FDA moves to undercut huge price increase by pregnancy drug maker

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FDA moves to undercut huge price increase by pregnancy drug maker

Plain Dealer – The Food and Drug Administration took the unusual step Wednesday of inviting pharmacies to make a legal end run around a St. Louis company that obtained agency approval for a pregnancy drug and promptly raised the price from $20 per dose to $1,500.

The drug, a synthetic form of progesterone trade named Makena, is recommended for women at high risk of delivering prematurely. And the price increase K-V Pharmaceutical Co. ignited a firestorm of objections from patients, medical organizations and political leaders including Sen. Sherrod Brown of Ohio.

Now, the FDA has declared it will not take enforcement action against pharmacies that fill prescriptions for the drug by compounding their own versions instead of using the version marketed by K-V.

The problem arises out of an unusual situation. Until early this year, women obtained the drug from so-called compounding pharmacies that produced it on a made-to-order basis.

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