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Case Detail


Response to Warning Letter to BioMarin Pharmaceuticals
(Regulatory Proceeding)
On October 19, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to BioMarin Pharmaceuticals, Inc. on October 11 regarding BioMarin's allegedly improper promotion of Orapred. DDMAC alleged that a website for Orapred was misleading because it failed to disclose all risk information. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate, in large part because the website did, in fact, include all FDA-required risk information. DDMAC's only complaint was that BioMarin failed to include risk information on every page of the website. WLF's response also noted that DDMAC has never issued any specific guidance document on internet promotions of prescription drugs, despite many promises to do so and despite a 2001 WLF Citizen Petition pointing out the absence of such guidance. WLF argued that DDMAC should refrain from issuing any more warning letters regarding websites until after it provides appropriate guidance.
Case Status:
Awaiting FDA Response.
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