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How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

Guardrail
FDA policies, research and enforcement provide guardrails for CFL promotion to consumers. (Shutterstock)
Key Takeaways
  • Absent any CFL guidance specific to consumer promotions, companies should review longstanding FDA policies, and research and enforcement priorities, Sidley Austin’s Torrey Cope said.
  • Experience with dietary supplement health claims showed the word “may” and other qualifying language can reflect data limitations.
  • An Opus Regulatory consultant said sponsors can leverage real-world evidence under the CFL guidance to promote to subpopulations who were under-represented in clinical studies.

Sponsors should review longstanding US Food and Drug Administration concepts on consumer-friendly language and claims limitations, and Office of Prescription Drug Promotion research priorities and enforcement, when developing direct-to-consumer promotions...

Speaking at the Drug Information Association’s recent advertising and promotion conference, Torrey Cope, a partner at Sidley Austin in Washington, DC, offered guardrails for sponsors developing consumer-directed promotions under the...

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