Do not bundle the off-label response with promotional material

Where this comes from

Section V, Recommendation 4 · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…lict of interest or biases for all authors, contributors, or editors associated with the journal or organization. 4. Information distributed in response 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 reques…

Document

FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)

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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file

Retrieved

2026-09-21 from www.fda.gov

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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.