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 leveraging the “consistent with labeling” (CFL) final guidance, an industry attorney said.
How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads
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.
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Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
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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.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.