DC Circ. Revives K-V's FDA Enforcement Row

Law360, New York (January 9, 2014, 3:55 PM EST) -- The D.C. Circuit on Tuesday revived K-V Pharmaceutical Co.'s suit attempting to force the U.S. Food and Drug Administration to block pharmacies from producing cheaper compounded versions of K-V's preterm-birth prevention drug Makena.

In a brief order, a three-judge panel for the appeals court vacated a September 2012 order by U.S. District Judge Amy Berman Jackson that had dismissed the suit. Judge Jackson’s ruling found that the FDA's enforcement actions are immune from judicial review unless Congress specifically intended in a statute to curb the agency's...
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