At the same time that KV Pharmaceutical was preparing long-threatened bankruptcy papers, the besieged drugmaker also filed a pair of lawsuits against two state Medicaid programs for failing to cover their controversial Makena treatment for premature births. The lawsuits, which were filed against Georgia and South Carolina, followed a lawsuit filed last month against the FDA for failing to prevent some compounding pharmacies from offering lower-cost versions of Makena. KV Pharma “has been unable to realize the full value of its most important product, Makena because of a lack of enforcement of the orphan drug marketing exclusivity granted to K-V for Makena by the FDA,” KV ceo Greg Divis says in a statement. “The lack of enforcement has also led certain state Medicaid agencies to impose barriers to access to Makena on low-income pregnant women at high risk for recurrent preterm birth, despite those states’ legal obligation to cover FDA-approved drugs.”
