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Case Detail


Response to DDMAC Untitled Letter to Eli Lilly
(Regulatory Proceeding)
On August 4, 2006, WLF wrote to DDMAC (FDA's Division of Drug Marketing, Advertising, and Communications),calling on DDMAC to withdraw an untitled letter sent to Eli Lilly and Co. on July 27 regarding Lilly's allegedly improper promotion of Alimta. DDMAC alleged that a patient brochure for Alimta was false and misleading because it did not include sufficient information regarding product risks and approved uses. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because Lilly included detailed risk information in the prescribing information that accompanied the brochure; WLF said that there is no requirement that a manufacturer include risk information twice in its promotional material. WLF's response also took issue with DDMAC's conclusion that the brochure might mislead patients regarding Alimta's approved uses, given that the brochure made no claims regarding uses not approved by FDA and DDMAC collected no survey data indicating that any patients were misled.
Case Status:
Awaiting FDA Response.
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