FDA okays cheap versions of costly preterm birth drug - KMOV.com

FDA okays cheap versions of costly preterm birth drug

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By Lakisha Jackson By Lakisha Jackson

(CBS/AP) $1,500 a dose. That's the cost of Makena, a prescription drug that won FDA approval last month for the prevention of premature birth. But following an outcry over the drug's exorbitant cost, the FDA now says it won't stop special pharmacies from making cheaper versions of the drug.

How much cheaper? For years, so-called "compounding" pharmacies have been making the drug - a synthetic version of the hormone progestin - for high-risk pregnant women for $10 to $20 a dose.

Last month, the drug's maker, KV Pharmaceuticals, 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.

"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action" against pharmacies that compound the drug, the agency said in a written statement.

The FDA announcement was hailed by women's health advocates.

"This is wonderful news and a victory for preemie families that have suffered significant amounts of trauma more than most people can understand," Mary Beth Hazelgrove, executive director of the group Preemies Today, told the Washington Post.

Children born very prematurely often need months of intensive care. Many suffer disabilities. The cause of sudden preterm delivery is not understood, but it occurs in black mothers at much higher rates than whites or Hispanics.

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