Disclose unfavorable or inconsistent findings, not just favorable results

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

Rule

FDA recommends that a CFL promotional communication disclose unfavorable or inconsistent findings from the data it relies on, clearly and prominently, rather than selectively presenting only favorable results.

Check

If a study evaluated multiple endpoints or outcomes, check whether unfavorable or non-significant results are disclosed alongside favorable ones. A violation looks like a piece citing only the endpoints on which the product succeeded.

Escalate when

It is unclear whether an omitted finding is 'inconsistent' enough with the presented claim to require disclosure.

Where this comes from

Q.8/A.8, bullet 2 · page 17. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ences to accurately interpret the information presented (e.g. type of study, study objectives, product dosage/use regimens, controls used, patient population studied) from any studies relied on should be clearly and prominently disclosed in firms’ CFL promotional communications, and material limitations related to the study design, methodology, and results should also be disclosed in a clear and prominent manner. The CFL promotional communication should accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. For example, if a firm presents efficacy results from a postmarketing study of its product that evaluated the effect of the product on two different endpoints, such as overall survival and progression-free survival, and the product failed to demonstrate an effect on one of these two endpoints, the firm should clearly and prominently disclose this in the CFL Contains Nonbinding Recommendations …

Open the original at page 17 on fda.gov ↗Read our full copy →

Document: FDA guidance: Medical Product Communications that Are Consistent With the FDA-Required Labeling – 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: 1a18b7f242bfbbf897f198df…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Naturepromotional

Basisconsistent-with-labeling

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
- Supported by A.8 bullet 2, including the worked illustration FDA gives in the same bullet: where a postmarketing study evaluated overall survival and progression-free survival and the product failed on one endpoint, 'the firm should clearly and prominently disclose this in the CFL promotional communication, rather than selectively presenting only the positive efficacy results.' The Check mirrors that illustration accurately.
- Not atomic: the rule statement bundles two independently checkable requirements — (a) accurately characterize and contextualize the relevant information, and (b) disclose unfavorable or inconsistent findings rather than presenting only favorable results. Only (b) is covered by the title, the Check and the Escalate condition, and (a) duplicates US-DISC-001 in this same packet. A reviewer applying this rule cannot tell which failure it is being asked to find.
- Scope mismatch: the rule statement is properly scoped to 'a CFL promotional communication,' but applies_when has only "promotional" with no basis limiter, so the rule as configured fires beyond the scope the guidance states for these recommendations ('applicable only to drug and device labeling and prescription drug and restricted device advertising that are consistent with the FDA-required labeling').
- 'Judgment' is correct — whether an omitted finding is unfavorable or inconsistent enough to require disclosure, and whether disclosure is clear and prominent, are not settled by presence/absence. 'Guidance' is correct. 'Blocker' is defensible for selective presentation of efficacy results, and the locator (bullet 2) is right.
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 the complete first sentence of Q.8/A.8 bullet 2 and establishes the disclosure of unfavorable or inconsistent findings.
- The rule's added qualifiers are supported by the immediately following text in the same bullet, which says the firm 'should clearly and prominently disclose this in the CFL promotional communication, rather than selectively presenting only the positive efficacy results' — so 'clearly and prominently' and 'rather than selectively presenting only favorable results' are not invented.
- Not overstated: stated as an FDA recommendation, scoped to CFL promotional communications as the guidance scopes its own recommendations.
- Atomic: the rule deliberately takes only the disclosure-of-unfavorable-findings requirement, leaving the broader 'accurately characterize and contextualize' duty to other rules.
- Determinism 'judgment' is correct (whether a finding is unfavorable/inconsistent enough to require disclosure, and whether disclosure is prominent). Authority 'guidance' matches the document; 'blocker' is defensible for selective presentation of efficacy data, and the locator and applies_when are right.