FDA cites compounder for making tainted version of KV's Makena

After the FDA approved KV Pharmaceutical's ($KV.A) Makena in 2011, the drugmaker asked the agency to stop compounding pharmacies from making their much cheaper versions of the drug. The drugmaker claimed there was no guarantee of the sterility of compounded versions of the drug for women with a history of giving birth prematurely. KV filed for bankruptcy reorganization after the agency turned its back on the request, but the FDA may now be coming around.

The FDA last month cited a compounder for the very problem KV warned of, making a version of Makena under unsanitary conditions. As Regulatory Focus points out, the warning letter against Village Fertility Pharmacy in Waltham, MA, says laboratory analysis found foreign and particulate matter in vials of its compounded hydroxyprogesterone caproate, the generic name for Makena, as well as in other drugs. The letter was posted Thursday on the FDA's website.

The FDA took a big interest in the sanitation conditions at compounding pharmacies in 2012 after one was tied to a fatal meningitis outbreak. The outbreak exposed a patchwork of state regulations covering compounding pharmacies, which originally made up drugs on an individual basis. Some compounders have expanded nationwide and function more like drug manufacturers than pharmacies. The FDA stepped in with inspections after Congress lashed it for not having a better handle on the new generation of compounders. Congress last year passed a law giving the FDA more defined authority over compounders.

KV meanwhile jumped on the compounding pharmacy controversy to convince doctors (who could be held liable) that it is better to be safe than sorry when treating patients for whom Makena is appropriate. KV also worked with state programs on discounts for its drug, which had a retail price of $595 compared to the $10 to $20 a dose for compounded version. The efforts worked and KV lifted itself out of bankruptcy.

As it turns out, KV is also getting a second shot with its lawsuit to force the FDA to stop compounded, competing versions of Makena. In January, the U.S. Court of Appeals in Washington, DC, ordered a lower court to reconsider its September 2012 decision in favor of the FDA, in part because of the new law giving the agency more authority to regulate compounding pharmacies. KV will have a new warning letter illustrating its point to add to the file.

- here's the warning letter
- more from Regulatory Focus