Blogs: The Reinvented Pharmacist

Compounding Hydroxyprogesterone: Controversies and Questions

Published Online: Thursday, April 7, 2011
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)
Fred Eckel, RPh, MS, Editor-in-Chief of Pharmacy Times
Blog Info
This blog focuses on what our Editor-in-Chief sees as the future of pharmacy.
Author Bio
Fred Eckel, RPh, MS, is the Editor-in-Chief of Pharmacy Times, a position he has held since 2002. Mr. Eckel is a professor at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He serves as executive director of the North Carolina Association of Pharmacists.

In this blog, Eckel will provide commentary on relevant issues impacting pharmacists and pharmacy professionals, including the merging of pharmacy benefit managers, the implications of health care reform, the conversion of major drugs from prescription to over-the-counter, trends in pharmacy careers, and opioid abuse. He will also discuss legislative issues that impact pharmacists, and comment on the evolving role of the pharmacist.
Blog Archive
Latest Issues