Case Detail

Response to OCBQ Warning Letter to MedImmune Vaccines, Inc.
(Regulatory Proceeding)
On June 30, 2005, WLF wrote to OCBQ (FDA's "Office of Compliance and Quality"), calling on OCBQ to withdraw a warning letter sent to MedImmune Vaccines, Inc. on June 21, 2005 regarding MedImmune's allegedly improper promotion of FluMist, an influenza vaccine. OCBQ alleged that one of the MedImmune's direct-to-consumer promotional labeling pieces for FluMist violated federal drug laws because it did not contain sufficient risk disclosure information. WLF's letter to OCBQ alleged that OCBQ lacks any basis for its claim that the risk disclosures contained in MedImmune's flyer were misleading. WLF charged that OCBQ lacks any statutory or constitutional basis for its allegation in the absence of any evidence that some consumers have been misled by the promotional piece.
Case Status:
Awaiting response.
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