New year, same as the old year: Republicans in statehouses across the country followed January 2016’s 147 anti-choice bills with a record-breaking 167 anti-choice bills introduced in the first month of 2017. Among those bills is a spate of proposals aiming to limit access to medication abortion. While nearly every aspect of abortion care is threatened, the multifaceted attack on medication abortion is particularly troubling in light of last year’s Food and Drug Administration (FDA) update to the label of the medication abortion drug Mifeprex, and a recent New England Journal of Medicine commentary that explains how the update barely scratched the surface of needed changes.
The ten authors—a multidisciplinary group of clinicians, public health and legal experts, and researchers—of “Sixteen Years of Overregulation: Time to Unburden Mifeprex” detailed the ways in which the ongoing over-regulation of Mifeprex is not just unnecessary, but harmful to patients considering or seeking medication abortion.
The new label introduced a host of changes for Mifeprex use, including new dosages and an important revision that allows it to be administered later into pregnancy. These changes are expected to “reduce confusion among women, providers, and policymakers about the appropriate use of the drug,” according to the authors, who also anticipate abortion becoming “less expensive, more convenient, and more widely available.” When used with the drug misoprostol, mifepristone is a very effective and safe way to end an early pregnancy.
But the drug is still restricted through what’s called the Risk Evaluation and Mitigation Strategy (REMS). These are additional rules implemented through the federal Food, Drug, and Cosmetic Act (FDCA) when the Food and Drug Administration suspects a drug has serious adverse effects. Mifeprex’s REMS regulations determine where, how, and by whom the medication can be prescribed and administered—despite its proven efficacy and safety. The drug cannot be sold at pharmacies and must be dispensed by a certified prescriber in a clinic, medical office, or hospital. To become “certified,” a physician must submit a form to the drug’s maker declaring that he or she can date a pregnancy, diagnose ectopic pregnancy, and provide surgical intervention if needed, either personally or by referral. All of this, of course, adds additional hurdles for the patient and provider.
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“The REMS places medically unnecessary burdens on patients and providers, and keeps mifepristone [the generic name of Mifeprex] from being prescribed by clinicians and then obtained in retail or mail-order pharmacies, alongside hundreds of other medications,” said Dr. Beverly Winikoff, president of Gynuity Health Projects. “The negative impact from over-regulation of medical abortion with the REMS, like other abortion restrictions, can fall hardest on poor women, rural women, women of color, undocumented women, and young women.”
Winikoff told Rewire that the growing percentage of patients who choose Mifeprex as their preferred abortion method—from 6 percent of all abortions in 2001 to 31 percent in 2014 and nearly half of those before nine weeks’ gestation—means that the REMS restrictions affect a significant number of people.
Thirty-seven states currently have medication abortion restrictions on the books. Six, like Oklahoma’s outright ban on medication abortion, are temporarily or permanently enjoined by court order. Oklahoma’s legislature is doubling down by introducing new legislation to make a violation a felony with a possible $100,000 fine and attempting to reduce the window patients have to access abortion altogether to six short weeks. Oklahoma’s fixation on medication abortion isn’t an outlier; a full 15 percent of the 288 abortion-restricting laws passed from 2011 to 2015 concerned medication abortion.
Having official federal restrictions like REMS lends credibility to these legislative efforts.
“It’s unconscionable that the REMS restrictions remain after 16 years of data showing mifepristone is an exceedingly safe and effective abortion method,” said Winikoff. “The restrictions on mifepristone are a shameful example of regulation run amok—and they’re harming women’s health. Women and their health providers shouldn’t have to jump through hoops to get a medication that’s been safely and effectively used in this country for a decade and a half.”
The commentary’s authors also point out the contradictions between the purpose of REMS (public safety) and unnecessary regulations. For example, there’s no risk of overdose when each patient only receives a single dose of Mifeprex. Also, even if there was a high rate of complication (mifepristone is less risky than over-the-counter pain relievers like Tylenol), requiring the medication to be taken in a doctor’s office wouldn’t prevent infection or bleeding.
“[T]he pharmacologic effects do not begin for hours after ingestion. If a serious complication were to occur, the location where the woman had obtained the tablets would be entirely irrelevant to her clinical outcome. In fact, recent research has shown that allowing each woman who has a medical abortion to take the mifepristone in the place of her choosing is safe and is preferred by many women.”
They also outlined other potential harm caused by requiring dispensing providers to have special certification. Being certified means creating a public record as an official abortion provider; the risk of harassment and threat can understandably discourage Mifeprex provision.
The hoops created by REMS are especially burdensome in rural America. For physicians outside urban settings, there is a greater risk of not being able to treat an unexpected patient because they are not certified and therefore are unable to stock the medication ahead of time—and being unable to refer a patient to another health-care provider. Where clinics have closed en masse, distances to the nearest provider can be hundreds of miles, and the availability and legality of telemedicine can’t be guaranteed due to legislative attacks. For example, the Utah Telehealth Amendments (HB 154) bill that just passed the state house would make medication abortion by telemedicine illegal except in cases of rape, incest, or threat to the life of the patient.
Cristina Aguilar, executive director of the Colorado Organization for Latina Opportunity and Reproductive Rights (COLOR), told Rewire about the importance of medication abortion in her state.
“In a rural state like Colorado, health care can be difficult for people to obtain,” she said. “Medication abortion is an option that many providers offer to expand access, including in smaller clinics outside of urban areas.”
In addition to attempting to put it literally out of reach, legislators are still advancing bills requiring doctors to tell their patients that medication abortion can be reversed—which is scientifically incorrect. Lawmakers in Colorado, Georgia, Indiana, North Carolina, and Utah have introduced “abortion reversal” bills like the ones in place in Arkansas and South Dakota (and successfully challenged in Arizona last year).
Aguilar connected “abortion reversal” with the history of medical experiments performed on marginalized communities.
“Looking at the so-called research on the idea of reversing medication abortion shows that this is a refuted theory based on the anecdotal experiences of physicians who were willing to do experimental treatment on pregnant women, without the usual research safeguards to protect their health and safety. Women of color have seen this before,” she said. “There is a long history of women of color being coerced and abused within the scientific and medical profession.”
SisterSong Executive Director Monica Simpson told Rewire that requiring doctors to lie to patients is bad medicine and a violation of trust.
“When women make a decision to have an abortion, they are clear about their decision and it should be respected. It’s cruel to tell women something that undermines their decision and isn’t even backed up by science.”
Simpson also echoed Winikoff’s concerns about who is most affected by these restrictions.
“When medication abortion is restricted, the most marginalized communities are most affected, those who are oppressed by systemic and historical barriers, including low-income folks, people of color, Black women, undocumented folks, young people,” said Simpson, stressing that abortion is an important part of reproductive health care in her community.
The experts cited social justice concerns like Simpson’s, agreeing that decisions on when and whether to parent should be left to the patient and the medical community’s best practices and that medication abortion restrictions impose harm. In their article, they said that the REMS requirements to “assure safe use plainly impede women’s access to the drug …. Considering the severe shortage of abortion providers in many parts of the United States and the long distances that many women must travel to obtain abortion services, we contend that any barrier to access that has no demonstrated benefit is excessive.”