The Food and Drug Administration on Wednesday disputed a drug company’s claim that pharmacies can no longer produce less expensive versions of a drug long used to reduce the risk that women will give birth prematurely.
The statement was aimed at defusing a controversy that erupted after the agency approved the drug Makena to prevent preterm births. Makena’s owner, KV Pharmaceutical of St. Louis, is charging $1,500 a dose for the drug. The same compound had been available for years for about $10 to $20 a dose.
The statement came a day after The Washington Post reported the intense criticism that has arisen over Makena. After word of Makena’s price began to spread, Internet sites for pregnant women became filled with angry commentary. Some created Facebook pages lambasting KV. The price also drew harsh criticism from several members of Congress, as well as many doctors and medical groups, including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics.
But in a statement Wednesday, the FDA said it would not exercise its authority to prevent pharmacies from producing less expensive “compounded” versions of the drug unless evidence emerged that patient safety was at risk.
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