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An Update on Abortion Pills From the World Health Organization Undermines How the U.S. Regulates Them

The update may make mifepristone and misoprostol more readily available worldwide. But in the U.S., not much is expected to change.
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The abortion drug Mifepristone, also known as RU486.

The WHO has considered mifepristone and misoprostol "essential medicines" for more than a decade.

Abortion pills should be widely available and affordable, and don't need to be dispensed by highly trained specialists or in specialty facilities, according to a World Health Organization update published last week.

Abortions induced by taking pills are the safest type available. The recommended regimen is two pills, containing the drugs mifepristone and misoprostol. The pills work best on early stage pregnancies, around 10 weeks' gestation or less. The WHO has considered mifepristone and misoprostol "essential medicines" since 2005, but in the recent update, WHO experts decided that they had enough scientific evidence to strike the caveat saying the medications require "close medical supervision."

The change puts the United States' strict regulations around abortion pills even further out of step with international guidelines, activists and scientists say. The WHO update isn't legally binding, but many countries take the WHO essential medicines list seriously, so it may make mifepristone and misoprostol more readily available worldwide. In the U.S., however, not much is expected to change.

"It does improve the situation for everyone in the world because it increases the likelihood of nations making these drugs available," says Sara Ainsworth, legal director for If/When/How, a legal advocacy group that works on reproductive rights. In the U.S., however, she says: "We have political, not scientific, restrictions, placed on how prescribers can distribute the drug mifepristone. Unfortunately, the way that politics work, I don't know if the shift will mean that change [to how the U.S. regulates mifepristone] happens sooner."

Rebecca Oas, associate research director for the pro-life Center for Family and Human Rights (C-Fam), agrees that Americans likely won't see their access to abortion pills change because of the WHO update. "In the U.S., we rely much more on our structures, our own laws. We have a very robust FDA," she says.

The Food and Drug Administration first approved mifepristone for early abortions in 2000, with some limits on how it could be distributed. In 2011, the agency put the drug under a special protocol, called a risk evaluation and mitigation strategy, or REMS, that's common for riskier medicines. (Misoprostol, the second drug in the two-pill abortifacient combination, is not under a REMS.) The FDA has made some changes to mifepristone's REMS since 2011, but certain restrictions still stand, including that only certified hospitals and doctors' offices can dispense the pills; patients can't pick them up at a pharmacy. Certain states regulate the pills even more tightly than the FDA requires, for example mandating that only doctors oversee medication abortions, excluding physicians' assistants and nurse practitioners.

Scientists have long argued that mifepristone's REMS is unnecessary. "I think we're behind the times in the way that medication abortion is so heavily regulated here in the U.S.," says Daniel Grossman, director of a reproductive health science group at the University of California–San Francisco. For example, the WHO recommended in a guideline in 2015 that pharmacists should be able to dispense mifepristone and misoprostol to people who have a prescription, just like they do any other prescription drug. When asked about the most important studies demonstrating what level of medical supervision is needed for people to take abortion pills safely, a team of reproductive health researchers from the Netherlands sent me a study that followed 1,000 women who had gotten mifepristone and misoprostol after consulting with a doctor online, and then took the pills at home. The rates of complications among these home abortions were either similar to those among clinic-supervised medication abortions, or higher, but still low. For example, less than one-tenth of 1 percent of patients who received a medication abortion at a Planned Parenthood clinic needed a blood transfusion in 2009 and 2010. Among home pill-takers, that rate was a bit less than 1 percent.*

Oas, the research director for C-Fam, opposes what both pro-life and pro-choice groups characterize as the "de-medicalization" of abortion pills. "You're potentially creating higher levels of access, but you're doing it at the cost of certain medical safeguards that have existed, historically, to protect women's health," Oas says. She also worries about the possibility that, in a world where where abortion pills are easy to order without medical supervision, abusive partners could obtain them and slip them to their partners, who want to keep their pregnancies. At least a couple of men have recently been arrested and sentenced for doing just that.

When I asked an FDA spokesperson for comment on criticisms of its mifepristone REMS, the Office for Media Affairs replied with an email saying, "the REMS is necessary to ensure the safe use of Mifeprex." Mifeprex is the brand name for mifepristone. The office also sent along an informational webpage on mifepristone that states its possible serious side effects, including bleeding that's so heavy, it must be treated in a clinic. The page says that the FDA has received reports of 24 Americans dying after taking mifepristone, but the agency doesn't determine whether the medication caused those deaths. A few of the deaths seemed clearly unrelated, including two homicides, one suspected homicide, and one overdose on methadone, a prescription opioid.

The U.S.'s regulation of mifepristone makes abortion pills less available to Americans than they might be otherwise. In 2016 and 2017, Grossman surveyed 655 American gynecologists. More than 100 of them said they didn't provide medication abortions in their practice, but would, if they could just write a prescription and send their patients to a pharmacy to get the medication. Earlier this year, the FDA sent a warning letter to Aid Access, a service that allows people who want an early abortion to receive a consultation from a doctor online, and then get pills through the mail. Aid Access' founder, physician Rebecca Gomperts, told The Atlantic in October of 2018 that she had sent about 600 pill packages to U.S. patients over the preceding six months. The FDA ordered Aid Access to stop serving U.S.-based patients.

"You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others)," reads the FDA's website for mifepristone. Grossman considers Internet-ordered abortion pills relatively safe, from a health standpoint, although he notes that pills from sketchy websites that don't require any medical screening may not be strong enough to work properly. There also might be some legal risk to taking these pills, depending on state laws.

The new WHO classification of mifepristone-misoprostol seems to fall in line with other work the organization has done in recent years to encourage countries to make legal, safe abortions available. The organization argues that legal abortions help prevent abortion-related injuries and deaths. In 2014, the WHO estimated that 25 million unsafe abortions occur across the globe every year, the large majority of them in developing countries. Unsafe procedures can lead to infections, hemorrhaging, and damage to the vagina and uterus. Bad abortions cause about one in nine deaths among pregnant women and new mothers worldwide, the WHO estimates.

In 2015, the organization published a guideline outlining exactly how much training health-care workers need to safely perform various tasks related to providing abortions. Allowing lower-level workers, such as nurses and midwives, to take on as many tasks as possible helps increase access to abortions in areas where doctors are scarce, the WHO argued.

C-Fam opposes the WHO's approach altogether. "We would want WHO to respect the laws and customs of countries, when it comes to this area. To the extent that their policies prioritize access over law and over women's health, that's certainly something we would wish to see changed," Oas says. "We would like to see the WHO revise its operating procedures to treat pregnancies as two-patient situations, where what we want is a positive outcome for both." In the U.S., at least, there is a big debate about whether the health of fetuses should be protected by law.

Still, the World Health Organization is not as liberal as some would like. If you look up mifepristone-misoprostol in the WHO's "essential medicines" list, you'll see it comes with a note, unique among the 460 drugs there: "Where permitted under national law and where culturally appropriate."

Many advocates would like to see that phrase deleted.

"Conditional use dependent on national law and cultural acceptability risks offering a loophole to governments wary of embracing medical abortion," Lucía Berro Pizzarossa, a researcher at the Global Health Law Groningen Research Centre in the Netherlands, writes in an email. "These qualifications give states excuses to, for example, target organizations such as Aid Access that provide the medicines online."

"It's actually quite puzzling to me how a medicine can be, on the one hand, essential for public health, but only where abortion is legal or culturally acceptable," says Shannon Kowalski, director of advocacy for the International Women's Health Coalition.

The science around the safety of medication abortions, even with lesser levels of supervision, is firming up. The WHO update is a sign of that. But it seems that the cultural opposition to the procedure remains unmoved.

*Update—July 15th, 2019: This post has been updated with Daniel Grossman's correct title.