Reprint's journal should have a public conflict-of-interest disclosure policy

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

Rule

A reprint shared by a firm should come from a journal managed by an organization that has a publicly stated policy regarding the disclosure of conflicts of interest or biases for all authors, contributors, and editors.

Check

Verify that the journal's managing organization has a publicly stated conflict-of-interest/bias disclosure policy covering authors, contributors, and editors. A violation is a reprint from a journal whose managing organization has no publicly stated conflict-of-interest/bias disclosure policy covering authors, contributors, and editors.

Escalate when

Assessing whether a stated policy is adequately public or complete can require judgment.

Where this comes from

Section V, Q4, item 1 (Reprints) · page 23. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…igital clinical practice resources that are included in an SIUU communication, in addition to the recommendations outlined in Q1, Q2, and Q3. 1. Reprints: When firms share SIUU communications that include one or more reprints, the reprints should be unaltered/unabridged because the sharing of unaltered/unabridged articles is less likely to introduce bias or result in the omission of material information. Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics: The article is published in a journal managed by an independent organization that has an editorial board composed of persons who have demonstrated expertise in the subject of the articles under review by the organization (through education or experience) and that has a publicly stated policy regarding the disclosure of conflicts of interest or biases for all authors, contributors, and editors The article is peer-reviewed by experts in the subject of the article, as established by education or experience The article is generally available (or the journal from which the article is taken is generally available) through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) where periodicals and reprints are sold or are accessible Article…

Open the original at page 23 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
- Q4 item 1 lists a publicly stated conflict-of-interest/bias disclosure policy as part of a characteristic FDA 'recommends' for articles shared as reprints; the rule text says 'should', but the title says 'must have', overstating a recommendation.
- The quote is a bare list item without its lead-in ('Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:'), so it does not show that this is a recommendation about reprints.
- The rule addresses only the disclosure policy, so it is atomic; judgment is defensible given 'publicly stated' and coverage of all authors, contributors, and editors.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The same Q4 item 1 characteristic continues '...and that has a publicly stated policy regarding the disclosure of conflicts of interest or biases for all authors, contributors, and editors'. The quote runs through the complete item and supports the rule directly.
- The quote also contains the editorial-board clause, but the rule statement and check address only the COI/bias disclosure policy, so the rule is atomic and distinct from US-SCI-036.
- Recommendation language ('should') is preserved. Judgment is defensible: whether a policy is publicly stated and covers all three groups can take assessment. Scope, severity and locator are correct.

Nearby rules

US-SCI-019 US-MIS-032 US-SCI-018 US-SCI-019 US-SCI-020 US-SCI-021 US-SCI-036