Women's Health

FDA Says it Will Allow Cheaper Version of Preterm Birth Drug



The Food and Drug Administration announced Wednesday that the agency won’t stop special pharmacies from making a cheaper version of the recently approved drug called Makena, which many woman depend on to prevent preterm labor.

Earlier this month, KV Pharmaceutical of St. Louis gained government approval to be the exclusive seller of the drug, and the company said it was going to raise the price from $10 to $20 a dose up to $1,500 a dose – putting the cost of injections throughout the course of a pregnancy at $30,000.

The news of the high price outraged many in the medical community, including Dr. Manny Alvarez, senior managing editor of health at FoxNews.com and chairman of the Department of Obstetrics and Gynecology and Reproductive Science at Hackensack University Medical Center in New Jersey,

“There were concerns about the quality of unregulated drugs, and as a result, the FDA has given exclusive manufacturing to St. Louis company KV Pharmaceutical. But for the government to give the exclusive rights of the drug to a single company who now wants to significantly profit from the manufacturing of this drug is quite alarming, inappropriate and immoral,” he said. “This drug is not expensive to manufacturers, as proven by the independent pharmacy services who have been providing this drug for as little as $10 per injection.”

Previously, the drug's maker warned pharmacies to stop making the cheaper version or they could face FDA enforcement. But the FDA said Wednesday that the pharmacies can continue making the cheaper version.

According to the Centers for Disease Control and Prevention, more than a half million babies in the U.S. – that's 1 in every 8—are born premature each year.

The Associated Press contributed to this report.