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Case Detail


Response to DDMAC Warning Letter to ISTA Pharmaceuticals
(Regulatory Proceeding)
On November 8, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to ISTA Pharmaceuticals, Inc. on November 2, regarding ISTA's allegedly improper promotion of Vitrase, a drug used as an adjuvant to increase the absorption and dispersion of other injected drugs. DDMAC alleged that a journal advertisement for Vitrase was false and misleading because it omitted important risk information regarding the drug. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because ISTA included all the necessary risk information in the "brief summary" portion of its advertisement. WLF argued that there is no requirement that a drug manufacturer repeat that same risk information in the "creative" portion of its advertisements. WLF also argued that if DDMAC wishes to adopt a new rule stating that it is no longer sufficient to include risk information in the "brief summary," it may do so only after following notice-and-comment rulemaking procedures.
Case Status:
Awaiting FDA response.
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