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Drug Maker Attempted to Capitalize on the Lives of Infants

Tuesday, April 5th, 2011

There is a synthetic form of progestin called hydroxyprogesterone caproate, or 17P, that is used to prevent mothers-to-be from delivering prematurely. Treating a mother at risk of having a preemie with hydroxyprogesterone caproate was found, in tax-payer funded studies by the National Institute of Child Health and Human Development, to reduce the incidence of pre-term births, which naturally means that babies suffer fewer of the complications that plague preeemies. The studies also found that giving this drug to mothers-to-be at risk of premature delivery could save the health care system at least $2billion per year.

Until recently, the drug had been available only through “compounding pharmacies” (pharmacies that formulate drugs that aren’t commercially available), at a cost of about $10 to $20 per dose. But the FDA recently licensed one manufacturer, KV Pharmaceuticals, to manufacture the drug commercially, and exclusively, for the next seven years.

What usually happens at the point where a manufacturer is given exclusive rights to market a drug is that compounding pharmacies are told that they may no longer produce the drug.

And that would have happened this time – if KV Pharmaceuticals hadn’t done something that has caused a huge uproar in the maternal-fetal medicine and obstetrics community. It raised the price of the drug from the $10 to $20 per dose that compounding pharmacies had been charging to (are you sitting down?) $1,500 per dose.

No, that’s not a typo.

They raised the price by an average of 100 times what it had been.

Remember, it was tax-payer dollars that funded much of the research, so the raise in price could not be attributed simply to recouping research costs. And driving the price that high would put it out of reach of most women (and babies) who needed it. A full course of the drug, given between the 16th and 36th weeks of pregnancy, had previously cost about $400. The price increase would push that cost to $30,000!

This story, at least, has a happy ending. Although, according to this article in the Seattle Times, KV Pharmaceuticals agreed  to drop the price to $690 per dose (still outrageously high, in the opinion of most in the obstetrics community), the FDA decided to allow compounding pharmacies to continue to formulate the drug when presented with a prescription.

But just imagine all the mothers and babies who would have suffered had the FDA allowed KV to put profits ahead of all else, and ordered compounding pharmacies to cease formulating the prescription.

As a maternal-fetal specialist and a mother, it sends shivers up my spine.

– Yvonne S. Thornton, MD, MPH