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Case Detail


Response to DDMAC Warning Letter to Endo Pharmaceuticals
(Regulatory Proceeding)
On June 30, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Endo Pharmaceuticals, Inc. on June 28, 2005 regarding Endo's allegedly improper promotion of Lidoderm. Lidoderm is a topical anesthetic patch used for pain relief. DDMAC alleged that Endo violated federal drug laws by disseminating direct mail pieces regarding Lidoderm. WLF's letter to DDMAC alleged that DDMAC's actions violated the First Amendment, made questionable allegations regarding "minimizing" of risk information, and made inappropriate use of Endo's "regulatory history." WLF's response took particular issue with DDMAC's demand that Endo cease disseminating clinical data regarding Lidoderm that was published in a reputable, peer-reviewed medical journal. WLF alleged that DDMAC's efforts to suppress this data violate the First Amendment.
Case Status:
Awaiting response.
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