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Case Detail


Response to OCBQ Warning Letter to VaxGen
(Regulatory Proceeding)
On April 6, 2006, WLF wrote to FDA's OCBQ, calling on it to withdraw a warning letter sent to VaxGen, Inc. on March 24, 2006 regarding VaxGen's allegedly improper promotion of its anthrax vaccine rPA102. WLF's letter to OCBQ charged that OCBQ lacks any basis for its allegation that VaxGen's activities were promotional or that VaxGen said anything that the government itself has not already said. WLF argued that the context of VaxGen's distribution of a "Question and Answer" document regarding rPA102 makes clear that VaxGen was not trying to sell anyone the vaccine (which is still in the investigational stage and thus is not on the market), and therefore its truthful statements are fully protected by the First Amendment. WLF took particular issue with OCBQ's letter because the statements to which OCBQ objected (calling them "false or misleading") were virtually identical to statements HHS made in a 2004 press release while hailing the promise of the rPA102 vaccine.
Case Status:
Awaiting FDA response.
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