FDA Promoted Illegal Compounding, KV Tells DC Circ.

Law360, New York (March 12, 2013, 6:18 PM EDT) -- Bankrupt drugmaker KV 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, KV 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....
To view the full article, register now.