FDA eases restrictions on abortion pill
Use of medications to terminate pregnancies could increase.
WASHINGTON — New recommendations for the abortion pill announced Wednesday by the Food and Drug Administration could increase use of the medication to terminate a pregnancy in the country.
The new label changes the recommended dosage of the two drugs used in the abortion process. It allows the treatment to be used up to 70 days into pregnancy— threeweeks longer than the old guidelines. And it relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs rather than a physician.
The reality on the ground will not change for most abortion patients, as doctors for years have been legally diverging from the old FDA protocol based on new research. But a handful of states, including Ohio and Texas, have laws requiring abortion providers to adhere at least in part to the FDA-approved label, leading some providers there to all but abandon the use of the abortion pill.
“The label change for medication abortion will mean that it will once again be a real option for Preterm’s patients and women across the state,” said Chrisse France, executive director of Preterm, an abortion provider in Ohio. “We will no longer be forced to practice medicine mandated by politicians whose ultimate goal is to shut us down.”
Anti-abortion groups noted that the new label carries over the old label’s warnings of some of the dangers associated with the drug, including the possibility of infection or death.
“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,” Anna Paprocki, staff attorney for Americans United for Life, said in a statement.
The label change is effective immediately.
It applies to Mifeprex, which is the brand name for mifepristone, one of the two drugs used in medication abortions. It blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg.
A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy.
The FDA said Danco Laboratories, the manufacturer of Mifeprex, applied for the updated label as part of a “supplemental new drug application” submitted to the agency in late May.
The company proposed that the treatment be used to end a pregnancy through the first 70days of gestation. Under the original labeling, the treatment was to be used through the first 49 days of gestation.