Compounding Hydroxyprogesterone: Controversies and Questions

Was the recent FDA ruling on preterm labor drug Makena a victory for compounding pharmacy?

In the past week, pharmacy news has been focused on KV Pharmaceuticals and the price of its new drug Makena (hydroxyprogesterone caproate). After the FDA approval on February 3, 2011, KV Pharmaceuticals released its pricing scheme for the preterm labor drug. The original cost per dose was $1500. As a once-a-week injectable, a full course would have come in at a cost of around $30,000 per patient.

Compounding pharmacies have been compounding hydroxyprogesterone for years with the much lower price of $20 per dose or $400 for a full course of therapy. Not surprisingly, there was a large outcry over the leap in price. To compound the issue further (no pun intended), KV Pharmaceuticals sent out official letters to pharmacies suggesting that they would need to stop compounding the drug or feel the heat of the FDA on their necks.

Here is the most interesting part—the FDA issued a statement saying they did not intend to take “enforcement action” against those who compounded the drug pursuant to a valid prescription and under suitable and safe conditions. This seems to be a bit of a departure from the FDA’s previous stance on compounded products. Generally, they do not allow pharmacies to compound products for which there is a manufactured alternative. Following the public outrage over the price, KV Pharmaceuticals did recently decrease the price of the drug to $690 per dose.

The compounding community has been quick to claim this as a victory for compounding pharmacies and pharmacists, but in terms of patient care maybe this is a victory for both patients and pharmacy overall. Do you think it is a victory for compounding pharmacy? For pharmacy in general? Why?

The bigger question might be why did KV Pharmaceuticals pursue this drug? Why did they launch the drug at the price they did? What was the strategy behind the price cut?

Love to hear your opinions.

(For information on this topic, read "FDA: Pharmacists Can Continue to mix Preterm Labor Drug" in the News & Trends section of the April issue of Pharmacy Times)