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Case Detail


Response to DDMAC Untitled Letter to Biogen Idec Inc.
(Regulatory Proceeding)
On February 10, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Biogen Idec on December 15, 2005 regarding Biogen Idec's allegedly improper promotion of Zevalin in connection with a brochure sent to pharmacists regarding reimbursement issues. Zevalin is a biological product approved for treatment of some forms of non-Hodgkin's lymphoma. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because a brochure designed to facilitate reimbursement of purchase costs should not be subject to the same "risk disclosure" standards as product labeling. WLF's response took particular issue with DDMAC's conclusion that the brochure was deficient even though it referenced the accompanying "package insert," a document that provided detailed explanations of the risks of using Zevalin. WLF also criticized DDMAC's two-month delay before releasing the Zevalin letter to the public.
Case Status:
Awaiting FDA response.
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