Extract to table

However, the PI identifies several clinically significant risks that must be communicated in promotional materials that make efficacy claims

It requires that when promotional materials reference clinical studies, the materials must not present such data in a misleading manner

1(e)(5), promotional materials for prescription drugs must not omit material facts about the drug, including facts relating to side effects, contraindications, and effectiveness

The FDA's framework for prescription drug advertising distinguishes between two types of advertisements: (1) "reminder advertisements," which present the drug name without making any claims regarding the drug's efficacy, dosage, or safety and are therefore exempt from the requirement to include risk information in brief summary; and (2) "product-claim advertisements," which make affirmative claims regarding the drug's efficacy or safety and must include a fair balance of risk information

Because the ad makes affirmative efficacy claims, it cannot avail itself of the reminder-ad exemption and must include adequate risk information, including all material labeled risks

The banner ad will likely be the primary focus of OPDP's enforcement analysis, and the formal response must address both the unsubstantiated claim and the risk-information omission with specificity and thoroughness