Friday, June 15, 2012

KV Pharma Related ($KV): Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)

An FDA press release just came out about the Makena compounding issue:

As explained in a November 8, 2011 statement, in October 2011, FDA received information from Makena’s sponsor, K-V Pharmaceuticals, regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products. The Agency explained that FDA had carefully reviewed the data K-V submitted and would conduct an on-site review of the laboratory analyses. The Agency also stated that FDA had begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.

FDA has completed its review, and the Agency is now providing a brief summary of the results. [...]

Although the analysis of this limited sample of compounded hydroxyprogesterone caproate products and APIs did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products. [...]

FDA emphasizes that it is applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone caproate. The compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.
So, it does not sound like the compounding pharmacies will be prohibited from selling their compounded version that competes with Makena.


Allan Folz said...

I guess with Makena's kind of mark-up KV has the money to grease a few palms.

CP said...

Where are you getting that? It sounds like the compounding situation will remain the same.

Allan Folz said...

My bad. I misread the first time. I tripped up thinking they were saying compounding hydroxy...caproate would exceed the scope of pharmacy compounding hence was being dis-allowed. I think they are saying that, but moreso, it's not dangerous enough that they are going to make it at all an enforcement priority.

CP said...


They aren't even supposed to regulate compounding at all and it pisses pharmacists off. The law was actually changed at one point to remove FDA jurisdiction, but part of the law was found unconstitutional and there was no severability provision for the change to compounding.

Without very pro-Makena actions by the FDA, KV is going to be sunk. The FDA knows that. So the natural bureaucratic way to avoid responsibility is to put out a vague, mealy mouthed press release. Which is what they did.

Did you see my post before with the NYT article, which mentions that the White House specifically intervened to screw KV and keep the price of the drug cheap? Is that going to change?