KV Pharma and the Drug Price Wars

At the bottom of my last post I looked at the recent case of KV Pharma and its new drug Makena, which was approved last month by the FDA under the Orphan Drug Act for prevention of premature birth.  Makena is a form of progesterone that has been available for decades at a cost of $10-20 per week from compounding pharmacies, but now KV Pharma, which went to the trouble of registering their version of the product has a 7 year monopoly on sales of the product (thanks to the Orphan Drug Act), which they have priced at $1500 per injection.  The drug is dosed weekly from weeks 16 through 20 of gestation.  The penalties associated with trying to provide the compound the old way should give any pharmacist reason to think twice.

Two US Senators (Amy Klobuchar, D-Minn and Sherrod Brown, D-Ohio) have asked the Federal Trade Commission to look into the pricing matter and investigate whether the $1500/injection price tag constitutes anti-competitive behavior.  The senators also charge that KV Pharma's patient assistance program is insufficient.  You can see the press release and letter, which uses words like 'price gouging', here.


As is often the case, Pharmalot is all over this.  This week they asked for an explanation from Jamie Love of Knowledge Ecology International.  Love points out a number of issues stemming from the use of the Orphan Drug Act to secure this approval along with its exclusivity.  The Orphan Drug Act was originally enacted to incentivize manufacturers to make otherwise unprofitable medicines available for diseases that strike relatively few patients.  In the case of Makena, the compound was already available to pregnant women since the 1950's.  So even though KV Pharmaceuticals did perform clinical trials, and the rest of the research was done by the NIH (see here for the full list of trials), and KV does not hold the patent on the progesterone compound (hydroxyprogesterone capoate, apparently no one does according to the Orange Book), they still receive the seven-year market exclusivity under the law.  The Pharmalot Q&A with Love is here, which includes links back to their earlier coverage of the story.  Love's blog noting how the Orphan Drug Act could be improved is here.