Response to an unsolicited request should be tailored to the specific question asked

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

Information distributed privately in response to an unsolicited request for off-label information should answer only the specific question(s) actually asked, not a broader set of off-label uses or claims. Known or suspected risk information about other diseases or conditions that is relevant to the requested use should nonetheless be provided.

Check

Compare the scope of the response against the scope of the original request; flag efficacy or use information that goes beyond the specific disease, condition, population, or question raised, but do not flag relevant risk information about other diseases or conditions.

Escalate when

It is unclear whether content in the response was actually responsive to the original question or was added beyond its scope.

Where this comes from

Section V, Recommendation 2 · page 10. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…wing 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 of specificity of the question posed is important to ensure that the firm’s response is tailored to the request. Example 12: An in…

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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported by Section V, Recommendation 2, lines 240-241, elaborated at lines 243-252: the response should be tailored to answer only the specific question(s) asked, and Example 12 confirms the narrow reading.
- The rule preserves 'should' and adds only a gloss ('not a broader set of off-label uses or claims') that follows from the source's own tailoring discussion; it does not contradict the risk carve-out at lines 253-258, which is captured elsewhere.
- Single requirement - scope of the response matches scope of the request. Atomic.
- Judgment is correct: comparing the scope of the response against the scope of the request is an evaluative fit question, not a literal match.
- Authority guidance, locator and severity are appropriate; the quote is a complete sentence.
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 Section V Recommendation 2 verbatim, is a complete sentence, and supports tailoring the response to the specific question asked.
- The Check tells reviewers to flag any content that goes beyond 'the specific disease, condition, population, or question raised'. The source makes an explicit exception: 'if there is information about known or suspected risks associated with other diseases or conditions that is also relevant to the disease or condition for which information was requested, the firm should provide such information' (see the Drug X arthritis/fetal-harm example). As written, the check would flag risk information that the guidance says the firm should include, so it is broader than the source.
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 the complete sentence of Section V Recommendation 2 and supports the rule; the risk-information carve-out is correctly drawn from the Example 12 follow-on paragraph.
- The title 'Tailor unsolicited-request response to the specific question asked' is a bare command for a guidance 'should'.
- The rule text's second sentence ('...and should not be flagged as such') is a reviewer instruction, not a statement of the rule; it belongs in the Check, which already says it.
- Section V applies to private responses to non-public unsolicited off-label requests; the rule text does not carry that limit.
- Judgment is correct: scope of responsiveness is an assessment.
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 the whole heading sentence of Section V, Recommendation 2, and it supports the core rule: a response to a non-public unsolicited request should be tailored to answer only the specific question(s) asked. The 'should' language is kept, and 'judgment' is correct because scope-matching needs interpretation.
- The rule's second sentence ('Known or suspected risk information about other diseases or conditions that is relevant to the requested use should nonetheless be provided') is a separate, affirmative recommendation. It comes from a later paragraph ('However, if there is information about known or suspected risks ... the firm should provide such information'), which the quote does not cover. That bundles two independently checkable recommendations: do not go beyond the question, and do include relevant cross-condition risk information. The check tests only the first, and treats the second only as a carve-out that should not be flagged.
- The source's risk paragraph works as a limit on tailoring, so keeping it as a carve-out in this rule is appropriate. Phrased as an affirmative duty with no supporting quote and no check, it is not.
- The source's example also uses 'Generally', so tailoring is a general recommendation, not an absolute one. The rule's 'answer only' is still acceptable because it tracks the quoted sentence.