Mifepristone is one of the two drugs that make up what’s called a medication abortion, a non-surgical abortion that patients can have early in a pregnancy. The Food and Drug Administration (FDA) approved it for use under the commercial name Mifeprex back in 2000. Here’s how it works, from the experts at Planned Parenthood:
The “abortion pill” is the common name in the United States for using two different medications—mifepristone and misoprostol—to end an early pregnancy. In general, it is used up to 70 days, or 10 weeks, after the first day of your last menstrual period.
- Mifepristone works by blocking the hormone progesterone. Without progesterone, the lining of the uterus breaks down and the pregnancy cannot continue.
- Misoprostol, the second medication, is taken either right away or up to 48 hours later and causes the uterus to empty. It’s like having a heavy, crampy period and is very similar to an early miscarriage.
Medication abortion is extremely effective in ending an early pregnancy, working approximately 95-99% of the time, and gives patients the option to end their pregnancy at home or in another setting in which they feel comfortable, while still providing them with the medical support and information they need.
Medication abortions have become more common; In 2014, one out of every three abortions performed outside a hospital setting were self-managed, and the percentage is almost certainly higher now, given the COVID-19 pandemic. In other words, mifepristone is widely used, and we know a lot about how it works.
So what’s the problem? The problem is that the FDA makes it much harder for patients to get mifepristone than it should. Furthermore, the barriers to medication abortion that the FDA has built have no scientific or evidentiary basis. By every indication, it appears the motivation for their creation was purely political. Restrictions on distribution date back to 2000, when the FDA first approved the drug, as a concession to anti-abortion rights forces: As pro-choice activists wrote in an essay for The New York Times in June, “because of opposition to abortion, mifepristone is as heavily regulated as drugs like OxyContin.”
According to FDA regulations, patients can only receive mifepristone directly from a licensed health care provider (a physician, nurse practitioner, nurse midwife, or physician assistant) during an in-person visit, and even then only if that provider is specifically registered to distribute mifepristone. Normally, if one has a license to practice medicine, one has a license to, well, practice medicine—without jumping through extra hoops based on wholly specious grounds. Additionally, mifepristone cannot be prescribed and picked up at a pharmacy. Because this drug is also helpful for those who suffer a miscarriage, mifepristone restrictions needlessly harm people who do not seek medication abortion.
The FDA regulates mifepristone this way under a program known as Risk Evaluation and Mitigation Strategies (REMS). The REMS restrictions, per Planned Parenthood, “severely limit patients’ access” to vitally needed health care. The organization also stated: “Because they’re not supported by medical science, leading medical associations—including the American College of Obstetricians and Gynecologists and American Academy of Family Physicians—support removing REMS restrictions on mifepristone entirely.”
Previously published research articles, as well as new pieces published in the most recent issue of the peer-reviewed medical journal Contraception—in a special issue devoted to examining the need to revise the mifepristone REMS—provide clear evidence about self-managed abortions carried out through telemedicine, with mifepristone delivered by mail: “The weight of medical and public health evidence demonstrates that mifepristone is extremely safe and the REMS are unnecessary. In fact, the mifepristone REMS is neither justified by the absolute risk of the medication itself, nor comprehensible as a logical response to the risks actually posed by mifepristone.”
A recent Contraception articles explains that removing the REMS-related barriers to distributing mifepristone would increase the number of medication abortion providers by 100%, with the largest impact being seen in regions that currently lack adequate numbers of providers. Another article examines the “disproportionate burdens” felt by lower-income Americans (who make up 75% of those who need abortion care in the U.S.) and BIPOC (60% of those who need such care), thanks to the restrictions placed on mifepristone. Yet another article focuses on the impact these limitations have on Native American patients specifically, and notes that “difficulties in acquiring the drug [cause] delays for Indian Health Service and Tribal facilities attempting to utilize the medication.” Another article lays out the case for why pharmacists with proper training should also be authorized to distribute mifepristone with a prescription.
It’s worth noting that other oral drugs that have the REMS designation are not restricted to in-person distribution. Mifepristone is safer than Viagra or penicillin, yet only the one that has something with abortion gets stuck with the REMS label. Anticoagulants don’t have such a label either, and their associated risk of bleeding is very similar to that of mifepristone. The way mifepristone is treated—differently and with a degree of scrutiny not supported by evidence—reflects what is known as “abortion exceptionalism.” One article in Conception explores abortion exceptionalism and the constraints on mifepristone in depth. We can also see this negative form of exceptionalism in bogus TRAP (targeted restrictions on abortion providers) laws that, as Planned Parenthood has documented, are “costly, severe, and medically unnecessary requirements imposed on abortion providers and women’s health centers.”
Activists have been long fighting to remove the barriers to accessing mifepristone, and the pendulum has swung back and forth enough times in just the past 12 months to make one dizzy. In July 2020, in response to a lawsuit filed by the ACLU, a federal court blocked the restrictions requiring in-person distribution of mifepristone during the pandemic—which, unsurprisingly, The Man Who Lost an Election and Tried to Steal It had refused to lift.
But in January of this year, the Supreme Court ruled that Trump could reinstate the in-person requirement. In her precise and passionately argued dissent, Justice Sonia Sotomayor pointed out that “this country’s laws have long singled out abortions for more onerous treatment than other medical procedures that carry similar or greater risks.” She continued:
Maintaining the FDA’s in-person requirements for mifepristone during the pandemic not only treats abortion exceptionally, it imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose. One can only hope that the Government will reconsider and exhibit greater care and empathy for women seeking some measure of control over their health and reproductive lives in these unsettling times.
With COVID-19, of course, anything we can do to limit unnecessary in-person interactions, including travel—especially long-distance trips when the closest abortion provider is far away, as is often the case in the so-called “abortion deserts” that exist in red states and rural areas—is a plus for the health of our communities.
Another plus for the health of our communities was the inauguration of the Biden-Harris administration. In one of the least surprising of developments, Joe Biden is light years better than the twice-impeached former guy on women’s rights and reproductive freedom. He took action on that front in the first week of his presidency.
In April, Biden’s FDA issued a pronouncement once again temporarily removing the reimposed restrictions on mifepristone. Dr. Daniel Grossman, who runs Advancing New Standards in Reproductive Health, a research organization at the University of California San Francisco, expressed strong approval: “Today’s FDA announcement is a step in the right direction and means that patients won’t have to risk their health during the pandemic to get abortion care.”
Jen Villavicencio, a health policy fellow with the American College of Obstetricians and Gynecologists, also responded positively, and reminded us that mifepristone “has very few risks at all.” Villavicencio added: “It is more safe than over-the-counter medications like ibuprofen and Tylenol. We know this medication can be safely administered via telemedicine because we’ve studied it.”
As part of the announcement in April, Acting FDA Commissioner Dr. Janet Woodcock noted that research studies “do not appear to show increases in serious safety concerns occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.” Today, the goal is to make sure that the restrictions don’t come back once the pandemic subsides, given that there’s no medical justification for them in the first place. As National Women’s Health Network executive director Cynthia A. Pearson proclaimed: “We must now fight to make this change permanent, and to lift all medically unnecessary restrictions on medication abortion during the pandemic and beyond.” Even now, with the changes made in April, mifepristone still cannot be distributed by pharmacies—only by medical providers.
I interviewed Dr. Gillian Dean, Senior Director of Medical Services at Planned Parenthood Federation of America, about this issue. Let’s start with her overarching thoughts:
We have long known the decades-old REMS restrictions on mifepristone are medically unnecessary and only serve to harm patients’ ability to access safe, timely abortion. During the COVID-19 pandemic, [these restrictions] have become even more dangerous, as patients, health care providers, and health center staff have had to risk their health and safety just to obtain or provide time-sensitive, essential health care.
Dr. Dean highlighted how harmful the limits on mifepristone distribution were, to the most vulnerable patients in particular.
Forcing patients to unnecessarily travel to a health center to access the safe, effective medication they need is especially harmful to people of color, people with low incomes, and those living at the intersection of these identities. These are the same communities that already face greater barriers to care, are more likely to live in medically underserved areas, and suffer from higher rates of illness, death, and economic difficulties due to COVID-19.
During a public health crisis, people need more access to time-sensitive health care, not less. Burdensome restrictions on medication abortion deepen the health inequities already experienced by those struggling to make ends meet—particularly people of color, people in rural areas, and people with low incomes—who comprise a majority of medication abortion patients and who are being harmed most by the devastating effects of the pandemic.
Finally, Dr. Dean also provided a fact that further highlights how this medication’s treatment exemplifies abortion exceptionalism: “Out of 20,000 prescription medications regulated by the FDA, mifepristone is the only one the FDA requires to be dispensed in-person, but permits patients to self-administer at home.”
The FDA needs to treat mifepristone like it’s supposed to treat any other medicine—based on the science, not the politics. For too long, anti-choice zealots have falsely claimed that mifepristone’s place in the REMS program means that taking it comes with “life-threatening risks.” More broadly, the right-wing Family Research Council (FRC) has for decades flung lies about mifepristone and self-managed abortion, using what Carrie N. Baker, a professor of women and gender studies at Smith College, described as “discredited research and junk science, making the false claim that abortion causes depression, and then claim[ing], without evidence, that medication abortion is “uniquely traumatic.”
In May, shortly after the temporary, COVID-19-driven lift of mifepristone restrictions, the FDA undertook a full review. According to their procedures, to make a permanent change, they would have to make a determination that “that the extra measures in a REMS are no longer necessary to ensure a medication’s benefits outweigh its risks.” If the White House listens to the science, rather than the inevitable outcry from forced birthers, we should see a statement along those lines announced in the relatively near future. If that happens, reproductive rights activists, along with the ACLU—who filed a lawsuit seeking to overturn the restrictions—deserve a great deal of credit.
Yet in the 19 states that ban telemedicine for medication abortions, nothing the FDA does can directly affect those laws, although a clear statement—that such abortions do not pose the kinds of risks incorrectly associated with a REMS designation—would absolutely help in that struggle. Those fighting for reproductive freedom will have to continue to battle in legislative chambers at the state and federal level—where Democrats are making a serious push this year to achieve the decades-old goal of blocking the Hyde Amendment that restricts federal money from being spent on abortion. However, that depends on the Senate going along with House Democrats, which seems an iffy proposition at this point.
The push to restrict mifepristone access connects to the many elements within the anti-choice agenda, like TRAP laws, that claim to protect patients’ health but in reality seek only to restrict abortion access. The temporary pandemic rules allowing providers to see patients virtually and dispense mifepristone through the mail should be made permanent, and there’s also no reason why providers shouldn’t be able to prescribe the medicine, allowing patients to get it from their local pharmacy. The president and the FDA must listen to the science, which supports removing unjustified restrictions on mifepristone.
The Biden FDA permanently eliminating the restrictions on mifepristone would not solve all the problems relating to abortion access, many of which derive from socio-economic, regional, and racial disparities. As Dr. Dean told me, “systemic barriers to abortion care existed long before the pandemic and will continue to exist long after.” While we must also contend with the straightforward legislative efforts to restrict or essentially ban the procedure, changing the rules on this medication would absolutely increase access on a wide scale.
Every victory brings us one step closer to achieving the goal of gender equality and reproductive freedom for all Americans.
Ian Reifowitz is the author of The Tribalization of Politics: How Rush Limbaugh’s Race-Baiting Rhetoric on the Obama Presidency Paved the Way for Trump (Foreword by Markos Moulitsas)