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Case Detail


Response to DDMAC Warning Letter to Dutch Ophthalmic USA
(Regulatory Proceeding)
On June 30, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Dutch Ophthalmic USA (DO) on June 28, 2005 regarding DO's allegedly improper promotion of VisionBlue on DO's web site. VisionBlue is a tissue staining agent for use as a medical aid in ophthalmic surgery. DDMAC alleged that the web site lacked risk information about VisionBlue. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate in that FDA has never issued any guidance on internet promotion of prescription drugs, despite its promises to do so. WLF took particular issue with DDMAC's demand that DO 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 response.
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