Maker of pregnancy drug reduces price amid outcry

WASHINGTON — The drug company lambasted for increasing the price of a pregnancy drug from $20 to $1,500 a dose said Friday it's cutting the revised price by more than half.

KV Pharmaceutical of St. Louis said in addition to reducing the price of Makena, a drug that prevents women from giving birth too soon, it would expand financial assistance for women who could not afford the drug. It also said it was expanding rebates for Medicaid programs and believes its new pricing structure "will deliver net cost savings to Medicaid programs and private insurance plans in one year."

The reduction to $690 a dose came two days after the Food and Drug Administration (FDA) publicly invited competition for the drug by announcing it would continue to allow so-called compounding pharmacies to make and sell a version of the drug.

The drug, a synthetic form of progesterone commonly called 17P, is recommended for women at high risk of delivering prematurely. The drug is administered via injection weekly for about 20 weeks.

KV Pharmaceutical's price reduction puts the list cost of a full course of treatment at $13,800, effective immediately. That's down from $30,000 under KV's old price, but still a sharp jump from the $400 a woman could expect to spend if she had the drug made at a compounding pharmacy.

More than 500,000 women worldwide give birth prematurely each year, and many of the babies don't survive. Those who do are at increased risk for many health problems, including mental disability, cerebral palsy and autism.

KV's price reduction did not tamp down the controversy.

Hours after KV's announcement, the March of Dimes, which had accepted about $1 million in donations since 2006 from a KV subsidiary and allowed it to use the charity's logo on its website, said it was severing its relationship with the drugmaker.

Others said the new price was still too high.

"While the new price may represent a significant reduction, it remains excessively inflated," said George Saade, president of the Society for Maternal-Fetal Medicine.

Until this year, an FDA-approved version of 17P was not available.

So the only alternative was to take a prescription for the drug to a compounding pharmacy that produced individual batches of the drug for between $10 and $20 a dose.

In February, the FDA granted KV Pharmaceutical exclusive rights to make Makena for seven years.

KV subsequently priced Makena at $1,500 a dose and sent letters to compounding pharmacies warning of a potential FDA crackdown if they did not stop making their versions of the drug.

The company's actions triggered a furor and put the FDA in an awkward position because it has no direct authority over drug prices.

The agency reacted by announcing Wednesday that contrary to KV's assertion, it wasn't planning on blocking compounding pharmacies from making the drug, essentially encouraging patients to go that route to obtain it.

In statements, KV defended its pricing as justified by research-and-development costs.

But in its announcement, the FDA noted KV relied on a study by the federally funded National Institutes of Health to demonstrate the drug's effectiveness.

There was no immediate comment by the FDA on KV's announcement.

Material from The Associated Press and The Washington Post is included in this report.