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Case Detail


Response to DDMAC Untitled Letter to MGI PHARMA, Inc.
(Regulatory Proceeding)
On February 6, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to MGI PHARMA, Inc. on January 28 regarding MGI's allegedly improper promotion of Gliadel Wafer, a drug approved for treatment of high-grade malignant gliomas after a tumor is removed. DDMAC alleged that a journal advertisement for Gliadel Wafer was false and misleading. WLF's response took particular issue with DDMAC's assertion that the ad included an unsubstantiated claim. The claim in question -- that Gliadel Wafer can begin working earlier than chemotherapy -- is substantiated by well-conducted animal studies. WLF argued that the First Amendment prohibits FDA from barring all mention of animal studies in ads for FDA-approved drugs, particularly where (as here) a disclaimer could eliminate any possibility that doctors reading the ad could be misled.
Case Status:
Awaiting FDA Response.
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