K-V Can't Challenge FDA Enforcement Decisions, Judge Rules

Law360, New York (September 6, 2012, 8:27 PM EDT) -- A Washington federal judge on Thursday dismissed K-V Pharmaceutical Co.'s attempt 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, saying the agency's enforcement actions are not subject to judicial review.

U.S. District Judge Amy Berman Jackson dismissed K-V's suit, saying the FDA's enforcement actions are presumed to be immune from judicial review unless Congress had specifically intended in a statute to curb the agency's enforcement discretion. But the legislative branch has not...
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