Do not use calls to value that pre-judge patient benefit
Rule
A firm-generated presentation should not include a call to value (a call to action paired with a value proposition, e.g. 'Call FIRM X now — it's the best option for your difficult-to-treat patients!') that pre-judges the benefit of the medical product for individual patients.
Check
Look for calls to action that assert or imply a benefit conclusion for the patient (e.g., 'the best option,' 'start improving your patients' lives'). A violation is a call to value that pre-judges patient benefit, as opposed to a neutral call to action such as directing the HCP to read the article.
Escalate when
Whether a given call-to-action phrase pre-judges benefit versus is a neutral invitation to read further requires judgment.
Where this comes from
Section V, Q5 · page 30. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.
…ons based on elements other than the communication’s substance: celebrity endorsements, emotional appeals unrelated to the scientific content, gifts, promotional tag lines, jingles, and premium offers. For this reason, the enforcement policy outlined in this guidance does not extend to firm-generated presentations of scientific information on unapproved use(s) that use any of the foregoing communication techniques. Additionally, the enforcement policy outlined in this guidance does not extend to firm-generated presentations of scientific information about an unapproved use of the firm’s approved/cleared medical product that include calls to value that pre-judge the benefit(s) of the medical product for individual patients. Examples of calls to value that pre-judge the benefit(s) of the medical product for individual patients include “Call FIRM X now for more information on [Medical product X] — it’s the best option for your difficult-to-treat patients!” and “Click here to start improving your patients’ lives today.” In contrast, inclusion of a call to value that does not pre- Contains Nonbinding Recommendations …
- Document
- FDA guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (final)
- 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
- a36a07e1efd950b7a2a8f6b3…
FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.