17P; Makena;

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: Price of Makena Cut in Half!!!

April 3rd, 2011

The Price of Makena Cut in Half!

K-V Pharmaceuticals, following unprecedented pressure from Medical organizations, consumers, politicians and the March of Dimes has cut the cost of Makena in Half! Yet despite this dramatic price cut, critics still say that K-V Pharmaceuticals has not gone far enough. The company, which has posted losses in the hundreds of millions for 2009 and 2010, was relying heavily on the sale of Makena to be able to remain solvent.

The March of Dimes Severs Ties With K-V

The March of Dimes stated in a press release that although the price cut is a step in the right direction, it is nevertheless severing all professional ties to the drug maker. It is asking KV Pharmaceutical to stop displaying the March of Dimes name and logo on marketing materials that identify the company and its Ther-Rx subsidiary as a donor.

Medical Societies and Politicians Turn Up the Heat

When K-V Pharmaceuticals initially set its price at $1500/injection (and 15-20 are required for a full course of treatment!) Medical societies and politicians alike balked.  The cost of this treatment would be prohibitive for Medicaid programs, already facing budget cuts, and many women in great need of the treatment would not be able to receive it. Sen. Sherrod Brown (D-OH) and Sen. Amy Klobuchar (D-MN) called on the Federal Trade Commission to determine whether KV Pharmaceutical was violating antitrust laws.

The American Congress of Obstetricians and Gynecologists (ACOG) called the price reduction “a woefully inadequate response” and said $690 is still “prohibitively high.” The Society for Maternal Fetal Medicine (SMFM) issued a similar statement. Earlier this year ACOG, SMFM, and the American Academy of Pediatrics petitioned the drug maker to make Makena more affordable.

“We would like to have a price that’s comparable to what is charged for the compounded version,” said Dr. Saade, SMFM’s president, in an interview with Medscape Medical News. “It could be a little higher to reflect the value of FDA approval and oversight.” A reasonable price, he said, would be $50.

The Government’s Response

Perhaps the most devastating blow for K-V Pharmaceuticals came from the FDA. Because Makena is actually 17p and gained approval under “orphan drug status”, there were already plenty of pharmacies nationwide who were compounding the drug at the $10-$20/injection price. K-V Pharmaceuticals tried to halt production by compounding pharmacies stating that they now held the sole legal rights to production. However, the FDA did not support their claims and under their rules, they have chosen not to  enforce action against pharmacies that compound hydroxyprogesterone caproate.”

The Long and the Short of It

To say that this is unprecedented is an understatement! For a company to receive such swift and harsh backlash that has effectively halted their business is phenomenal. But for once it seems like the people are getting a break. 17P has been shown to be effective in the prevention of preterm labor. For a pharmaceutical company to take what has been widely known and affordably prescribed for years and essentially hold it hostage was unspeakable-Until now. For once the voice of the people chimed louder than that of big business! With opposition from consumers, medical groups, Advocacy groups, politicians and the government, the gouging that once seemed inevitable by K-V Pharmaceuticals has been effectively halted and once again, 17P is available to those mamas who really need it.

Score one for the people!

This summary is prepared from April 1, 2011 MedScape News Alert.