Abortion pills would be safe even over-the-counter, a new study says : NPR

A coordinator with the Massachusetts Medication Abortion Access Project shows what the medication abortion kit prescribed and sent via telehealth looks like.

Charles Krupa/AP

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Charles Krupa/AP

Imagine you are pregnant a few weeks later and you decide you want to have an abortion. You walk into a retail pharmacy and pick up a package from the shelf that says “medical abortion kit.” You buy it, go and terminate your early pregnancy at home.

“It’s time for the general public to understand that this could be a reality,” says Dr. Daniel Grossman, a member of the research team that published a study Monday in the journal JAMA Internal Medicine exploring this question.

Over-the-counter abortion medications are not currently a reality. Grossman is not aware of any pending applications to the Food and Drug Administration for medical abortion to be sold over the counter. And in fact, there are more than a dozen states where abortion, any method and at any time during pregnancy, is prohibited. Some of these states are taking legal action to further restrict access to the drugs.

“There is so much discussion about restrictions on medical abortion that is not evidence-based,” says Grossman, director of Advancing New Standards in Reproductive Health at the University of California, San Francisco. It points to decades of research establishing the safety and effectiveness of the two drugs used in medical abortion. “It’s exciting to see the science pointing us in another direction, where access could be expanded.”

Study design

For this study, researchers interviewed 168 patients waiting to see a clinician to undergo a medical abortion. “If they were interested and eligible to participate in the study, they looked at a box that sort of looks like a prototype package of what an over-the-counter abortion medication package might look like,” Grossman says. Developing the box took them a long time, he adds, explaining that they named the prototype “MiMi” for the two drugs, mifepristone and misoprostol.

Based on the information on the box, patients rated whether they would be good candidates for the drug. Next, the researchers compared the patient’s self-assessment to that of the clinician they subsequently consulted.

“We found that people were doing a really good job of self-assessing their eligibility,” Grossman says. “Overall, 88% of participants had concordant responses, meaning they had a self-assessment that they were eligible and the clinician said they were eligible, or the patient said they were not eligible and the clinicians said they were not eligible.”

Grossman acknowledges that the study size is small and the results are not very generalizable. “[It] “This won’t be the definitive study that convinces the FDA to make this product available over-the-counter, but it begins to indicate that this might make scientific sense and merits further research,” he says.

Growing evidence

In an 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 over-the-counter access to medication abortion.”

She adds, however, “it is important to recognize that FDA decision-making regarding medical abortion may be influenced by the politicization of reproductive health care, such that scientific evidence may compete with ideological and legal pressures to shape regulatory outcomes.”

For Julie Maslowsky, a developmental psychologist and population health scientist who studies sexual and reproductive health at the University of Michigan, the study results weren’t at all surprising.

“I think it’s important to recognize here that the scenario they tested is not very different from what is currently happening in clinical practice in many cases,” she says. “Many people access medication abortion through telemedicine models, meaning they interact remotely with a clinician in order to obtain the medications, are provided with extensive information about the medications before an appointment, and then take the medications themselves at home.”

She says these drugs would meet the safety and effectiveness criteria allowing the FDA to make them available over the counter. She also says it would represent a “gradual change” from current availability in states where abortion is legal.

If this seems like a radical idea, it “may be because reproductive health is heavily stigmatized in our society,” she says. In fact, when it comes to how the drugs work in the body, she says, “it can be comparable to many other over-the-counter changes overseen by the FDA.”

The political moment

Again, there is no over-the-counter medical abortion kit yet. And it’s difficult to imagine in the current political context.

President Trump has appeared unmotivated during his second term to act on abortion, but congressional Republicans who oppose abortion have begun to be more aggressive in recent weeks. Sen. Josh Hawley, R.-Mo., introduced a bill to remove 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 chairman of the health committee, asked during a Senate hearing on the safety of mifepristone in January. “To the point where abortion pills can be ordered online, sent by mail, taken without medical supervision and we have no guarantee against coercion.”

He added that people should “not normalize a procedure whose purpose is to end a life.”

Louisiana actually classified mifepristone as a controlled substance and criminally charged a foreign doctor who prescribed abortion pills via telemedicine. A court case now before a federal judge would reinstate an in-person appointment requirement for mifepristone nationwide, ending telehealth access to the drug nationwide.

The FDA is also conducting a new safety review of mifepristone, at the request of abortion rights groups and lawmakers. According to an FAQ updated in February on the agency’s website: “We plan to complete the study as quickly as possible while ensuring that we do not skimp on anything from a scientific research perspective.”

Given all of this, Grossman says “it’s probably not the right political time to submit an application to the FDA” for over-the-counter approval.

“A long way”

As for how — despite political headwinds — over-the-counter medication abortion could exist, Grossman draws lessons from the FDA’s process of 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 determine for themselves whether it was right for them,” he says. “This work was important to interest a pharmaceutical company in this possibility and to begin to educate the FDA that this was not a crazy idea and that the evidence once again pointed to the safety and effectiveness of over-the-counter access.”

When it comes to medical abortion, “the next step, if a drug company was trying to get into this over-the-counter product shift, would be to do these actual use studies, meaning they make the drug available, people actually use it, and then they monitor the appropriateness of its use and its possible outcomes,” Maslowsky says. “These are very expensive and complicated studies to carry out.”