The Food and Drug Administration on Wednesday took the unusual step of announcing that it would allow pharmacies to continue to produce less expensive versions of a drug long used to reduce the risk that women will give birth prematurely.
The move 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 FDA’s 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.
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