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title pic FDA Drug Approval Leads to Outrageous Increase in the Cost of Preventing Preemies

Posted by Fiona Cole on March 24, 2011

FDA Drug Approval Leads to Outrageous Increase in the Cost of Preventing Preemies

When a woman has a high risk of delivering her baby prematurely, the American Congress of Obstetricians and Gynecologists recommends weekly progesterone shots in order to delay birth and help her reach full term. This protocol has been in effect since 2003 and, up until now, these shots have cost around $10 to $20 for each injection. But a recent FDA approval of the drug has led to a drastic price increase. Preventing premature labor will now cost moms-to-be $1,500 per dose, which could mean a total cost of up to $30,000.

Previously, the progesterone shots were available from “compounding pharmacies.” This means that the shots were made to order and, because no commercial product was available, the price remained low.

KV Pharmaceutical, a drug company based in St. Louis, has since manufactured a synthetic version of the hormone progesterone and presented it to the FDA for approval as a prescription drug for preventing preemies called Makena. Last month, the FDA approved Makena as the first and only commercial form of the premature labor drug.

Some say that this approval will lead to higher medication quality; but the leap in price from around $15 to $1,500 per dose is staggering, especially for any moms-to-be who might already be struggling with worries about a premature delivery. Every year in the U.S., around 500,000 babies are born prematurely. There is concern that this exorbitant price may deter lower-income women or those with poor or no health insurance from receiving treatment and, in turn, increase the number of premature births.

It’s not just moms-to-be who are shocked by KV’s new price. Many doctors are reacting to the news with disbelief. Dr. Arnold Cohen, a Philadelphia-based obstetrician who works out of the Albert Einstein Medical Center, commented to the Associated Press, “I’ve never seen anything as outrageous as this.”

Insurance companies might pick up the tab but, inevitably, insurance rates will rise. Already overstretched Medicaid programs will also feel the burden.

Amid concern over the soaring cost of preventing preemies, KV Pharmaceutical has attempted to project a caring image, stating that it would set up a “comprehensive patient assistance program” to make sure that Makena is accessible to every pregnant woman who might need it.

This may not be much consolation for pregnant women who are stuck with no alternative. While KV offers payment plans to go with their astronomical price tag, they are making sure that their profits are protected. The FDA approval is for exclusive selling rights and the KV has written to the compounding pharmacies warning them of possible FDA action if they continue to distribute the medication.

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