FDA Updates Label For Abortion Drug, Making Access Easier In Some States
The FDA has updated the labeling for the abortion-inducing drug Mifeprex, allowing it to be taken at a lower dose and with fewer visits to the doctor's office.
The change brings the drug's label into alignment with common medical practice in 47 states — and will make the drug more accessible to women in three states, where lawmakers had required doctors to prescribe the drug according to the original label.
Mifeprex is the brand name for mifepristone, also known as RU-486. (It's not related to the emergency contraceptive known as the morning-after pill, or Plan B.)
It's used to medically induce abortions, in a two-step process. First, women take mifepristone; two days later, they take misoprostol. The original FDA label instructed providers to administer both doses in the office and have a follow-up visit in the office as well.
As NPR has previously reported, since the abortion drug was approved in 2000, doctors determined it was effective at lower doses and could be used later into a pregnancy — up to 70 days after a woman's latest period, instead of 49 days. They also found that three office visits weren't necessary. Here's Jennifer Ludden reporting last year:
"Lisa Perriera, a Cleveland obstetrician, says researchers found that women can actually take just a third of the dosage and at up through nine weeks' gestation. They also deemed it safe for women to take the second drug on their own, without making another trip to a doctor.
" 'We made it better by making it less costly, by making it easier to use for women,' says Perriera. 'We know it's just as effective, probably actually safer with fewer side effects.' "
The lower dose, fewer trips and later deadline have been standard practice for administering the drugs for years now, according to Elizabeth Nash, a policy analyst at the Guttmacher Institute.
But three states — Ohio, Texas and North Dakota — had passed laws saying doctors must follow the FDA label, which was written based on early trials of the drug and didn't reflect the changes in medical practice over the past 15 years.
That means in those three states, the FDA's new label will make the abortion-inducing drug easier to get.
The National Right to Life Committee issued a statement saying the new protocol "serves only the interests of the abortion industry" by reducing the time and resources required to administer the drug to women.
"The updated label is more aligned with evidence-based medicine and has the potential to expand abortion access for Ohio women," Chrisse France, executive director of the Preterm clinic in Ohio, said in a statement. "We are pleased to announce that as of today we will be offering medication abortion to more women, with fewer required visits."
But Nash notes that while the new label means women across the country can now access the drug at the same dose and time frame, that might change, again.
Arizona's Legislature passed a bill earlier this month that would hold doctors in the state to the restrictions from the 2000 label — no matter what the current FDA guidelines are. It's sitting on the governor's desk.
Copyright 2020 NPR. To see more, visit https://www.npr.org.