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Case Detail


Response to DDMAC Untitled Letter to Eli Lilly and Co.
(Regulatory Proceeding)
On October 16, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Eli Lilly and Co. on September 21, 2007 regarding Lilly's allegedly improper promotion of Cymbolta in a professional mailer. Cymbalta is a drug approved by FDA for treatment of a variety of conditions, including depression, anxiety disorder, and pain management. WLF's response took particular issue with DDMAC's assertion that the materials included an unsubstantiated claim. The claim in question -- that those treated with Cymbalta experience significantly less pain interference with overall functioning -- was based on several thorough studies conducted by Lilly. FDA was critical of the methodology of the studies. WLF responded that the First Amendment does not permit FDA to ban all discussion of the studies; at most, FDA can require Lilly to include additional disclaimers that point out potential shortcomings in the studies.
Case Status:
Awaiting FDA response.
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