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Case Detail


Response to DDMAC Untitled Letter to KV Pharmaceutical Co.
(Regulatory Proceeding)
On June 11, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to KV Pharmaceutical Co. on May 17, 2007 regarding KV's allegedly improper promotion of Clindesse in an e-Pharm/alert e-mail. Clindesse is a drug approved by FDA for treating bacterial vaginosis. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because it lacked any empirical basis for asserting that the email misled anyone. WLF also argued that the letter was improper in light of DDMAC's failure to provide any sort of guidance document on Internet and e-mail promotion, something that FDA has promised to provide since at least 1998. WLF also charged that DDMAC violated KV's First Amendment rights in attempting to prohibit KV from making any mention of clinical studies on the effectiveness of Clindesse.
Case Status:
Awaiting FDA response.
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