The U.S. Food and Drug Administration on Wednesday changed the label on the "abortion pill," supporting a lower dose, fewer doctor visits, and extending its use further into a pregnancy.
The move undercuts laws in Texas, Ohio and North Dakota that require physicians to only prescribe Mifeprex, better known as "RU486", solely in line with FDA label recommendations. Around 90% of the 1.1 million U.S. abortions yearly come in the first trimester of pregnancy, and the pills now account for about one-third of these early abortions.
The FDA's older label dated to the 2000 U.S. approval of the drug. It recommended three doses of the drug, 600 milligrams in all, and limited their use to the first 50 days of a pregnancy. The manufacturer, Danco, asked for the updated label in response to medical studies supported by the American College of Obstetricians & Gynecologists since 2013, which showed a single 200 milligram dose of the drug and its use up to 70 days after the end of the last menstrual period "is equally is safe and effective," according to the agency.
"This brings the label into line with best medical practice," said Beverly Winikoff of Gynuity Health Projects in New York at a teleconference for reporters held by abortion rights supporters. "Requiring women to take three pills instead of one is bad medicine."
Laws requiring clinics to follow the old label, which required repeated clinic visits, led to drops in medical abortions in those states. Medical abortions in Texas went from 15% of abortions in 2011 there to less than 2% after the passage of an FDA label adherence law, for example.
Abortion opponents such as Michael Gonidakis of Ohio Right To Life, who supported the law restricting use of RU486 to the FDA labels, had previously told BuzzFeed News that FDA labels were the "gold standard" for medical treatment.
"In the end, it is obvious that the FDA's new protocol serves only the interests of the abortion industry," said National Right to Life's Randall O'Bannon in a statement sent to BuzzFeed News, by making abortions more available to more more women. O'Bannon claimed the pill is unsafe under any protocol.
Thirty-eight states still have other laws restricting the use of the abortion pill, according to the Guttmacher Institute. They typically require extra doctor visits or require in-person prescription of the drug, precluding "telemedicine" opportunities in rural states.
Janet Krepps of the Center for Reproductive Rights noted at the briefing that the revised label for Mifeprex allows health care providers beside doctors to prescribe the pills, which abortion providers hope will lead to more use of the the drug, which some women prefer as a more private alternative to a surgical procedure. "This is an important step in the fight against laws that put politics above the health of women," she said.
Dan Vergano is a science reporter for BuzzFeed News and is based in Washington, DC.
Contact Dan Vergano at email@example.com.
Got a confidential tip? Submit it here.