Which statement best reflects policy on including off-label information in promotional materials?

Which statement best reflects policy on including off-label information in promotional materials?

• A. Promotional materials may include off-label information
• B. Promotional materials require regulatory review
• C. Promotional materials should include only approved labeling and FDA-required information
• D. Promotional materials must be updated annually

Answer: (C)

Information in promotional materials must reflect only what is in the product’s approved labeling and the FDA-required safety information. Off-label information—uses or indications not approved by the FDA—may not be promoted because it can be misleading and constitutes promotion of an unapproved use, which is restricted by law. The strongest standard is to base all promotional content on the labeling the FDA has reviewed and to include mandated warnings, contraindications, and safety statements. Regulatory review is important, but it does not authorize including off-label uses; other timing rules, like updating annually, aren’t the core policy here.

Information in promotional materials must reflect only what is in the product’s approved labeling and the FDA-required safety information. Off-label information—uses or indications not approved by the FDA—may not be promoted because it can be misleading and constitutes promotion of an unapproved use, which is restricted by law. The strongest standard is to base all promotional content on the labeling the FDA has reviewed and to include mandated warnings, contraindications, and safety statements. Regulatory review is important, but it does not authorize including off-label uses; other timing rules, like updating annually, aren’t the core policy here.