Response to Warning Letters to 3M Pharmaceuticals and Alcon Research Ltd.
- Case Date: 11/15/2006
- Project Name: Health Care Project
On November 15, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw warning letters sent to 3M Pharmaceuticals (on October 19) regarding 3M's allegedly improper promotion of Maxair Autohaler) and to Alcon Research Ltd. (on October 20) regarding Alcon's allegedly improper promotion of Nevanac. DDMAC alleged that a "flashcard" for Maxair and a sales aid for Nevanac were misleading because they failed to disclose all risk information and made unsubstantiated superiority claims. WLF's letter to DDMAC alleged that both of DDMAC's letters were inappropriate, because they characterized promotional materials as misleading without a sufficient empirical basis and inappropriately devalued animal studies relied on by the manufacturers. WLF charged that although DDMAC claimed that some readers might interpret the materials as making claims that the manufacturer has not substantiated, DDMAC provided no evidence that any consumers actually interpreted the materials in that manner.
|Awaiting FDA Response.|
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