Matrixx disputes Hamburg comments
This article was originally published in The Tan Sheet
Executive Summary
FDA unfairly asked Matrixx Initiatives to recall its intranasal Zicam products with zinc, the firm argues. In response to Commissioner Margaret Hamburg's Feb. 8 comment that the agency's Zicam actions led to "a good outcome," Matrixx CEO William Hemelt says, "FDA made a major mistake that deprived the public of an effective and safe treatment for colds" (1"The Tan Sheet" Feb. 15, 2010, In Brief). Hemelt says in a Feb. 24 2letter the agency's reliance on previously rejected evidence linking zinc to anosmia and failure to engage with Matrixx "did a serious disservice to the truth, and also to due process." Hemelt added FDA's refusal to share documentation supporting its actions is inconsistent "with your attempts to restore confidence in the integrity of the agency.