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Case Detail


Response to DDMAC Warning Letters to PrimaPharm and GlaxoSmithKline
(Regulatory Proceeding)
On July 6, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw warning letters sent to PrimaPharm, Inc. (on June 29) regarding PrimaPharm's allegedly improper promotion of Hydase and to GlaxoSmith Kline (on June 30) regarding GSK's allegedly improper promotion of Zovirax. DDMAC alleged that a sales aid for Hydase was misleading because it failed to disclose all risk information. DDMAC alleged that material regarding Zovirax on GSK's website was misleading because it overstated Zovirax's efficacy and omitted risk information. WLF's letter to DDMAC alleged that both DDMAC letters were inappropriate because they characterized promotional materials as misleading without a sufficient empirical basis and faulted GSK for citing clinical studies whose accuracy DDMAC has no basis for challenging. WLF charged that DDMAC sent its letters without even alleging that anyone was misled; rather, DDMAC is simply fearful that someone might be misled.
Case Status:
Awaiting FDA Response.
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