To Protect Access To Medication Abortion In The US, Make The Misoprostol-Only Regimen A Reality

Following the US Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision in late June overruling Roe v. Wade, the United States joins 126 countries around world in having a restrictive setting for abortion access. As of September 9, all or most abortions are already illegal in 12 states, legal only before six weeks in another two, and inaccessible in a 10 others. At least 10 more state-level bans are either on the way or temporarily blocked. Together, these laws leave many pregnant people without access to this vital health service. And despite limited legal, legislative, or administrative options available to respond to new restrictions, the Biden administration has made protecting medication abortion—the use of pills to terminate a pregnancy—one of their top priorities.

To realize this goal, US health officials, medical institutions, pharmaceutical companies, and advocates need to campaign for the support, registration, and authorization of a misoprostol-only regimen for medication abortion before 13 weeks of gestational age. Just as importantly, they must also allow the drug to be prescribed by pharmacists and dispensed at any pharmacy, particularly in states where abortion is available upon request.

These steps may sound unprecedented, but in reality they are aligned with international standards for existing clinical practices. The World Health Organization’s (WHO’s) latest abortion guidelines recommend a misoprostol-only regimen for terminating pregnancies before 13 weeks, based on the drug’s high efficacy and excellent safety profile. Surveys carried out in Africa, Asia, and Latin America show that pregnant people in both restrictive and non-restrictive environments regularly use pharmacy-prescribed and -dispensed misoprostol-only regimen.

Benefits Of A One-Drug Regimen For Medication Abortion

At present, the Food and Drug Administration (FDA) has only approved a combined regimen of misoprostol with the progesterone blocker mifepristone for medication abortion. Federal guidelines now allow the medications to be delivered by mail; however, 19 states still require that they be dispensed and administered in-person. Moreover, many states substantially limit the availability of the latter drug by requiring prescriptions from clinicians licensed by the drug’s manufacturer—a relatively small group. While experts argue that the in-person dispensing and administration policies are both unwarranted and unduly burdensome, and they face active legal challenges on those grounds, it is unlikely they will be rescinded in the near future. Additionally, using mifepristone is expensive: Uninsured patients pay an average of more than $500 for a medication abortion. (A single mifepristone pill costs around $90, with the remaining costs accruing from clinic visits, tests, and other processes.)

By contrast, the standard price for a misoprostol pill in the US is $2 to $5, or $8 to $20 for a full dose. The misoprostol regimen is also simpler. The current procedure involves one 200 mg oral dose of mifepristone followed 24–48 hours later by four 200 mg misoprostol pills taken buccally (meaning inside the cheek), sublingually, or vaginally. The misoprostol-only alternative only requires administration of the misoprostol pills.

These circumstances make misoprostol a more appealing option. It is simpler, cheaper, less burdensome, equally safe, and equally effective. It is widely used for medication abortion in many parts of the world and has been recognized as an essential medicine by the WHO since 2005 primarily for that reason.

Introducing a misoprostol-only regimen as an alternative for medication abortion and making it more widely accessible than the current mifepristone plus misoprostol regimen would expand choice and increase access to safe, self-administered, and reliable early-term medication abortions in the face of ongoing attacks on and restrictions of abortion rights.

Step 1: Authorize Misoprostol-Only Regimen For Medication Abortions

At present, the FDA has only approved misoprostol for treating gastric ulcers. The first step toward broadening access to medication abortion is for the FDA to approve misoprostol for terminating pregnancies. The drug has 10 major manufacturers, some combination of which must submit a New Drug Application to the FDA to secure approval for misoprostol as a stand-alone abortifacient.

This is eminently achievable. The misoprostol-only regimen has been in use internationally for decades. There is already a wealth of high-quality studies on the efficacy of misoprostol alone for abortion, including randomized controlled trials with large sample sizes from respected institutions. One recent meta-analysis of 42 studies (and more than 13,500 combined participants) showed that self-management of misoprostol-alone has high levels of effectiveness, with 93 percent to 99 percent of participants reporting complete abortion without the need for surgical intervention. Side effects are typically limited to cramping and bleeding, with more serious complications (for example, heavier bleeding ultimately requiring surgery to complete the abortion) being easy to detect at home and occurring in fewer than 0.2 percent of cases.

The growing use of medication abortion and the safety and efficacy of the misoprostol-only regimen indicate that the drug is ready for widespread use in the US. This large potential market of consumers seeking medication abortions should provide ample motivation for manufacturers to take the required steps.

Step 2: Allow Pharmacists To Prescribe And Dispense The Misoprostol-Only Regimen

The misoprostol-only regimen, like the combined mifepristone plus misoprostol regimen, can easily be taken at home. Given the safety and efficacy of medication abortions, the WHO recommends this option for medication abortions rather than taking the pills in a hospital or clinic to reduce burdens on health care systems. At-home use is supported by simple, reliable tools for self-assessing gestational age, alongside straightforward instructions. There are ample data showing that at-home self-administration has the same safety profile as clinic-based administration under medical supervision.

In light of this, achieving the Biden administration’s goal for accessible medication abortion requires allowing misoprostol to be both prescribed and dispensed at any pharmacy. These measures would make medication abortion more available and accessible in several ways.

First, it would mitigate the effects of state-level abortion bans and restrictive laws. A pregnant person living in, for example, Indiana—the first state to definitively ban abortion after the Dobbs decision—who was seeking a medication abortion would be able to travel to Illinois, where abortion is available upon request, and purchase a safe, effective abortifacient at a pharmacy without the need to face the delays, costs, and other challenges of navigating our unnecessarily overmedicalized health care system.

Second, pharmacy-based prescription would reduce the burdens associated with seeking abortion care even in states with the strongest abortion protections. Pharmacies are the first point of care for many Americans, and visits to pharmacies far outnumber visits to primary care providers, especially in underserved and rural areas. Pharmacist-prescribed medication abortions would result in less travel, reduced costs, and reduced time off work or away from family.

Finally, allowing pharmacies to dispense misoprostol for home use is a smaller change than it seems. It would be consistent both with standard medical practice in dozens of countries and with how the drug is currently administered as part of the mifepristone plus misoprostol combined regimen. In less-restrictive states, patients already self-administer the drugs at home. Pharmacy prescriptions for misoprostol would work in the way that prescriptions currently do for many other medications, including birth control, naloxone, and medications for HIV prevention, smoking cessation, and travel.

Pharmacists would need to receive training on indications for treatment, side effects and risks, how to instruct patients, and the legality and acceptability of pharmacy-dispensed abortifacients. Information would need to be freely available from government sources (alongside existing instructions from organizations such as Planned Parenthood and local advocacy groups), including public health campaigns in multiple languages and with pictorial instructions. These processes are all relatively commonplace and easy to implement.

Adapting To A Post-Roe America

Policy makers and advocates need to look ahead to years or decades of restrictions on reproductive health care without federal protection of abortion rights. Despite these circumstances, our health care policy around abortion needs to find ways to ensure the broadest possible access and expanding choices to care without relying on the possibility of an eventual federal protection.

To that end, moving forward with a misoprostol-only regimen for medication abortion would have tremendous impact on access to care, especially for pregnant people forced to cross state borders to receive treatment. The effort will require private-sector commitment and ambition, input from advocates and activists, and expert advice from medical professional bodies, all brought together by the Biden administration’s determination to live up to their goals. If our nation is truly committed to protecting abortion access in the US, it should pursue adoption of the misoprostol-only regimen.