FDA urged to let abortion pill be sold at pharmacies
The appeal to the Food and Drug Administration came in a commentary published 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 all providers of the drug undergo a special 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 York-based research organization Gynuity Health Projects.
"Women and their health providers shouldn't have to jump through hoops to get a medication that's been safely and effectively used in this country for a decade and a half."
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, a mortality rate lower than for pregnancy-related deaths among women.
Asked about the commentary, the FDA's media office referred a reporter to a 2016 document asserting that the restrictions on Mifeprex remain necessary for safety reasons.
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.
The new commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office and would no longer have to be on a list of certified abortion providers.
Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, the authors said. ■