most likely to provide scientifically sound information. However, other studies may also be scientifically sound when adequately designed and conducted (e.g., data sources are reliable and relevant, protocols and statistical analysis plans are finalize…

Open the original at page 16 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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from the Q1 discussion and supports the substance: disseminating source publications that distort studies or analyses or that include fraudulent data would not be consistent with the guidance's enforcement policy.
- The rule overstates it. 'must not be disseminated' is an absolute obligation, while the source says only that such dissemination 'would not be consistent with the enforcement policy outlined in this guidance and may also violate' the FD&C Act — a statement about falling outside an enforcement policy plus a hedged 'may also violate', not a prohibition the guidance itself imposes.
- This is not a case for rejection as 'belongs to' section 502(a): the rule is drawn from the guidance's own enforcement-policy statement, and the 502(a) reference in the quote is ancillary rather than the rule's basis. But the rule must not borrow that statute's force.
- Determinism 'judgment' is correct (distortion and fraud turn on comparison against the underlying study and on scientific judgment, as the escalation clause says). Severity 'blocker' is defensible for fraudulent or distorted data; authority 'guidance' and the Q1 item 1 locator are correct.
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 in Section V, Q1, item 1: disseminating source publications that distort studies or analyses or include fraudulent data 'would not be consistent with the enforcement policy outlined in this guidance and may also violate provisions of the FDA Authorities'. The rule restates this.
- The rule text adds 'should not be included in an SIUU communication'. That follows from the Q1 context, which asks whether a source publication is appropriate to include and uses 'should not be included' for unreliable studies. It is recommendation-level and not overstated. The rule does not claim a statutory violation.
- Distortion and fraud turn on judgment and often on access to underlying data, so 'judgment' is correct, and the Escalate trigger covers the data-access problem. 'blocker' is defensible because the source says this conduct takes the communication outside the enforcement policy and may violate section 502(a). The locator is correct.

Nearby rules

US-SUB-012