RALEIGH, N.C. (WNCN) — When it comes to the use of pregnancy-ending drugs, the abortion bill passed by the General Assembly has the same cutoff point as the U.S. Food and Drug Administration — 10 weeks.
So under the bill now sitting on Gov. Roy Cooper’s desk, would anything really change?
THE CLAIM: The bill “is right in line with FDA protocol,” Tami Fitzgerald, the executive director of the NC Values Coalition, which opposes abortion.
THE FACTS: “Definitely, there is more to it than that,” said Rebecca Kreitzer, an associate professor of public policy at the University of North Carolina and an abortion policy expert who has written extensively on the topic.
A medication abortion involves taking two prescription drugs, mifepristone and misoprostol, days apart. Prescription medications accounted for 53 percent of all abortions in 2020, up from 39 percent in 2017, according to the Guttmacher Institute.
Page 13 of the bill includes a provision that says an abortion-inducing drug could only be prescribed or given after a doctor verifies the probable gestational age of the fetus is no more than 70 days.
That’s the same period of time for which the FDA approved mifepristone in 2016, after its initial approval in 2000 was for seven weeks.
But what if the FDA changes that recommendation again to expand that window of time?
As the bill is presently written, that would not matter.
Kreitzer says that time frame is outdated, pointing to research that indicates the safety of mifepristone through 12 weeks.
“It’s not unusual for drugs to have somewhat outdated information, because there’s a pretty long process in order to update the official labeling and guidance from the FDA,” Kreitzer said.
She says when mifepristone was first approved, it was placed in what is called the REMS protocol — or, risk evaluation and mitigation strategy — to provide more oversight over its use. Other drugs in REMS include the anti-smoking medication Chantix, along with Klonopin, Oxycontin and other drugs that Kreitzer says are dangerous and addictive.
The American College of Obstetricians and Gynecologists has pushed for that to change, Kreitzer said.
“So it’s actually not really appropriate for mifepristone to be governed under the REMS protocol in general anyway because mifepristone is a safe and effective drug now,” she said.
There’s also a difference between the doses recommended by the FDA and what doctors prescribe in what is known as off-label use.
There is no provision in the bill to prohibit off-label prescriptions inside the 10-week window, and the only mention of the term in the 47 pages of legislation appears in the definition of an abortion-inducing drug.
“Some anti-abortion advocates are saying that going against the official FDA guidance indicates sort of like a recklessness or a danger or risk to public health,” Kreitzer said. “But actually, it’s the contrary. It’s very common and very safe for providers to prescribe off label.”
Another requirement in the bill might more greatly affect access to those pills than the 10-week cutoff point: Additional in-person appointments with doctors.
North Carolina presently requires a woman to meet in person with a doctor one time before she can be prescribed those two drugs.
The bill would require multiple in-person visits to doctors — some interpretations say at least three — including one 72 hours before the woman receives the drugs to meet the informed-consent requirement, and another to actually receive the “first drug or chemical.”
Doctors also must schedule a follow-up exam with the woman 7-14 days after she takes the pills, and “make all reasonable efforts to ensure that the woman returns for the scheduled appointment,” though there is nothing in the bill requiring the woman to actually show up for it.
“One thing that’s important to note about this bill is that it includes a lot of different provisions that require a lot of extra work for providers,” Kreitzer said. “A lot of extra data reporting. A lot of extra in-person appointments. And this does a couple of things. One is, it drives up the cost because it requires more person-hours to do that work, and two, it means that there’s less time available for other people to get appointments that they need.”