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Friday, July 5, 2024

Virtual Clinics Have a Backup Plan: Misoprostol-Only Abortions

After conflicting legal rulings triggered widespread uncertainty about the future of abortion pill access in the United States, both US-based telehealth providers and overseas pill-by-mail sellers want to make one thing clear: They’re here to stay.

Since the US Supreme Court overturned Roe v. Wade, virtual abortion clinics have taken a more prominent role in reproductive health care. Before that decision, virtual abortion clinics accounted for 4 percent of abortions in the US; after the decision, the number rose to 11 percent, according to a study from the Society of Family Planning. 

The ground shifted for abortion pill providers on April 8, when a ruling from Judge Matthew Kacsmaryk of the Northern District of Texas invalidated the US Food and Drug Administration’s approval of mifepristone, one of the two drugs commonly used in a two-step medication abortion. The ruling ignored decades of scientific consensus about mifepristone’s safety and undermined the FDA’s decades-old approval of the medication. It also directly conflicted with a ruling made the same day by Judge Thomas Rice of the Eastern District of Washington, directing US authorities to preserve access to the medication. 

Wednesday, the Fifth Circuit Court of Appeals partly overruled Kacsmaryk, ordering that mifepristone remain legally available—but it also overturned mifepristone dispensation by mail in states where it was previously legal. The ruling states that the drug must now be dispensed in person, undoing recent changes the FDA made to ensure people can access health care. 

This reversal impacts a wide network of telehealth providers. During the pandemic, when the FDA eased restrictions around virtual abortion care, abortion pills became available by mail in 25 states and Washington, DC. Many of these pills were provided by services specifically devoted to reproductive telehealth, including virtual clinics like Hey Jane and Choix. 

These companies have been preparing for increased restrictions and are now moving quickly to ensure they’re still able to legally operate without pause. As of now, both Hey Jane and Choix are continuing to offer mifepristone pills by mail in the states they were previously servicing. 

It’s unclear what might happen long-term if the mifepristone-by-mail ban stays, though. Even if virtual clinics want to keep dispensing the pills, they may run into an issue with the two major US manufacturers, Danco Laboratories and GenBioPro. “They would not give the pills to mail-order pharmacies to mail, unless the Biden administration issues an enforcement discretion notice, telling them that they're allowed to do that,” says Drexel University law professor David Cohen, referring to an FDA policy in which the agency does not take action against the dissemination of unapproved drugs if there are extenuating circumstances.

The FDA declined to comment on whether it would exercise enforcement discretion in regards to mifepristone-by-mail distribution. 

There are backup plans in place if mifepristone becomes unavailable for US telehealth providers. Medication abortions typically consist of two pills: mifepristone and misoprostol. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancies to continue. While mifepristone is often referred to colloquially as “the abortion pill,” it’s actually misoprostol that causes the uterine contractions that expel fetal tissue from the body. And as misoprostol is not subject to the recent rulings, there is a possibility that these companies will begin offering misoprostol on its own if manufacturers cut off access to mifepristone. This is not ideal, as the combination of pills produces the best results; misoprostol on its own can cause additional cramping and nausea. But for providers determined to keep helping patients, it’s better than nothing. 

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“We are prepared with the misoprostol-only protocol, should we need to go that route,” says Hey Jane cofounder and CEO Kiki Freedman. “It’s also very effective and very safe.”

Even before the Kacsmaryk ruling, virtual abortion clinics were limited in how they could operate. In more than half the country, they were already not permitted to send the pills. This doesn’t mean that people in states like Louisiana and Texas aren’t having medical abortions, though. Although US-based virtual clinics can’t send pills by mail in states that ban their services, a large number of overseas abortion pill providers still send mifepristone and misoprostol all across the US. They operate outside of the formal health care system, in a legal gray zone. And they plan to continue sending mifepristone to people who need it in the United States. Aid Access, an organization led by Dutch doctor and abortion rights activist Rebecca Gomperts, is the most prominent of these overseas organizations. Gomperts says Aid Access is not planning to change anything, even in a worst-case scenario where legal access is further restricted. 

Other overseas organizations are also staying the course. “The court ruling is not really changing how we operate, except that we could see more requests,” says Billy Adams, the spokesperson for a collective of medical professionals and abortion activists known as PrivateEmma. Both Aid Access and PrivateEmma send pills manufactured in India to people who request them in the United States, after providing a virtual medical consultation. 

Even if there is a major uptick in requests to these overseas providers, it’s unlikely there will be a scarcity issue. “There’s no supply shortage of the medication,” says Elise Wells, cofounder of abortion advocacy group Plan C. In addition to groups like Aid Access and PrivateEmma, there is a wide variety of more money-minded online sellers, who usually do not offer any support services but simply ship pills for a fee; these sellers also often source their pills from India. Ordering and taking pills from these sellers is not without risk. There’s no quality control to ensure the pills aren’t counterfeit, for starters. And while Gomperts says it’s “very rare” for packages that Aid Access sends to be intercepted, overseas mifepristone does occasionally get confiscated. Still, many people who cannot access legal abortion pills in the United States decide that these risks are worth taking.

While overseas providers brace for an uptick in people seeking abortion pills, the US telehealth providers remain optimistic that they will persevere. 

“I do not view this as an existential threat,” Freedman says. “There are many ways for us to continue providing safe and effective care to our patients. And we are confident that we will be able to continue doing so after this week.” 

The day after the Fifth Circuit’s decision was announced, a banner appeared at the top of Hey Jane’s website. It reads: Medication abortion is extremely safe, effective, and still legally available through Hey Jane.Update 4-12-2023 7:35 pm: This story was updated to correct the spelling of Kiki Freedman's name.

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