Send non-public unsolicited-request response only to the requestor, privately

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

Rule

A response to a non-public unsolicited request for off-label information should go only to the individual who made the request, as a private, one-on-one communication.

Check

Confirm the detailed off-label response was sent solely to the requestor and not copied, posted, or otherwise made available to any other person.

Escalate when

The distribution list or channel for the response is unclear, or the response appears to have been shared beyond the original requestor.

Where this comes from

Section V, Recommendation 1 · page 10. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…or through a firm-controlled website that enables individuals to privately submit a request directly to the firm so that the request is not available to the public. FDA makes the following recommendations to a firm that is responding to a non-public unsolicited request for off-label information about its product that was specifically directed to the firm privately through a one-on-one communication. 1. Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication. 2. Information distributed in response to an unsolicited request should be tailored to answer only the specific question(s) asked. A firm should ensure that all pertinent background data are obtained to be able to determine what information is being requested before providing a response. If an unsolicited question is broad in nature, the firm should appropriately narrow the question. In other words, the level o…

Open the original at page 10 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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Directly supported by Section V, Recommendation 1, lines 237-238, and reinforced by lines 210-213, which say the final response with the requested off-label information should go only to the specific individual who requested it as a private, one-on-one communication.
- The rule keeps 'should' and narrows itself to non-public unsolicited requests, matching the Section V heading; it does not extend the recommendation beyond the source.
- One requirement - private delivery to the requestor alone. Atomic.
- Judgment is acceptable: the check turns on reconstructing who actually received the response (distribution list, channel, onward sharing), which is not settled by presence or a literal match in the piece under review, and the escalate-when covers the unclear case.
- Authority guidance, Section V locator and warning severity are right; the quote is a complete sentence.
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 Section V Recommendation 1 verbatim and is a complete sentence with its own subject; the Section V lead-in limits it to non-public unsolicited requests, and the rule text states that limit ('non-public unsolicited request'), which the fixed applies_when vocabulary cannot express.
- The rule keeps 'should', so it does not overstate this non-binding guidance; the imperative title names the action without asserting an obligation.
- Section IV independently says the final response should go only to the requestor as a private one-on-one communication, which is consistent with the rule.
- Deciding whether the response went only to the requestor depends on the distribution evidence, so 'judgment' is defensible. Severity 'warning' and the locator are correct.