KV gets a second shot at forcing the FDA to restrict compounders on Makena

KV Pharmaceutical ($KV.A) has been through more than most companies can imagine, including a trip to bankruptcy court and back to stay in the game with its one product, premature birth drug Makena. But in a positive turn of events for the St. Louis-area company, it is getting a second shot at forcing the FDA to restrict cheaper compounded versions of the drug.

The U.S. Court of Appeals in Washington, DC, this week told a lower court it needs to reconsider its September 2012 decision in favor of the FDA in light of a more recent court ruling against the FDA's authority, Bloomberg reports. According to FDA Law Blog, the court of appeals cited a court case the FDA lost last year saying it could no longer allow the importation of a foreign-made version of a drug that states were using in executions. It also cited the new Drug Quality and Security Act, which was passed in November in response to last year's fatal fungal meningitis outbreak that was traced back to drugs made by a compounding pharmacy.

There has been a lot of water under the bridge since the FDA in 2011 approved Makena, a hormone given to pregnant women with a history of giving birth prematurely. The agency at the time refused to ban compounded versions of the drug, which were going for $10 to $20 a dose compared to the $595 price KV finally landed on. The company sued the FDA, claiming that the quality of compounded versions could not be guaranteed, and said if the agency didn't ban them, it would have to file for bankruptcy. The FDA didn't and KV did.

KV battled on, working with state programs on discounts for its drug. It reorganized itself out of bankruptcy then started to see more interest in Makena when patients began dying in the outbreak of fungal meningitis and the FDA began ordering many compounders to recall their sterile drugs. Compounded versions of the premature birth drug were among the products that some compounders had to recall.

Bloomberg said the FDA did not comment about the court reversal, and the company did not respond to FiercePharma's request for comment today.

- read the Bloomberg story
- get more from the FDA Law Blog