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FDA won't stop cheap version of preterm birth drug

ATLANTA (AP) - Pregnant women will still be able to get a drastically cheaper version of a new expensive drug that prevents premature birth, federal health officials said Wednesday.

Since the drug was approved, it's been unclear whether women would have to pay $1,500 per dose for the licensed version or could continue to have it made by specialty pharmacies for $10 to $20.

The price increase caused an outcry, and the Food and Drug Administration on Wednesday took the unusual step of declaring that pharmacies can still make the cheap version of the once-a-week shot on an individual basis, as they have for years. The agency said it wouldn't step in unless there was a problem with the safety of the specially made version.

In response, KV Pharmaceutical Co, which has government approval in February to exclusively sell the drug named Makena (mah-KEE'-nah), said it was committed to making sure all women who need the drug have access to it. The company said it plans an announcement this week regarding concerns about the drug's price.

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