| The letter said: "FDA has, however, declined to provide any details of its analysis; it has not told (in fact declined to tell) Matrixx what data it used, what analysis or analyses it used, and whether any of the issues and points Matrixx raised in its draft response had been considered, much less accepted or rejected. Matrixx is, therefore, unable to engage in any meaningful discussion of FDA’s conclusions or the basis for them. To do so, Matrixx would need an opportunity to review the data relied upon, the methodology used, the statistical measures employed, and other details. As FDA is well aware, the outcome of any review of data is only as good as the data that go into it and the design of the study that produces it. Matrixx is mystified as to why FDA will not share its analysis. One would expect that FDA would, consistent with general scientific principles, be willing to share its analysis and discuss its methodology and assumptions, if only to assure itself that no mistake has been made. In addition, fundamental fairness dictates that, when a federal agency unilaterally destroys the market for a product, at the very least it owes the affected company a clear explication of its rationale and the basis for it, and a meaningful opportunity to comment on both the rationale and the basis for it. FDA has also never explained why it took the actions that it did on June 16 without any discussion with Matrixx. FDA had known since at least 2005 that the Zicam products were the subject of multiple anosmia complaints. In fact, Matrixx believes that FDA not only knew about the complaints, but evaluated them in 2004 -2005 in a series of health hazard evaluations, which it has also refused to share. FDA took no action then. It is hard to imagine that a situation known to FDA since 2005 became so urgent in 2009 that FDA was forced to take action without first giving Matrixx the opportunity to help the agency understand the totality of the facts and available scientific evidence. In sum, Matrixx knows no more today, November 16, about why FDA did what it did on June 16 than it did then, and has had no meaningful opportunity to discuss FDA’s rationale and basis for it, much less to disagree with or rebut FDA’s conclusions. And Matrixx knows no more today than it did on October 14 about why FDA decided to adhere to its June 16 actions, and has had no opportunity to discuss FDA’s rationale and basis for it, much less to disagree with or rebut FDA’s conclusions." :theflyonthewall.com |
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