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Case Detail


Response to OCBQ Untitled Letter to Wyeth
(Regulatory Proceeding)
On June 12, 2006, WLF wrote to OCBQ (FDA's Office of Compliance and Biologics Quality), urging it to withdraw an untitled letter sent to Wyeth Pharmaceuticals, Inc. on April 13, 2006 regarding Wyeth's allegedly improper promotion of ReFacto (a biological product approved by FDA to control bleeding and for use during surgery for patients suffering from hemophilia). WLF's letter to OCBQ argued that safety claims contained in a Wyeth consumer-directed brochure were consistent with ReFacto's FDA-approved labeling, that OCBQ had no basis for rejecting the studies upon which Wyeth based its safety claims, and that OCBQ had failed to provide any empirical basis for concluding that anyone was misled by Wyeth's brochure.
Case Status:
Awaiting FDA Response.
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