Disclose authors/contributors with firm financial relationships

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

FDA recommends that an SIUU communication identify, among the other recommended items, any author, editor, or other contributor to an included publication who, at the time of contributing, was a firm employee or consultant or received compensation from the firm, to the extent a firm acting reasonably would know of such relationship.

Check

Cross-check contributor names against known firm employees, consultants, and compensation recipients. A violation is a known financial relationship between a contributor and the firm that is not disclosed.

Escalate when

It is unclear whether the firm 'acting reasonably' would have known of a particular contributor's relationship to the firm.

Where this comes from

Section V, Q2 · page 19. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: FDA recommends that firms include all of the following information as part of SIUU communications:

…t A statement describing any serious, life-threatening, or fatal risks posed by the medical product that are in the FDA-required labeling for the medical product or known by the firm and that are relevant to the unapproved use(s) If a risk evaluation and mitigation strategy (REMS) has been established under 21 U.S.C. 355-1, the statement should disclose that fact and should describe the goal(s) of the REMS A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the publication, to the extent a firm acting reasonably would know of such relationship In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of: All material aspects of study design, methodology, and results. https://doi.org/10.1136/bmj.326.7400.1167 </u> (reviewing 30 studies finding th…

Open the original at page 19 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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported by the Q2 bullet on identifying authors, editors and other contributors who were employees of, consultants to, or compensated by the firm at the time of contributing, 'to the extent a firm acting reasonably would know of such relationship'; the rule restates this accurately and keeps the 'should' force.
- The quote is a list item that drops the stem 'FDA recommends that firms include all of the following information as part of SIUU communications', so on its own it reads as a sentence fragment rather than a recommendation.
- Determinism is mislabelled as 'deterministic'. The trigger is not settled by presence/absence in the document: it depends on facts outside the piece (who was compensated) filtered through a reasonableness standard ('a firm acting reasonably would know'). The rule's own escalation clause concedes this is a judgment call.
- Severity 'warning', authority 'guidance', audience/basis scoping and the Q2 locator are all correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V Q2 recommends 'A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the publication, to the extent a firm acting reasonably would know of such relationship'. The rule captures this item.
- The rule changes the knowledge standard from 'to the extent a firm acting reasonably would know of such relationship' to 'to the extent the firm could reasonably know of the relationship'. 'Could reasonably know' covers relationships the firm might have found out about. The source covers only relationships a reasonable firm would know of. That makes the rule broader than the source. The Escalate section quotes the correct standard, so the rule contradicts its own escalation trigger.
- Recommendation language is kept and authority is guidance. 'judgment' is correct because the reasonable-knowledge standard needs an assessment. Scope, severity and locator are correct.
- The rule's quote is only the list's lead-in sentence, which several rules share. The quote therefore does not contain the item that establishes this rule. The verifier contract now provides a `lead_in` field for a list item that is not adjacent to its lead-in, so the quote can and should be the item itself.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim a Q2 list item. The rule body faithfully keeps the 'to the extent a firm acting reasonably would know' limit and frames it as a recommendation.
- Judgment is correct because the item turns on what a reasonably acting firm would know.
- The quote is a bare list item with no subject. Its introducing sentence is not adjacent (several list items and footnote text come between), and there is no lead_in.
- The title 'Disclose authors/contributors with firm financial relationships' is a bare command that states a recommendation as an obligation.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim a Q2 list item under the given lead_in. The rule statement matches it faithfully, including the 'to the extent a firm acting reasonably would know' limit, and says 'FDA recommends'.
- The title 'Disclose authors/contributors with firm financial relationships' is a bare command, which turns a guidance recommendation into an order.
- Judgment is correct because of the reasonable-knowledge standard, and the escalation on that point fits. applies_when and the locator are correct.

Nearby rules

US-DISC-005 US-DISC-007 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016