Firm-generated presentation should follow safety claims with contributor disclosure

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

Rule

To be truthful and non-misleading, a firm-generated presentation should not, for example, present a conclusion or representation about safety or effectiveness for the unapproved use without immediately following it with the statement identifying any authors, editors, or other contributors to the source publication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the source publication.

Check

For each safety/effectiveness conclusion presented from a source publication whose authors, editors, or other contributors were employees of, consultants to, or compensated by the firm, confirm it is immediately followed by the contributor-relationship disclosure identifying those individuals. A violation is such a conclusion presented without the adjacent contributor disclosure.

Where this comes from

Section V, Q5 · page 29. 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: Additionally, to ensure a firm-generated presentation is truthful and non-misleading, the firm-generated presentation should not, for example, do any of the following:

…xample, do any of the following: Imply that the study, analysis, or underlying data or information from the source publication represents larger or more-general experience with the medical product than it actually does Include representations or suggestions about the safety or effectiveness of the medical product for the unapproved use(s) that are not consistent with the source publication Present conclusions or representations about safety or effectiveness for the unapproved use, even if they are an accurate reflection of the statements in the source publication, without attributing that statement expressly to the source publication and without immediately following it with the statement identifying any authors, editors, or other contributors to the source publication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the source publication Present information (e.g., excerpts, quotes, paraphrases, conclusions) from the source publication out of context Use statistical analyses or techniques to indicate clinical significance or validity of a finding not supported by the data or information in the source publication Use presentational elements to obscure or distort the scientific content, such as by using textual features and graphic design elem…

Open the original at page 29 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. Not yet independently verified — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim the third item of the Q5 'should not, for example, do any of the following' list. The rule body correctly frames it as 'should not' and takes only the immediately-following contributor-disclosure half, which is an acceptable atomic split from the attribution half.
- The quote is a bare list item. Its introducing sentence is not adjacent (two list items come between), and there is no lead_in.
- The title 'Follow attributed safety/effectiveness conclusions with the contributor-relationship disclosure' is a bare command that states a recommendation as an obligation.
- The check calls every conclusion without the adjacent disclosure a violation. But the disclosure only has content where a contributor had a firm relationship (per Q2, one a firm acting reasonably would know of), and the check does not say this.
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 a complete list item and is read with its verbatim lead-in ('the firm-generated presentation should not, for example, do any of the following:'). Together they support a recommendation that a firm-generated presentation not present safety or effectiveness conclusions from a source publication without immediately following them with a statement identifying firm-affiliated or firm-compensated authors, editors, or contributors.
- The rule text keeps the guidance's non-binding force ('should not, for example') and limits itself to firm-generated presentations. It does not recast the recommendation as an obligation.
- The source item joins two conditions: express attribution to the source publication, and the adjacent contributor disclosure. The rule checks only the disclosure half. That is a legitimate atomic slice, and the rule and check do not misstate it.
- Whether a disclosure identifying firm-affiliated contributors immediately follows each conclusion is a presence-and-adjacency test, so 'deterministic' is defensible. 'Warning' severity suits a guidance-derived recommendation. The locator (Section V, Q5) matches the source.
- The title says 'safety claims', which is narrower than the source and the rule body. Both cover conclusions or representations about safety OR effectiveness. A reviewer reading only the title could miss effectiveness conclusions.

Nearby rules

US-DISC-013 US-DISC-012 US-DISC-013 US-DISC-014 US-SCI-032 US-SCI-033 US-SCI-034 US-SCI-035 US-SCI-038