UPDATED: Loss of Makena suit against FDA compounds KV's problems

KV Pharmaceutical ($KV.A), the drugmaker that filed for Chapter 11 bankruptcy protection last month, has taken another blow. A federal judge has thrown out its lawsuit trying to force the FDA to stop compounders from offering much cheaper but unapproved versions of Makena, a hormone to reduce the chances of premature birth.  

The judge said KV was asking the court to "oversee the FDA's enforcement activities," and it couldn't do that, Bloomberg reports. The St. Louis-area company filed the suit in July after the FDA refused to block compounded versions of the hormone, which go for $10 to $20 a dose, compared with Makena, which hit the market at $1,500 a dose, but which KV has negotiated down to less than $300 for some state Medicaid programs.

The drugmaker had already embarked on another course, filing suits against individual states to try to get them to readily pay for Makena. Some, like Illinois, where KV recently filed suit, have preapproval requirements for the pricier Makena, and not for compounders' versions, which KV argues are inherently less safe. KV spokesman Tony Herrling in a statement to FiercePharma pointed out to Bloomberg that KV had already gotten a court to require Georgia to cover the drug. It also has a suit pending in Washington, DC.

"The recent court decision in Georgia  requiring that State's Medicaid agency to honor its legal obligation to cover FDA-approved drugs and reimburse for Makena, together with progress we are making in other jurisdictions and continued growth in prescriptions for Makena, demonstrates that our multi-tiered strategy is advancing our key objective -- to ensure that all clinically-indicated patients have access to Makena," Herrling said.

Still, if KV had won the case, it would have been able to do with one suit what it now must try to do one state at a time, not an easy row to hoe for a company that is in bankruptcy. In the suit, the drugmaker pointed out that Makena is essentially its only product now and told the court that the outcome of the litigation against the FDA would weigh heavily on its future.

KV has been reduced to relying on the one licensed product because it had to shut down production of other products after it ran afoul of the FDA in 2008 for hiding safety issues from the agency. Its former CEO landed in jail, the company had to pay a big fine and shareholders sued it when its stock tanked.

- read the Bloomberg story

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