Orlando Sentinel

FDA urged to let abortion pill be sold at pharmacies in U.S.

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NEW YORK — The socalled abortion pill — dispensed only in clinics, hospitals and doctors’ offices — should be made available by prescripti­on in pharmacies across the country, according to a group of doctors and public health experts urging an end to federal restrictio­ns on the drug.

The appeal to the Food and Drug Administra­tion came in a commentary published Wednesday in the New England Journal of Medicine. Among the 10 co-authors were doctors and academics from Stanford, Princeton and Columbia universiti­es, as well as leaders of major reproducti­ve-health organizati­ons.

The restrictio­ns have been in place since the drug, mifepristo­ne, was approved for use in the U.S. in 2000. They stipulate that the drug, marketed as Mifeprex, may not be sold in pharmacies and that providers of the drug undergo a certificat­ion process.

“The restrictio­ns on mifepristo­ne are a shameful example of overregula­tion run amok,” said one of the authors, Dr. Beverly Winikoff of the New Yorkbased research organizati­on Gynuity Health Projects.

According to the commentary, 19 deaths have been reported to the FDA among the more than 3 million women who’ve used Mifeprex in the U.S. since 2000.

The FDA’s media office referred a reporter to a 2016 document asserting that restrictio­ns on Mifeprex remain necessary for safety reasons. The office declined further comment.

According to the latest federal figures, medical abortions — generally a two-pill regimen using Mifeprex and the drug misoprosto­l — accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.

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