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Case Detail


Response to DDMAC Warning Letter to Hoffman-LaRoche Inc.
(Regulatory Proceeding)
On July 19, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled warning letter sent to Hoffman LaRoche, Inc. (HLR) on July 15, 2005 regarding HLR's allegedly improper promotion of Fuzeon -- based on oral statements made by an HLR sales representative at a scientific conference. Fuzeon is a drug used for treatment of HIV-1 infection. DDMAC alleged that the sales representative's oral statements had the effect of broadening Fuzeon's indications, thereby causing its product insert to lack adequate directions for the use recommended by the oral statements. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because DDMAC lacks legal authority over oral statements, nor has it issued any guidance on the issue. WLF also faulted DDMAC for failing to make any effort to demonstrate that what the sales representative said was less than 100% accurate. WLF argued that the First Amendment protects dissemination of truthful information.
Case Status:
Awaiting response.
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