Firm representatives should disclose their firm affiliation in public responses

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

Rule

A representative who posts a public response to an unsolicited off-label request should clearly disclose their affiliation with the firm.

Check

Check that the public response identifies the responder as a representative of the specific firm.

Where this comes from

Section VI, Recommendation 3 · page 15. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…irm 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to the off-label question, the firm’s detailed off-label response, within the parameters outlined in Section V of this draft guidance, should be e-mailed to the requestor since this resulting communication will occur solely between the firm and the specific individual making the unsolicited request for the off-label information. 3. Representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a particular firm. FDA recommends that a representative who responds to a public request clearly disclose in his/her public response that he/she is a particular firm’s representative and inform the requestor of the name of the firm representative or department to contact should the individual choose to follow up directly with the firm in a non-public forum for detailed information about the unsolicited request for off-label infor…

Open the original at page 15 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 rule statement and check track Section VI, Recommendation 3 faithfully: a representative giving a public response should disclose that he/she is a particular firm's representative.
- The title converts the source's non-binding 'should' into 'must' ('Firm representatives must disclose...'). This document states at lines 31-35 that its guidance is recommendation only and that 'should' means suggested, not required, so an obligation-phrased title overstates the source even though the rule body is correctly phrased.
- Scope limit to public responses is not expressible in the fixed applies_when vocabulary, but the rule text and check both say 'public response', so the limit is adequately stated.
- Deterministic is defensible: the check is for the presence of an identification of the responder as a firm representative, not for adequacy or prominence.
- Authority 'guidance' matches the source document; the quote is a whole sentence (the embedded '419' is a source line number artifact).
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 the complete heading sentence of Section VI, Recommendation 3. It is not truncated and has no stray list number.
- The rule keeps the source's 'should'. The title also says 'should'. The public-response limit is stated inside the rule text, which is acceptable because the vocabulary has only the basis 'unsolicited-request'.
- The rule is atomic. The separate recommendation that the representative name a contact person or department for follow-up is not bundled in.
- Treating it as deterministic is defensible. The check asks whether the public response identifies the responder as the firm's representative, and presence or absence of that identification settles it.