FDA Attempts to Patch K-V Pharmaceuticals Progesterone Mess

FDA Allows Cheaper Version of Preterm Labor Drug To Stay on the Market – Health Blog – WSJ.

A short time ago, there was an uproar because the FDA had given approval to KV pharmaceuticals to be the sole producer of 17-alpha-hydroxyprogesterone caproate, (Formerly named Gestiva)  a drug used to sustain pregnancies in women who produced insufficient amounts of progesterone.

Pharmacies had been preparing these doses and supplying them at about 10 or 20 bucks apiece.

KV had sent a letter to the pharmacies announcing that compounding the doses would no longer be allowed, and that their drug, Makena, at $1500 dollars per dose would be the only drug available. It is extremely important to know that  K-V has no research and development costs to recoup with the introduction of their commercial form of a drug which had been studied and used for years. In fact, fast approval of Makena was based upon a 2003 study funded by the NIH.

This drug is injected weekly to sustain a pregnancy, so you can imagine the cost to the affected mothers. Suddenly the cost of preventing premature babies in the US would be jacked up to multiple billions of dollars.

Of course Obamacare would have the death panels to halt that source of excessive cost.  K-V would need to recoup its investment very quickly.

The new drug by KV pharmaceuticals was named Makena.  The sound of this name set off bells in the mind of yours truly, wondering who paid off Obama to get this windfall of profit due to exclusivity granted by the government for K-V Pharmaceutical Co.   You betcha…. Makena is a Hawaiian boy’s name (but can be given to girls).  The meaning is ABUNDANCE, as in windfall profits for K-V. There HAS to be a political connection larger than the individual political contributions from K-V employees. ……. and it will be unearthed.  Watch closely because some articles are already being scrubbed from the internet.  Two dead ends so far.

Fortunately, this obvious and unconscionable scam and, granting of monopoly status, (similar to the quinine sulfate scam) met with immediate protest.

The FDA now says that the letter from K-V pharmaceuticals was in error, and that pharmacies will not be forbidden to compound doses of 17-alpha-hydroxyprogesterone for individual patients.

More delectable goodies follow:

Adeza is the company which first submitted Gestiva to the FDA for approval in 2006, based on a study paid for by the NIH.  It obtained orphan drug status in Jan, 2007

Adeza merged with Cyctec, and Cyctec merged with Hologic.  And here’s a whole Makena timeline! The blogger estimates that K-V would recoup its entire investment in purchasing the rights of the drug in two short months, at the initially planned, astronomical price.

Hologic  Inc. sold the total rights to its product, Gestiva, 17-alpha-hydroxyprogesterone caproate to K-V Pharmaceuticals in 2008.

K-V Pharmaceuticals was perhaps needing a boost from the government (granting it a monopoly)  because it’s subsidiary, Ethex had been required to recall  incorrectly made pain killers containing excess amounts of active ingredient. More K-V disasters resulted from selling unapproved drugs,  and from dismissal of a vp of corporate strategy and operations.  This company was on the verge of bankruptcy.

K-V’s windfall profits  could be   targeted by lawsuits concerning still births attributed to 17-hydroxy-progesterone, as well as increased incidence of pre-eclampsia and gestational diabetes.

March of Dimes bears responsibility for helping to initiate this debacle, and has been burned by the result.  Here’s the result of their  collusion with MOD DONOR K-V Pharmaceuticals.