The price of a drug used to delay birth in women at high risk of delivering prematurely is going to skyrocket following Food and Drug Administration approval of a prescription form of the product, a synthetic form of the hormone progesterone.

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer the progesterone shots to high-risk women. But because there has not been a commercial product available, women have obtained the drug from so-called compounding pharmacies, which make it to order. The pharmacies have typically charged about $10 to $20 per shot for the drug, which is given weekly.

Last month, however, the FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose. The company said, however, that it would establish a “comprehensive patient assistance program” to ensure that the drug was available to every woman who needs it.

Physicians were incensed at the high price K-V plans to charge. “I’ve never seen anything as outrageous as this,” Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia, told the Associated Press. Other doctors echoed his sentiment. The burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.


About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.

Meanwhile, women are unlikely to be able to continue to get the drug at compounding pharmacies. K-V sent letters to the pharmacies warning them of potential FDA action if they keep distributing the drug.