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Medication abortions with Mifeprex are a growing segment of early abortion procedures in the United States, accounting for 23 percent of all nonhospital abortions, though abortion rates overall continue to fall.
But until this week, the FDA's protocol for using the drug was based on outdated information that reflected cautionary labeling practices and the earliest years of research and development. Now, it's been updated to meet the standard many abortion providers were already using, relying on evidence-based medicine to ensure that patients seeking abortion get the best possible care.
None of this would be newsworthy — the FDA updates drug labels all the time — except for the fact that this is a medication used in abortions, so of course the anti-choice community is beside itself.
Especially in Ohio, Texas, and North Dakota, which had been using the disparity between the drug's label and generally accepted use practices to make it harder for patients to access abortions. The FDA just delivered them a big slap in the face, and unfortunately, they're probably not going to take it lying down.
First, the skinny. Mifeprex, the brand name for mifepristone, is used in combination with a prostaglandin drug called misoprostol to terminate early pregnancies. Patients take one drug, wait for a set period of time, and then take the other. Medication abortion is highly effective, and extremely safe — like all abortion procedures, it carries fewer risks than giving birth. A 2014 study covering nearly 55,000 abortions found that 0.31 percent of medication abortions resulted in "major complications," which includes a variety of medical issues, requiring hospital admissions. By contrast, 600 pregnancy-related deaths occur annually, according to the CDC.
Way back when the drug was approved in 2000, patients were required to come to a doctor's office to take 600mg of the drug, followed by 800mcg of misoprostol on the third day, also in a medical clinic. Then, they had to come back two weeks later for an examination to confirm that the pregnancy had been terminated, as incomplete abortion carries health risks (not least of which is that people who don't want to be pregnant would probably be quite upset if their abortions weren't successful).
They also had to get a medication abortion within 49 days of their last period — if patients were any further along in pregnancy, they needed surgical abortions.
Evidence-based medicine saves the day
Over the years, standards of care have changed, as care providers have drawn upon experience, medical research, and medication guidance developed in other nations. They found that a lower dose of mifepristone, 200mg, was much safer for patients and resulted in similar outcomes, and that patients could take the followup dose of misoprostol within 24-48 hours, at home. A followup evaluation to confirm the success of the abortion was still necessary. Furthermore, the drug can be effective for up to 70 days, not 49.
In 47 states, that's what care providers started doing — off-label uses of drugs happen all over the country, every day, and the FDA is perfectly aware of it. In fact, when it sees consistent trends in off-label uses, this can be a signal that drug companies need to reevaluate and submit what's called a supplemental application, which is exactly what happened with Mifeprex. The FDA agreed that it was safe to adjust the medication's label, based on medical evidence, and set out new guidelines in line with those already in use in 47 states.
More access to medication abortion options is a good thing, because this is the least invasive method of first-trimester abortion and it's extremely safe and easy to administer. In regions without abortion providers, it can be used in telemedicine abortion, which frustratingly isn't readily available in most of the country though researchers have found that patient outcomes are comparable to those seen with in-person abortions.
Perhaps most critically, it creates the lowest cost burden on patients. Surgical abortions can be extremely expensive — up to $1,500 in the first trimester — in contrast with about $483 for medication abortion, which is still quite costly. However, patients won't need to make three separate clinic visits now, which reduces the need to take time off work and potentially spend hours driving to a provider. Furthermore, the lower dose means fewer side effects and an even lower risk of complications, so they'll be back to work, and parenting (60 percent of abortion patients already have children), and going to school much more quickly. Lowering financial barriers to abortion access is a critical component of protecting abortion rights, because liberally available abortion isn't helpful if no one can afford it.
Fuel for anti-abortion fires
Unsurprisingly, abortion opponents are upset by the ruling. Remember Ohio, Texas, and North Dakota? They all had laws on the books requiring physicians to abide by the outdated FDA guidelines, insisting that they only use the drug precisely as described on the label. This is quite unusual, as such restrictions don't exist for other off-label uses, and it's another instance of directly meddling not just in abortion access, but in how providers perform procedures and administer abortion care.
Physicians are the ones best trained to make decisions about how to approach an individual patient's case, but these states have passed legislation specifically telling them how to do their jobs, including mandatory ultrasounds, forcing providers to narrate ultrasounds to patients, and the like, though some of these bills have been successfully struck down. Of note is the fact that in 2014, researchers found that being forced to undergo and view an ultrasound had absolutely no impact on abortion decisions. None.
Together with targeted regulation of abortion providers (TRAP) laws, this legislation has choked out abortion clinics and access to reproductive health care in general. Including, ironically, pregnancy care and fertility treatments.
In these three states, accessing medication abortion — a common, cost-effective, less intrusive form of abortion — was extremely difficult thanks to their restrictive legislation, which was precisely the point. Now, doctors can still comply with the law, following the FDA's recommendations to the letter, but they'll be able to provide medication abortion services to more patients. This is undoubtedly sending legislators racing to their desks to find new and creative ways to make it difficult to access abortion.
The anti-choice groups were certainly quick out of the gate with their responses. National Right to Life Director of Education and Research Randall K. O’Bannon, Ph.D. has this to say about the new guidelines:
Certainly, none of the modifications is [sic] of any benefit to the unborn child...it is obvious that the FDA’s new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient.
Sometimes reproductive justice feels like a game of chess, played with real lives and very high stakes, whether we're talking about the right to parent, the need to access routine gynecological care, availability of contraceptives, sexual education, or abortion. When policy shifts like this happen, the right reacts almost instantaneously, endangering patients and providers alike with more restrictions on what should be, ultimately, a discussion between physician and patient. While the right cannot roll back the FDA's label, though it might wish it could, it will likely be looking for new ways to poke holes in abortion access to compensate, and we will be back to the same chess square we were on before.
This is why participating in elections is so important, and I'm not just talking about federal elections, which determine things like who gets to appoint the Surgeon General and the head of the FDA, and who gets to pass federal legislation that could have a huge impact on reproductive rights. It's also about local elections — who fills your state house, who occupies the governor's mansion and appoints state officials, who sits on the bench and decides legal cases that have an important bearing on reproductive rights. It's even about who you elect as mayor or county supervisor — let's not forget that Bernie Sanders' political career started out with a mayoral office, and now he's a major contender for the presidency of the United States.
Photo: ann harkness/Creative Commons