Which statement is not true about promotional materials?

Which statement is not true about promotional materials?

• A. Promotional materials must present an unbiased picture of the drug, including its risks and benefits
• B. All MSLs should offer the same promotional materials provided by the company and not "make their own"
• C. Promotional materials can include off-label drug information
• D. Promotional materials must adhere to FDA requirements and label information only

Answer: (C)

Promotional materials must present information that is truthful, balanced, and aligned with the FDA-approved labeling, including clear discussion of risks and benefits. They are not permitted to promote uses or provide information about indications beyond what the labeling approves. Off-label information in promotional content could mislead clinicians and patients and run afoul of regulatory rules designed to prevent promotion of unapproved indications. In contrast, discussions of off-label information are generally reserved for regulated, non-promotional scientific exchanges under strict guidelines. That’s why the statement that promotional materials can include off-label drug information is not true. The other options reflect compliance expectations: using company-approved materials to maintain consistency, and ensuring content adheres to FDA requirements and the approved labeling.

Promotional materials must present information that is truthful, balanced, and aligned with the FDA-approved labeling, including clear discussion of risks and benefits. They are not permitted to promote uses or provide information about indications beyond what the labeling approves. Off-label information in promotional content could mislead clinicians and patients and run afoul of regulatory rules designed to prevent promotion of unapproved indications. In contrast, discussions of off-label information are generally reserved for regulated, non-promotional scientific exchanges under strict guidelines. That’s why the statement that promotional materials can include off-label drug information is not true. The other options reflect compliance expectations: using company-approved materials to maintain consistency, and ensuring content adheres to FDA requirements and the approved labeling.