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Case Detail


Response to DDMAC Warning Letter to Cephalon
(Regulatory Proceeding)
On March 19, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Cephalon, Inc. on February 27, 2007 regarding Cephalon's allegedly improper promotion of Provigil. DDMAC alleged that a presentation for Provigil (handed out to Maryland health officials) was false and misleading because it failed to disclose all risk information and discussed off-label uses of the drug. WLF responded that to the extent that Cephalon could be deemed to have been supplying information regarding off-label uses of Provigil, the speech was constitutionally protected noncommercial speech; WLF noted that Cephalon was not attempting to sell any product to the Maryland officials and thus there can be little justification for FDA regulation of manufacturer speech in that context, in the absence of evidence from FDA that the speech was untruthful. WLF also called on DDMAC to develop a coherent policy regarding speech to State healthcare officials.
Case Status:
Awaiting FDA response.
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