Continuing to share a retracted source publication is inconsistent with FDA's recommendation

AI-verifiedblockerFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

FDA does not consider it consistent with its recommendation that firms take existing scientific knowledge into account for a firm to continue sharing an SIUU communication whose source publication has been retracted by the publisher (for example, because the findings are no longer trusted following discovery of scientific misconduct or error).

Check

Check the source publication's current status with the publisher/journal. A finding is continued dissemination of a communication built on a source publication that the publisher has retracted.

Where this comes from

Section V, Q1, item 2 · page 17. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…dance. If, for example, a firm were to disseminate a source publication that predated the scientific knowledge that Medical Product X causes a severe adverse event in a specific population of women (e.g., severe birth defects when administered to pregnant women) and the source publication suggested Medical Product X was an appropriate treatment for all women, that would not be consistent with this recommendation. In addition, it would not be consistent with this recommendation that firms take into account existing scientific knowledge if a firm continues to share an SIUU communication that has been retracted by the publisher because, for example, findings from the study are no longer trusted due to discovery of scientific misconduct or error. Additionally, in a case where understanding of a disease has advanced and shown that certain outcome measures used in studies do not reflect an effect on the disease, sharing source publications that are based on studies that used those outcome measures would not be consistent with the recommendation that firms take into account existing scientific knowledge when determining whether a source publication should be in…

Open the original at page 17 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 source does establish the substance: the quoted sentence says it 'would not be consistent with this recommendation ... if a firm continues to share an SIUU communication that has been retracted by the publisher'. So the subject matter is supported.
- But the rule statement is written as a prohibition ('A firm must not continue sharing...'), which converts a non-binding FDA recommendation into an obligation. The source's operative language is consistency with a recommendation and with the enforcement policy, not a ban. This is the classic overstatement failure and must be fixed.
- Authority field 'guidance' is itself correct — the rule does not claim to restate a regulation — so the fault is in the rule text, not the authority classification. This is not a case of a guidance merely restating statute or regulation, so it is fixable rather than reject.
- Atomic: a single checkable condition (retraction status of the source publication).
- Deterministic is defensible: retraction by the publisher is a binary status with no element of impression, adequacy, prominence or balance; the reviewer checks the journal's current record.
- Severity 'blocker' is defensible given the source's rationale (findings 'no longer trusted due to discovery of scientific misconduct or error') and the accompanying recommendation that a firm remove such a communication from the internet where it can.
- The quote is a complete sentence and the locator 'Section V, Q1, item 2' is right. applies_when is appropriate and inherited from the guidance's HCP/SIUU scope.
- Minor: the rule says the 'source publication has been retracted' while the quote says the 'SIUU communication ... has been retracted by the publisher'; the rule's reading is the sensible one but the rule text should make clear it is the source publication whose retraction is at issue.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Q1 item 2 states that 'it would not be consistent with this recommendation that firms take into account existing scientific knowledge if a firm continues to share an SIUU communication that has been retracted by the publisher'; the title and rule text keep the source's own framing ('inconsistent with FDA's recommendation') rather than converting it into an obligation.
- The quote is a complete sentence. Reading 'an SIUU communication that has been retracted by the publisher' as the retracted source publication is the only sensible reading, since publishers retract publications.
- Whether a publication has been retracted is a factual status check, so deterministic is correct.
- Blocker severity is defensible for continued dissemination of retracted science even under guidance authority; locator Section V, Q1, item 2 is correct.

Nearby rules

US-SUB-013