According to the PhRMA code, promotional materials provided to healthcare professionals by, or on behalf of a company should: Which statement is NOT a requirement?

According to the PhRMA code, promotional materials provided to healthcare professionals by, or on behalf of a company should: Which statement is NOT a requirement?

• A. Be accurate and not misleading
• B. Provide equal coverage to both on-label and off-label indications
• C. Reflect the balance between risk and benefit
• D. Be consistent with all other FDA requirements governing communication between MSLs and HCPs

Answer: (B)

The key idea here is that promotional materials to healthcare professionals must be truthful, non-misleading, and balanced, and they must align with FDA labeling and related rules. PhRMA guidelines require that information reflect the product’s approved uses (on-label), present a fair balance of risks and benefits, and be consistent with FDA requirements for communications between medical science liaisons and HCPs. It does not mandate promoting or giving equal weight to off-label indications; in fact, promoting off-label uses is not allowed. So the statement about providing equal coverage to both on-label and off-label indications is not a requirement and would run counter to the code’s intent.

The key idea here is that promotional materials to healthcare professionals must be truthful, non-misleading, and balanced, and they must align with FDA labeling and related rules. PhRMA guidelines require that information reflect the product’s approved uses (on-label), present a fair balance of risks and benefits, and be consistent with FDA requirements for communications between medical science liaisons and HCPs. It does not mandate promoting or giving equal weight to off-label indications; in fact, promoting off-label uses is not allowed. So the statement about providing equal coverage to both on-label and off-label indications is not a requirement and would run counter to the code’s intent.