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Case Detail


Response to DDMAC Warning Letter to Duramed Pharmaceuticals, Inc.
(Regulatory Proceeding)
On January 20, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Duramed Pharmaceuticals, Inc. on January 4 regarding Duramed's allegedly improper promotion of Cenestin. Cenestin is a synthetic estrogen approved for treating certain symptoms associated with menopause. DDMAC alleged that a professional journal advertisement for Cenestin failed to include sufficient risk information. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because Duramed included all necessary risk information in the "brief summary" portion of the advertisement. WLF argued that there is no requirement that a manufacturer repeat that same risk information in the "creative" portion of the advertisement. WLF's response took particular issue with DDMAC's demand that Duramed disseminate "corrective" promotional messages; WLF noted that FDA lacks statutory authority to require "corrective" messages, and that in any event such a demand violates the First Amendment.
Case Status:
Awaiting FDA Response.
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