Prior guideline was to only use pill up to 49 days into pregnancy
The new FDA-approved regime on the abortion pill was welcomed Wednesday by abortion rights groups who say the drug expands options for women but was criticized by opponents who assert serious risks remain.
The FDA changes mean that drug Mifeprex, the brand name for mifepristone, can be used 70 days into pregnancy instead of the prior FDA guideline of only up to 49 days into pregnancy.
The drug is two pills taken over two days, and it blocks a hormone called progesterone that’s needed for a pregnancy to continue, the FDA says.
“After reviewing the supplemental application (from the drug manufacture), the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling,” the FDA said.
The FDA’s updates to the drug label was praised by Planned Parenthood. which said it “represents a significant step forward for science, for women and for health care providers who want to give our patients the highest quality care,” according to Raegan McDonald-Mosley, the organization’s chief medical officer.
“Studies show medication abortion has a 99 percent safety record, and that medication abortion is up to 98 percent effective in ending an early pregnancy,” McDonald-Mosley said.
The American Civil Liberties Union said the FDA decision brings the labeling “in step with years of research.”
The FDA action comes as Arizona Gov. Doug Ducey considers a bill mandating that the drug be prescribed according to the old FDA label, the ACLU said.
“The label update will expand options early in pregnancy, particularly in states where access to medication abortion is under attack,” Jennifer Dalven, the ACLU’s director of Reproductive Freedom Project, said in a statement.
“It also is an opportunity to remind politicians across the country to stop playing politics with medicine. Instead of creating obstacles to high-quality care, politicians should do their job to protect, not endanger the health of women across the nation,” Dalven said.
But Anna Paprocki, staff attorney Americans United for Life, noted how the FDA has restated the drug can be deadly and cannot be given without medical oversight.
“The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women’s health,” Paprocki said in a statement.
“While the abortion industry will falsely celebrate the label change as a green light to its practice of skirting regulations, it would be wise to remember that women and girls have been injured and killed … by the abortion industry’s flagrant disregard for the previous FDA label,” Paprocki added.