Tuesday, July 31, 2012

New Filings in K-V Pharma vs FDA Case ($KV)

KV's Memorandum in Opposition to FDA's Motion to Dismiss. I thought they did a poor job responding to this argument by the FDA: "This exclusivity provision, by its plain language, does not guarantee a drug protection from competition. It applies only to bar FDA from approving certain NDAs, ANDAs, and BLAs. It does not bar FDA from approving another sponsor’s NDA or BLA for the same drug for a different indication, nor does it prevent FDA from approving another sponsor’s NDA or BLA for a different drug for the same indication. This provision makes no mention of compounded drug products."

Brief of Amici Curiae Alere Women's and Children's Health, LLC and Interested Physicians in Support of Defendants: "Plaintiffs come to the Court with unclean hands in another respect as well. Whereas FDA's designation of Makena under the ODA protects Makena from direct competition from another NDA for the same drug for the same indication, Plaintiffs have attempted to leverage that limited protection into a much broader monopoly. Most obviously, Plaintiffs seek to turn their ODA designation into protection from competition from legitimate pharmaceutical compounding. [...] Plaintiffs' own behavior indicates that they will use any declaratory or injunctive relief from this Court in an effort to dissuade physicians and pharmacies from engaging in even permissible compounding. [...] Although Plaintiffs apparently believe an expanded monopoly is necessary in order for Plaintiffs to recover the inflated purchase price they paid for the NDA, that is not the concern of this Court... [...] The decision of many doctors... to prescribe for a given patient a compounded version of 17P that does not contain benzyl alcohol as a preservative is an appropriate exercise of their professional medical judgment that is permitted under the FDCA." This is very well argued.

Something else interesting. I had thought that the "preservative-free 17P" was just a smokescreen so that people could avoid paying for Makena. However, the Alere brief points out that "it is not known whether, and to what extent, use of benzyl alcohol as a preservative in a drug poses a risk to a fetus when administered to a pregnant woman."

I'm still predicting that there's no way KV gets their injunction and so they file for BK this quarter.

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