Yesterday 9/6/2012, the U.S. District Court for the District of Columbia dismissed KV Pharmaceutical’s suit against the FDA. KV had asked the Court to force FDA to stop the marketing of compounded versions of 17-hydroxyprogesterone caproate cream and related imported API. FDA countered with the argument that the Courts cannot force the FDA to take action that is within its discretion. The Court sided with FDA.
An earlier post here documented KV’s plight – KV’s Makena wasn’t meeting the revenue required to keep the company in business, it filed bankruptcy and filed this suit in a last ditch attempt to satisfy its investors that everything possible had been done.
What appears to be the major problem is that KV did not correctly price the product and could not survive the firestorm of public criticism.
The discussion on compounding in the Court documents is interesting reading.