Imagine that you're pregnant, a few weeks in, and you decide you want an abortion. You walk into a retail pharmacy, and pick up a package on the shelf that says "medication abortion kit." You buy it and walk out, and end your early pregnancy at home.
"It's time that the general public understands that this could be a reality," says Dr. Daniel Grossman, part of the research team that published a study Monday in the journal JAMA Internal Medicine exploring this issue.
Over-the-counter abortion medication is not a reality currently. Grossman is not aware of any pending applications at the Food and Drug Administration for medication abortion to be sold over-the-counter. And in fact, there are more than a dozen states where abortion through any method and at any point of pregnancy is banned. Some of those states are pursuing court cases to curb access to the medication even further.
"There's so much discussion about the restrictions on medication abortion that are not evidence-based," says Grossman, director of Advancing New Standards in Reproductive Health at the University of California, San Francisco. He points to decades of research establishing the safety and efficacy of the two drugs used in medication abortion. "It's exciting to see science pointing us in another direction, where access could be expanded."
The study design
For this study, researchers surveyed 168 patients waiting to see a clinician to receive medication abortion. "If they were interested and eligible to participate in the study, they looked at a box that is kind of like a prototype packaging for what an over-the-counter medication abortion package might look like," explains Grossman. The box took them a long time to develop, he adds, explaining that they named the prototype "MiMi" for the two medications, mifepristone and misoprostol.
Based on the information on the box, patients assessed whether they would be good candidates for the medication. Then, researchers compared the patient's self-assessment to the assessment of the clinician they went on to see.
"We found that people did a really good job at self-assessing their eligibility," Grossman says. "Overall, 88% of participants had concordant answers, meaning that they had a self-assessment that said they were eligible and the clinician said they are eligible, or the patient said they were ineligible and the clinicians said they were ineligible."
Grossman acknowledges that the study size is small, and that the findings aren't very generalizable. "[It] is not going to be the definitive study that's going to convince the FDA to move this over-the-counter, but it does start to point in a direction to suggest that this might make scientific sense and it deserves further research," he says.
Growing evidence
In accompanying commentary in JAMA Internal Medicine, Dr. Sonya Borrero of the University of Pittsburgh School of Medicine writes that the research "adds to a growing, policy-relevant evidence base supporting OTC access to medication abortion."
She adds, however, "it is important to acknowledge that FDA decision-making around medication abortion may be influenced by the politicization of reproductive health care, such that scientific evidence may compete with ideological and legal pressures in shaping regulatory outcomes."
For Julie Maslowsky, a developmental psychologist and population health scientist who studies sexual and reproductive health at the University of Michigan, the findings of the study were not surprising at all.
"I think what's important to recognize here is that the scenario that they tested is not very different from what is currently happening in clinical practice in many cases," she says. "Many people are accessing medication abortion through telemedicine models, meaning that they are interacting with a clinician remotely in order to obtain the medications, that they have received quite a bit of information about the medications prior to an appointment, and that they are then taking the medications on their own at home."
She asserts these medications would meet the safety and efficacy criteria for FDA to make them available over-the-counter. She also says that would represent an "incremental change" from current availability in states where abortion is legal.
If it seems like a radical idea, that "may have to do with the fact that reproductive health is highly stigmatized in our society," she says. Actually in terms of how the drugs work in the body, she says, "it can be comparable to many other over-the-counter switches that the FDA has overseen."
The political moment
Again, an over-the-counter medication abortion kit does not yet exist. And it's hard to imagine in the current political context.
President Trump has appeared unmotivated in his second term to act on abortion, but Republicans in Congress who oppose abortion have begun to be more aggressive in recent weeks. Sen. Josh Hawley, R.-Mo., introduced a bill to remove the full approval of mifepristone, and Sen. Bill Cassidy, R.-La. announced an investigation into the drugmakers behind mifepristone.
"How did we get here?" Cassidy, a physician and chair of the health committee, asked in a Senate hearing on mifepristone's safety in January. "To the point where abortion pills can be ordered online, mailed, taken with no medical supervision and we have no safeguards against coercion."
He added that people should "not normalize a procedure whose intent is to end a life."
Louisiana actually scheduled mifepristone as a controlled substance and criminally indicted an out-of-state physician who prescribes abortion pills via telemedicine. A court case currently before a federal judge there would restore an in-person appointment requirement for mifepristone nationally, which would end telehealth access to the medication all over the country.
The FDA is also doing a new safety review of mifepristone, prompted by anti-abortion rights groups and lawmakers. According to an FAQ on the agency's website updated in February: "We are planning to complete the study as soon as possible while ensuring we are not cutting any corners from a scientific research standpoint."
Given all of this, Grossman says that "it's probably not the right political moment to submit an application before the FDA" for over-the-counter approval.
"A long road"
As for how — despite the political headwinds — over-the-counter medication abortion might come to exist, Grossman draws lessons from the process of FDA approving an over-the-counter birth control pill in 2023.
"It was a long road to get there, and part of that road involved doing research early on to show that people were interested in an over-the-counter birth control pill, that they could figure out on their own whether it was right for them," he says. "That work was important to get a pharmaceutical company interested in this as a possibility, and to start sensitizing the FDA that this wasn't a crazy idea and that the evidence again really pointed toward the safety and effectiveness of over-the-counter access."
When it comes to medication abortion, "the next step, if a pharmaceutical company was going to try and take on this over-the-counter switch, would be they would do these actual use studies, which means that they make the drug available, people actually use it, and then they track appropriateness of use and any outcomes," Maslowsky explains. "Those are very expensive, complicated studies to do."
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