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Case Detail


Response to DDMAC Warning Letter to Daiichi Sankyo
(Regulatory Proceeding)
On January 29, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Daiichi Sankyo, Inc.(DSI) on January 12, 2007 regarding DSI's distribution of a promotional wall calendar for Evoxac, a drug used to treat symptoms of dry mouth in certain patients. DDMAC stated that the risks of taking the drug were inadequately displayed -- they were on the back of the calendar. WLF responded that DDMAC's "double disclosure" requirement (requiring that risk information be included both in the detailed "brief summary" portion of the promotional material and in the main body of the ad) is consistent neither with the First Amendment nor with federal statutes. WLF argued that it should be sufficient to reference in the main body of an ad a location to which readers can readily turn to find detailed risk information. WLF argued that requiring too much risk information on an advertisement tends to distract readers from the most important safety considerations for that drug.
Case Status:
Awaiting FDA response.
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