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Case Detail


Response to DDMAC Untitled Letter to Intermune
(Regulatory Proceeding)
On April 6, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Intermune, Inc. on March 28, 2006 regarding Intermune's allegedly improper promotion of Infergen in a journal advertisement. Infergen is a drug approved by FDA for treating chronic HCV infection. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because FDA does not challenge the legitimacy of the reported study and has stated in other contexts that manufacturers are prohibited from including the type of additional information that DDMAC now says should have been included. WLF noted that the additional information in question has never been approved for inclusion on Infergen's labeling. WLF charged that FDA apparently prohibits inclusion of such information if it would make patients more likely to take the drug, but requires inclusion of information that would make patients less likely to take the drug.
Case Status:
Awaiting FDA response.
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