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Case Detail


Response to DDMAC Warning Letter to SuperGen Inc.
(Regulatory Proceeding)
On August 25, 2005, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to SuperGen Inc. on August 18, 2005 regarding SuperGen's allegedly improper promotion of Nipent -- based on SuperGen's mechanism of action booth panel and handout. Nipent is a drug used to treat certain types of leukemia. DDMAC alleged that the promotional material failed to present any risk information and included an unsubstantiated claim about Nipent. WLF's letter to DDMAC alleged that DDMAC's actions were unwarranted because SuperGen included all pertinent information in the package insert that accompanied its promotional material, and because DDMAC had not alleged that any of the information conveyed by SuperGen was false or misleading. WLF also faulted DDMAC for requesting that SuperGen disseminate "corrective" promotional messages; WLF noted that FDA lacks statutory authority to require "corrective" messages, and that in any event such a demand violates the First Amendment.
Case Status:
Awaiting FDA response.
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