Mamas on Bedrest: The Latest in the Makena Debacle

November 7th, 2012

An update in the latest in the K-V Pharmaceuticals/Makena saga. Currently, K-V Pharmaceuticals has filed a lawsuit with the US International Trade Commission asking that they impose cease and desist orders on a number of compounding pharmaceutical companies who are distributing 17 HydroxyProgesterone (17P) injections for the prevention of preterm labor and preterm birth. K-V Pharmaceuticals won US FDA approval to distribute and market the injections as Makena in February 2011. Since that time, the company has been embroiled in a public relations nightmare after increasing the price from $10-$20 per injection to $1500 per injection. Now the company is pretty much the pariah of the pharmaceutical industry and obstetrical world and is in bankruptcy as well.

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.

FDA to Review Data on Compounded Versions of Makena

FDA to Review Data on Compounded Versions of Makena

From MedScape Ob/GYN and Women’s Health

November 9, 2011 — The US Food and Drug Administration (FDA) will evaluate manufacturer data on the potency and purity of compounded hydroxyprogesterone caproate (Makena, K-V Pharmaceuticals), according to a statement they released today.

On February 3, 2011, the FDA approved Makena as a specialty injectable for women with a singleton pregnancy before 37 weeks’ gestation who have had at least 1 spontaneous preterm birth. This agent is now available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and represents an alternative to the compounded agent.

In March 2011, the manufacturer of Makena, K-V Pharmaceuticals, sent letters to pharmacists indicating that the FDA will no longer exercise enforcement discretion with regard to compounded versions of hydroxyprogesterone caproate, and in their letter implied that continuing to compound the drug may result in FDA enforcement action.

At that time, however, the FDA called the warning erroneous and said that “in order to support access to this important drug, at this time and under this unique situation, it does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate.”

More recently, in October 2011, K-V Pharmaceuticals submitted data to the FDA regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products.

The FDA notes that according to the analysis of this information provided by K-V, there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested.

“Although FDA has not validated or otherwise confirmed the analyses provided by K-V, FDA has carefully reviewed the data and will conduct an on-site review of the laboratory analyses,” they note.

“In the meantime, we remind physicians and patients that before approving the Makena new drug application, FDA reviewed manufacturing information, such as the source of the API used by its manufacturer, proposed manufacturing processes, and the firm’s adherence to current good manufacturing practice,” they state. “Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.”

Since the drug’s approval, the manufacturer of hydroxyprogesterone caproate has been under scrutiny from various groups for pricing the injection too high relative to the cost of the compounded product available from a pharmacy — at one time the price was about $1500 per Makena injection vs $10 to $20 per injection for a compounded version.