Response to OCBQ Untitled Letter to Wyeth
- Case Date: 6/12/2006
- Project Name: Health Care Project
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.
|Awaiting FDA Response.|
More Information and Downloads:
4/13/2006: Download OCBQ's Warning letter to Wyeth
Press Release: WLF Calls on OCBQ to Withdraw Untitled Letter on ReFacto