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Case Detail


Response to OCBQ Warning Letter to GenTrac, Inc.
(Regulatory Proceeding)
On November 21, 2005, WLF wrote to OCBQ (FDA "Office of Compliance and Biologics Quality"), calling on OCBQ to withdraw a warning letter sent to GenTrac, Inc on November 1 regarding GenTrac's allegedly improper promotion of Thrombin, a product used to stop bleeding. OCBQ alleged that a video for Thrombin violated federal drug laws because it did not contain sufficient risk information. WLF's letter to OCBQ challenged that assertion, noting that the video explicitly warned of the risk of death if Thrombin is misused. WLF argued that OCBQ's policy on risk disclosure is inconsistent with the policy of other FDA offices, which generally do not require disclosure of "sensitivity reactions" in the main body of a promotional piece. WLF called on OCBQ to cease sending such letters until FDA lays out a clear policy regarding what "fair balance" requires. WLF also called on OCBQ and FDA to cease their use of black box warning labels as a means of controlling product promotion, as was done here.
Case Status:
Awaiting OCBQ and FDA response.
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