Have medical/scientific personnel independent of sales and marketing generate the response

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

Rule

Responses to unsolicited off-label requests should be generated by medical or scientific personnel who are independent from the firm's sales or marketing departments.

Check

Confirm the author/originating department of the response is medical or scientific affairs, not sales or marketing.

Escalate when

Authorship or departmental origin of the response cannot be confirmed.

Where this comes from

Section V, Recommendation 5 · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…sponse to an unsolicited request should be scientific in nature. When responding to an unsolicited request for information, a firm should respond with material that is scientific in tone and presentation. The material should not be promotional in tone or presentation. Furthermore, the responsive material should not be distributed along with other material or information that is promotional in nature or tone. 5. Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments. FDA recommends that questions or requests about off-label uses be referred to the firm’s medical or scientific representative or department. FDA recommends that medical or scientific personnel have specialized backgrounds in responding to unsolicited requests for information, including important training, such as appropriately narrowing questions, tailoring responses only to the specific quest…

Open the original at page 11 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 verbatim by Section V, Recommendation 5, lines 286-287: responses to unsolicited requests should be generated by medical or scientific personnel independent from sales or marketing departments.
- The rule keeps 'should' and adds no breadth beyond the source's own framing.
- One requirement - who authors the response. It is distinct from the separate sales/marketing no-input recommendation at lines 296-298, so keeping them as two rules is right rather than a bundling problem.
- Judgment is acceptable: 'independent from sales or marketing' requires confirming departmental origin and independence rather than matching a literal string, and the escalate-when handles unconfirmable authorship.
- 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 V Recommendation 5 verbatim, is a complete sentence, and the rule restates it faithfully with 'should'.
- The rule covers only who generates the response. The separate recommendation that sales and marketing have no input is handled by US-SCI-005, so this rule is atomic.
- Judging personnel independence and where a response originated is a judgment call. Severity, locator and applies_when are appropriate.

Nearby rules

US-SCI-005