K-V Challenge To FDA's Enforcement Order On Thin Ice: Judge

Law360, Washington (August 7, 2012, 10:30 PM EDT) -- A Washington federal judge indicated Tuesday that forcing the U.S. Food and Drug Administration to block pharmacies from producing cheaper compounded versions of K-V Pharmaceutical Co.'s preterm birth prevention drug Makena is an unlikely action, as the agency's enforcement discretion cannot be judicially reviewed.

While K-V claims that the FDA isn't following its traditional enforcement procedures and that it encouraged pharmacies to produce cheaper, compounded versions of Makena's active ingredient — 17-hydroxyprogesterone caproate, or 17-HPC — via a March 2011 press release, U.S. District Judge Amy...
To view the full article, register now.