Mamas on Bedrest: Makena Company Now Suing the FDA!

July 9th, 2012

In what appears to me to be a desperate move to save itself from bankruptcy, on July 6, 2012 the K-V Pharmaceutical company announced it has filed suite against the US Food and Drug Administration (FDA), claiming that the FDA is not cracking down on compounded versions of injectable 17 hydroxyprogesterone, the compound that K-V markets as Makena, used to prevent preterm labor.

As you may recall, in February 2011, K-V Pharmaceuticals received approval from the FDA to “exclusively” produce and market 17 hydroxyprogesterone capoate as Makena. Once K-V received this approval from the FDA, they immediately jacked up the price of the injections from roughly $10-20 per injection to $1500 per injection. Consumers and physicians were outraged! Advocacy groups such as the March of Dimes severed relations with the company. And in a clear move of dissatisfaction, the FDA declined to act against compounding companies and pharmacies that continued providing the compounded formulations at the markedly cheaper rates. K-V tried to save face by cutting the costs of the injections by more than half to $690, but that did little to ease the already bitter pill many felt they had been fed by K-V, and most people continued to prescribe and take the compounded formulations.

The lawsuite comes at a time when it is patently obvious to everyone that if K-V doesn’t do something soon, it is going to need to file bankruptcy. What is interesting is the fact that the day before  the lawsuit was filed, the FDA issued a statement saying that they recommend that physicians and consumers use Makena instead of compounded formulations to ensure safety, purety and efficacy. Still, in what seems to be a pattern, K-V Pharmaceuticals forged ahead with their own agenda, filing their lawsuit.

It is unclear what K-V Pharmaceuticals hopes to gain from the FDA by filing this lawsuit. Makena is FDA approved to prevent preterm labor in women at risk. K-V pharmaceuticals holds the rights. The FDA has even come out and supported K-V, by recommending that the compounded formulation is a better option. Yet, K-V continues to bite the hand that is trying to feed it, using much needed funds that may have been put to better use trying to better market Makena to create consumer appeal and loyalty.

But it’s hard to say that K-V Pharmaceuticals’ mission was to ever create consumer appeal or loyalty. The company has been in trouble for quite some time, most notably since they were barred from manufacturing their own products due to problems with their manufacturing practices. Moreover, they won no friends when they marketed Makena at the price gouging cost of $1500/injection. I guess one may say that it’s now a “Fait Accompli”. K-V Pharmaceuticals has alienated probably the last known ally that they may have had.


Choose Makena

K-V Pharmaceutical Company v. FDA, U.S. District Court, District of Columbia, No. 12-01105.

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