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Case Detail


Response to DDMAC Untitled Letter to Takeda
(Regulatory Proceeding)
On March 19, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Takeda Pharmaceuticals North America, Inc. on March 5, 2007 regarding Takeda's allegedly improper promotion of Rozerem in a direct-to-consumer television advertisement. Rozerem is a drug approved by FDA for treating insomnia. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because it lacked any empirical basis for asserting that readers of the ad would understand the ad to mean that Rozerem had been approved by FDA for use by children. The ten-second ad depicted a mother with school-age children and stated that it was "back to school season." WLF notted that the "reminder ad" said nothing about any of Rozerem's intended uses, and stated that it could easily be understood as suggesting that parents consider taking the drug. WLF noted that FDA had done no consumer testing regarding how viewers interpreted the ad.
Case Status:
Awaiting FDA response.
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