Response to DDMAC Warning Letter to DUSA Pharmaceuticals.
- Case Date: 5/1/2007
- Project Name: Health Care Project
On May 1, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a Warning Letter sent to DUSA Pharmaceuticals, Inc. on April 20, 2007 regarding DUSA's advertisement for Levulan Kerastick, a drug approved for treatment of actinic keratosis ("AK," a type of precancerous lesion). DDMAC stated that the advertisement claimed that Levulan was superior to previously available products and was effective in treating all forms of AK. WLF responded that DDMAC lacked any empirical basis for asserting that readers would think that DUSA was claiming that Levulan had been approved for treating the most severe forms of AK. WLF also charged that DDMAC violates the First Amendment and administrative law when, as here, it seeks to prohibit a manufacturer from saying anything about the results of a study on patient preferences -- particularly in light of FDA's failure to release any guidance document setting forth standards for consumer preference surveys.
|Awaiting FDA response|
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