FDA Promoted Illegal Compounding, KV Tells DC Circ.

Law360, New York (March 12, 2013, 6:18 PM EDT) -- Bankrupt drugmaker K-V Pharmaceutical Co. asked the D.C. Circuit on Monday to allow court review of a U.S. Food and Drug Administration statement soliciting compounded versions of prenatal medicine Makena, saying the agency’s active encouragement of competing products doesn’t merit deference.

In its opening brief, K-V says the FDA should be forced to disavow a March 2011 announcement that it wouldn’t discipline compounding pharmacies for producing versions of Makena, a move that a district judge last year said was not subject to second-guessing by courts....
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