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Barr To Resume Revised Seasonale DTC Ads By End Of January

This article was originally published in The Pink Sheet Daily

Executive Summary

Changes are being made to the voice-over in the television commercial for the extended-regimen oral contraceptive following a December FDA ad division letter. Barr will continue Seasonale DTC ads until the launch of Seasonique.

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Barr's Seasonale DTC Ads Return With Strengthened Risk Information

Ads include information on the risk of bleeding compared to monthly cycle pills during the first year of treatment; a 2004 FDA "untitled" letter said earlier Seasonale ads minimized that risk. The company says the modified ads will run through the end of June.

Barr's Seasonale DTC Ads Return With Strengthened Risk Information

Ads include information on the risk of bleeding compared to monthly cycle pills during the first year of treatment; a 2004 FDA "untitled" letter said earlier Seasonale ads minimized that risk. The company says the modified ads will run through the end of June.

FDA Cites Barr Seasonale TV Ad For Misleading Risk Information

The direct-to-consumer ad fails to reveal that patients may experience breakthrough bleeding or spotting for up to a year, an FDA ad division letter states. The agency also says the risk information contained in the ad is obscured by the "compelling visuals."

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