Detailed off-label response should not be posted publicly in the same forum

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

Rule

Regardless of how broad the original public question's audience was, the firm should not make its detailed off-label response publicly available within that same forum.

Check

Check whether the detailed off-label information was ever posted, replied, or otherwise made publicly visible in the original public forum/thread.

Where this comes from

Section VI, Recommendation 2 · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…nformation regarding an off-label use of the firm’s product, the firm should provide a detailed response and maintain records following the parameters outlined in Section V of this draft guidance. Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off- label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum. For example, after the requestor has contacted the firm and provided a personal e-mail address to obtain an answer to the off-label question, the firm’s detailed off-label response, within the parameters outlined in Section V of this draft guidance, should be e-mailed to the requestor since this resulting communication will occur solely between the firm and the specific individual making the un…

Open the original at page 14 on fda.gov ↗Read our full copy →

Document: FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)
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: 8ab6bfda34ad39a70987805b…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Basisunsolicited-request

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 substance is supported: lines 410-412 say that regardless of how broad the original question's audience was, 'the firm should not make its detailed response with off-label information publicly available within the same forum', and lines 407-409 add that substantive off-label communication 'should occur solely between the firm and the individual who made the request'.
- The title overstates a non-binding draft-guidance recommendation: 'Never post...' states an absolute prohibition where the source says 'should not'. The rule body correctly says 'should not', so the defect is confined to the title but would be shown to reviewers as the rule's headline.
- The second clause of the rule statement ('the detailed response belongs only in a private, one-on-one follow-up') is supported by lines 405-409 but is not covered by the cited quote, so as drafted it asserts something the quote alone does not establish.
- Determinism 'deterministic' is acceptable: whether off-label detail was posted in the public thread is settled by inspecting the forum content, not by an impression judgment. Severity 'warning' and the Section VI Recommendation 2 locator are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from the Section VI Recommendation 2 discussion, and the rule restates it faithfully with 'should' and the same-forum limit.
- Whether detailed off-label information appears in the original public forum or thread is a presence/absence question, so 'deterministic' is defensible.
- Severity, locator and applies_when are appropriate.

Nearby rules

US-SCI-008 US-SCI-009 US-SCI-039