Reprinted article should be peer-reviewed by subject-matter experts

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

Rule

A reprint shared by a firm should be an article that was peer-reviewed by experts in the article's subject matter.

Check

Confirm the article's peer-review status and reviewer qualifications. A violation is sharing a non-peer-reviewed article as a reprint, or one reviewed by persons without demonstrated subject-matter expertise.

Escalate when

Whether the article's peer reviewers are experts in its subject area, as established by education or experience, may not be verifiable from the publication and 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.

This rule is one item of a list. The list is introduced by: Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:

… 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 Articles that misrepresent or overstate findings from a study or analysis in light of the limitations of such study or anal…

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
- Supported: the bullet in Q4 item 1 lists peer review by subject-matter experts among the characteristics FDA recommends for articles shared as reprints.
- Not overstated; modality and authority match the guidance.
- Single requirement, so atomic.
- 'deterministic' is wrong. The requirement is not merely that the article went through peer review (which would be a presence/absence fact about the journal) but that the peer reviewers were 'experts in the subject of the article, as established by education or experience'. The rule's own check instructs the reviewer to confirm 'reviewer qualifications', which is an adequacy assessment and is routinely not verifiable by literal match since reviewers are usually anonymous. The sibling rule US-SCI-019 correctly labels the same kind of expertise assessment 'judgment'.
- Locator, applies_when and 'warning' severity are all defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source lists peer review by subject experts as a characteristic FDA 'recommends' for articles shared as reprints; the rule text says 'should', but the title says 'must be peer-reviewed', overstating a non-binding recommendation.
- The quote 'The article is peer-reviewed by experts ...' 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:'); standing alone it reads as a factual description, not a recommendation about reprints.
- Judgment is correct: reviewer expertise 'as established by education or experience' cannot be settled by literal match.
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 the second reprint characteristic in Q4 item 1. The rule and title use 'should', which is faithful.
- Judgment is correct because reviewer expertise is rarely verifiable, as the escalation note says.
- The quote is a bare list item. Its introducing sentence ('Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:') is separated from it by the long first characteristic, and there is no lead_in. Read alone, the quote looks like a statement of fact, not a recommendation.
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote 'The article is peer-reviewed by experts in the subject of the article, as established by education or experience' is a verbatim, complete list item from Section V, Q4, item 1 (Reprints).
- The lead_in 'Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:' is verbatim and introduces the item. Together they support the rule.
- The title and rule use 'should', which matches the non-binding recommendation. Nothing is overstated.
- The rule is a single characteristic (peer review by subject-matter experts), so it is atomic. It is separate from the journal/editorial-board and general-availability items in the same list.
- Judgment is correct: whether reviewers are subject-matter experts turns on an assessment that often cannot be verified. The escalation note reflects this.
- The applies_when scope (hcp, unapproved-use-scientific) matches the SIUU context of Q4. Severity warning is defensible. The locator is correct.
- Minor, not required: the check's word 'violation' is strong for a guidance recommendation. The rule statement itself keeps 'should'.

Nearby rules

US-MIS-032 US-SCI-018 US-SCI-019 US-SCI-021 US-SCI-036 US-SCI-037