On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V Pharmaceutical Company (“K-V”) and its subsidiary, Ther-Rx Corporation (“Ther-Rx”).[1] K-V and Ther-Rx had sued claiming federal regulators unlawfully allowed pharmacies to compound[2] a cheaper alternative to the synthetic progesterone drug Makena. The United States District Court for the District of Columbia dismissed the suit in 2012 but was directed to reconsider its ruling last week in light of a 2013 D.C. Circuit decision addressing the reviewability of agency enforcement discretion, like the FDA’s.
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