Respond publicly to an off-label request only when it names the firm's own product

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

Rule

A firm should respond to a public unsolicited off-label request only when the request pertains specifically to the firm's own named product, not solely to a competitor's product.

Check

Check that the public request being answered names or specifically concerns the firm's own product rather than only a competitor's product or a generic/unnamed drug class question.

Escalate when

Whether the original question was specific enough to the firm's named product is unclear.

Where this comes from

Section VI, Recommendation 1 · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available). FDA makes the following recommendations to a firm that chooses to respond to public unsolicited requests for off-label information about its product(s), including those encountered through emerging electronic media. 1. If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product). The level of specificity of the question posed in a public forum is important in determining the appropriateness of a firm responding to the unsolicited request. Example 13: An individual poses the specific question “Can Drug/Device X be used for Condition Y” in a public forum (and this question is not prompted by or on behalf of the firm). It may be appropriate for the firm to respond as outlined below becau…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported by Section VI, Recommendation 1, lines 375-377, with Example 13 (lines 382-390) confirming that a firm should not respond to a non-specific question such as 'What drug/device can be used for Condition Y'.
- The rule keeps 'should' and preserves both halves of the source's condition (pertains specifically to the firm's own named product; not solely about a competitor's product). It is a single condition on responding, not two bundled obligations.
- The limitation to public requests cannot be expressed in the fixed applies_when vocabulary but is stated plainly in the title, rule text and check, which is acceptable.
- Judgment is correct - whether a public question is specific enough to the firm's named product is the evaluative call the source itself highlights at lines 379-380.
- Authority guidance, locator and warning severity are correct; 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 VI Recommendation 1 verbatim and includes its conditional lead-in, so it is self-contained. The rule keeps 'should' and the 'not solely about a competitor's product' qualifier.
- Example 13 supports treating a non-specific 'What drug/device can be used for Condition Y' question as out of scope in the Check.
- Deciding whether a question is specific enough is a judgment call. Severity and locator are correct.