New research finds that abortions prescribed over the phone or online can be safe and effective. The study found that a large majority of women who received medication abortions in California last year via telehealth service required no follow-up medical care, and no major adverse events were reported. The findings may be especially relevant given a pending decision by the U.S. Food and Drug Administration on whether it will permanently lift a requirement for abortion drugs to be distributed in a doctor’s office.
Medication abortion is usually carried out with a two-drug combination of mifepristone and misoprostol, taken within the first 10 weeks of pregnancy. Mifepristone has been under a Risk Evaluation and Mitigation Strategy (REMS), a restriction imposed by the FDA on how a drug can be used.
This restriction mandates that patients receive mifepristone dispensed through a hospital, clinic, or medical office, effectively meaning that it has to be provided in-person (often, patients are also told to receive in-person counselling and/or an ultrasound exam). Though the stated justification for this restriction was the worry that these drugs could regularly cause serious health complications like major haemorrhaging, subsequent research in the U.S. and elsewhere hasn’t borne out this concern.
For years, women’s health advocates and scientists have been calling for the REMS on mifepristone to be lifted, along with other unneeded burdens on abortion care. And when the covid-19 pandemic hit, leading to many restrictions on in-person services, the American College of Obstetricians and Gynecologists and others sued the FDA in federal court to get the program temporarily suspended.
Soon after, in July, the court issued an injunction that lifted the ban for the duration of the pandemic being a public health emergency. The FDA, then under the Trump administration, fought the injunction, appealing it to the Supreme Court. By January this year, the Court granted the FDA’s wish and reversed the ruling. However, the newly installed Biden administration then reversed course, and, in April 2021, the FDA issued guidance lifting the REMS restriction temporarily.
Between all this back-and-forth, various telehealth services were able to dispense abortion drugs remotely throughout the latter half of 2021. This new study, published Tuesday in JAMA Network Open, focuses on the outcomes of patients in California who received abortion care through a virtual clinic called Choix.
All told, the researchers looked through the de-identified records of 141 patients between October 2020 and January 2021. Of these, 81% had data on their outcomes. And of these, 95% reported having a complete abortion without the need for any further medical intervention. Five patients (5%) sought out extra care, two at an emergency department. But no major adverse events were reported by any patients.
“This research demonstrates that medication abortion provided by telehealth and dispensed to patients by mail-order pharmacy is safe and effective,” said study lead author Ushma Upadhyay, an associate professor at San Francisco’s Bixby Centre for Global Reproductive Health. “FDA policy should be based on the latest medical evidence. It’s time that the FDA permanently removes the in-person dispensing regulations on mifepristone.”
The findings are based on a small sample size and limited to a single clinic’s patients, so they should be validated further. But the researchers note that a 95% initial success rate is similar to what’s seen when the drug is doled out in-person, as well as rates seen at telehealth programs in other countries. And they should definitely provide some important data to guide the FDA decision on whether to fully lift the REMS ban on mifepristone.
Even if the FDA does remove the in-office prescribing requirement, it would likely require further legal action to overturn state bans on telehealth abortions, which may not ultimately succeed, given the conservative leaning of the Supreme Court and their earlier decision this year. There remain many impediments to reliable and timely abortion care, in some states more than others. But the lifting of the REMS would nonetheless represent a genuine step forward for women’s health in the U.S.