FDA To Permit Pharmacies To Make Cheaper Version of Pre-Term Labor Drug
I’ve been saying this for years: Why on earth do we keep handing all the profits from government-funded drugs back to the pharmaceutical companies? Why don’t we simply contract with different companies to provide them, and rotate them every five years or so? If this particular drug controversy didn’t have such a clear narrative, odds are, nothing would have happened to give affordable access back to pregnant women: 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. On Wednesday, the FDA challenged KV’s warning to specialty pharmacies that had been producing the cheaper versions of the drug that the agency would no longer permit that. “This is not correct,” FDA spokeswoman Beth Martino said in an e-mailed statement that was later posted on the agency’s Web site. Although the agency usually does not recommend patients use compounded versions of FDA-approved drugs, “in order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound” the agent, the statement said.
FDA To Permit Pharmacies To Make Cheaper Version of Pre-Term Labor Drug
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on April 1, 2011. Filed under