FDA Ad/Promotion Enforcement Continuing on Same Track: Analysis

Although the CDER Office of Prescription Drug Promotion (OPDP) issued fewer enforcement letters in 2020 than in 2019, two Arnall Golden Gregory attorneys say they see little change in enforcement policy or practices in 2021. Their analysis finds that OPDP “will continue to focus its enforcement energies going after false and misleading promotions, rather than off-label (e.g., unapproved) use promotion.”

However, they write, the agency has made very clear in past statements that it will take action, despite having lost some court cases, and is likely to test the legal waters again if it finds an unlawful promotion with “good facts” of clear violation and public harm risks.

While there are rumors of a forthcoming FDA guidance on social media, the report says the timing, scope, and subject matter are uncertain.

The attorneys say they expect OPDP to continue reviewing more closely the presentation of risk information, such as prominence and placement. “It is clear that OPDP thinks that many promotions are not properly balanced,” they write. “While in some pieces the risk information might have been present, OPDP challenged that the placement was so small when placed in comparison or conspicuousness to the larger positive messaging, or was difficult to find, that the overall promotion was ‘misleading.’”

Looking at FDA’s advertising and promotion enforcement in 2020, the report finds that OPDP issued four Warning Letters and two Untitled Letters, down from the three Warning Letters and seven Untitled Letters issued in 2019. High-risk products such as those containing Boxed Warnings are most likely to receive Warning Letters if there are promotional violations, the attorneys say.

Their review of industry activities says that 2020 was a transformative year for pharmaceutical marketing initiatives, with conferences and drug company booths becoming virtual. “FDA did not issue guidance specific to virtual booths and conferences,” the analysis says. “Until the agency does issue guidance (if it does), existing FDA guidance applies. The same requirements (e.g., fair balance, truthful, and not misleading, providing the prescribing information) still apply, even if the virtual booth is a space-limited platform.”

The attorneys report seeing an increased industry interest in marketing on social media platforms and an increased reliance on e-mail communications. “Remember,” they say, “e-mails (and their subject lines) can be ‘labeling’ and must comply with FDA’s promotional requirements.”