Exclude sales and marketing personnel from input on off-label response content

Where this comes from

Section V, Recommendation 5 · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…rm’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 questions being asked, providing unbiased responses, and properly documenting responses. By contrast, because sales and marketing personnel are focused by training and experience on promoting a firm’s products, FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information. 6. Information distributed in response to an unsolicited request should be accompanied by the following: \ A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet) \ A prominent statement notifying the recipient that FDA has not approved…

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.