After legal disputes failures triggered widespread uncertainty about the future of access to the abortion pill In the United States, both US-based telehealth providers and foreign mail-order pill sellers want to make one thing clear: They are here to stay.
From the Supreme Court of the United States struck down Roe vs. Wade, virtual abortion clinics have assumed 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 of the Family Planning Society.
The playing field changed for abortion pill providers on April 8, when a ruling by Judge Matthew Kacsmaryk of the Northern District of Texas invalidated the US Food and Drug Administration’s approval of mifepristone, one of the two medications commonly used in a two-step medical abortion. The ruling ignored decades of scientific consensus on the safety of mifepristone and undermined FDA approval of the drug for decades. It also directly conflicted with a ruling issued the same day by Judge Thomas Rice of the Eastern District of Washington, which ordered US authorities to preserve access to the drug.
Wednesday, the Court of Appeals for the Fifth Circuit partially canceled Kacsmaryk, ordering that mifepristone remain legally available, but also rescinding the dispensing of mifepristone by mail in states where it was previously legal. The ruling states that the drug must now be dispensed in person, overturning recent changes the FDA made to ensure people can access health care.
This rollback affects a wide network of telehealth providers. During the pandemic, when the FDA eased restrictions around virtual abortion care, abortion pills became available by mail order in 25 states and Washington, DC. Many of these pills were provided by services specifically dedicated to reproductive telehealth, including virtual clinics like Hey Jane and Choix.
These companies have been preparing for further restrictions and are now moving quickly to ensure they can still legally operate without pause. From now on both hello jane and Choix continue to offer mifepristone pills by mail order in the states they previously served.
However, it is not clear what might happen in the long term if the ban on mifepristone by mail is upheld. Even if the virtual clinics want to keep dispensing the pills, they may run into trouble with the two major US manufacturers, Danco Laboratories and GenBioPro. “They wouldn’t give the pills to mail-order pharmacies to mail out unless the Biden administration issues a notice of enforcement discretion, telling them they can,” says Drexel University law professor , David Cohen, referring to an FDA policy. in which the agency does not take action against the spread of unapproved drugs if there are extenuating circumstances.
The FDA declined to comment on whether it would exercise enforcement discretion regarding the distribution of mifepristone by mail.
Backup plans are in place in case mifepristone is not available to US telehealth providers. Medical abortions generally 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 colloquially referred to as “the abortion pill,” it is actually the misoprostol that causes the uterine contractions that expel fetal tissue from the body. And since misoprostol isn’t subject to the recent rulings, there’s a chance these companies might start offering misoprostol only if manufacturers cut off access to mifepristone. This is not ideal, since the combination of pills produces the best results; misoprostol alone can cause additional cramping and nausea. But for providers determined to keep helping patients, it’s better than nothing.