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The Spokesman-Review Newspaper
Spokane, Washington  Est. May 19, 1883

FDA undercuts drug price jump

 WASHINGTON – 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. The price increase by K-V Pharmaceutical Co. ignited a firestorm of objections.

 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.

 Until early this year, women obtained the drug from so-called compounding pharmacies that produced it on a made-to-order basis. Although custom-made for each patient, it had been priced at only about $20 per dose.

 Then last February, K-V was granted exclusive rights for seven years to make Makena, ending, at least in theory, the need for made-to-order versions.

 But the company’s pricing announcement, coupled with letters K-V sent to pharmacies warning them of possible FDA action if they kept compounding the drug, aroused a strong push-back from several members of Congress.

Tribune Washington bureau