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K-V Pharma bankrupt – Claims FDA Doesn’t Back Makena

K-V Pharmaceuticals filed for Chapter 11 bankruptcy. After years of GMP issues narrowed the product offering to just one product, Makena (17-hydoxyprogesterone caproate), poor sales of the product couldn’t sustain the company.

In this blog I have discussed the filing and approval of Makena, a product for pre-term labor.  Prior to this approval, the product had been available from compounding pharmacists. Immediately after approval, patient advocates and the media generated a firestorm of protests over the price: $1500 per injection.

K-V has asserted that compounded products were inferior to its NDA approved product.  Yet, an analysis by FDA suggested that this assertion was false although the FDA did find that some compounded products did not meet the impurity specifications set for the Makena NDA, but decided that they did not present a safety concern.

On July 6, K-V filed suit against FDA, requesting the court to force FDA to remove compounded drugs from the marketplace.  In the filing, K-V signaled that it could not stay in business without the financial success of Makena: “Unless FDA publicly signals that it will stop the unlawful competition by non-customized compounded drugs (and thereby give KV’s creditors a reason to believe that KV is likely to be able to meet its financial obligations if given more time), KV will not be able to attract new capital at a reasonable cost, and is likely to exhaust its working capital within three to six months and be forced to file for bankruptcy before then.”

In the suit, K-V is asking the court to (and I greatly summarize):

  1. Declare unlawful, suspend and withdraw FDA’s 2 statements (3/20/2011 & 6/15/2012) regarding its policy of non-enforcement of compounding
  2. Require FDA to take enforcement action against compounders
  3. Not permit use of API that is not covered by K-V’s NDA
  4. Withdraw CMC’s 3/30/2011 statement regarding payments for Makena and compounded products

The K-V bankrupcy filing suggests that even if FDA and CMS were to amend their previous statements, the market for Makena isn’t strong enough to maintain K-V.