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Case Detail


Response to DDMAC Warning Letter to Bioniche Pharma Group Limited
(Regulatory Proceeding)
On April 21, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Bioniche Pharma Group Limited on April 4 regarding Bioniche's allegedly improper promotion of Sotradecol, a drug approved by FDA for treating some types of varicose veins. DDMAC alleged that a product brochure posted on Bioniche's web site was false and misleading because it omitted important risk information regarding the drug and made inappropriate comparative claims. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because Bioniche included all necessary risk information in the brochure. WLF argued that there is no requirement that a manufacturer repeat that same risk information a second time in the "creative" portion of its brochure. WLF's response took particular issue with DDMAC's criticism of Bioniche's web site, given that DDMAC has failed to issue any guidance documents on internet promotion -- despite repeated promises to do so.
Case Status:
Awaiting FDA Response.
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