The Food and Drug Administration has now permanently lifted a restriction on abortion medication. On Thursday, the agency made official that it would no longer require the drug mifepristone — one half of a combination abortion regimen — to be dispensed in-person, following years of pressure from public health and reproductive rights groups. The decision will ensure that these pills can be prescribed virtually and mailed to patients throughout much of the country, but existing laws will still limit their availability in many states.
Mifepristone was first approved by the FDA in 2000. It’s taken in combination with misoprostol for abortions within the first 10 weeks of pregnancy. The treatment has proven to be safe and effective. But for decades, 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 has mandated that mifepristone must be dispensed to patients in-person, though they can then take it at home.
Given the treatment’s safety profile and the need for greater abortion access, groups like the American College of Obstetricians and Gynecologists (ACOG) have long called for the REMS on mifepristone to be lifted. And when the covid-19 pandemic struck in late 2019, leading to many restrictions on in-person interaction, the ACOG and others sued the government and won an injunction in court to have the ban temporarily lifted for the duration of the pandemic. The Trump administration won an appeal to have the injunction removed in January 2021, but the incoming Biden administration chose to keep the ban lifted.
Since then, advocates have been waiting for the FDA to issue a final decision the matter. Along the way, research has reaffirmed that abortion pills prescribed virtually are just as safe for patients as they are when prescribed in a doctor’s office. The FDA finally issued its verdict Thursday, and, as many had hoped, the REMS ban will stay permanently gone.
This will no doubt expand the ability for doctors and reproductive rights groups to provide medication abortion to those in need. When the ban was first lifted last year, for instance, several new telehealth sites opened up to prescribe mifepristone. But this expanded access will not be universal. According to the Kaiser Family Foundation, 19 states already have laws on the books that restrict the use of telemedicine for abortions, and more may follow.
As noted by our colleagues at Jezebel, there are ways that people in these states can still obtain these pills, such as by ordering them from the European organisation Aid Access before they’re pregnant. But these measures, valuable as they are, will likely only help a minority of people who need abortion in these hostile areas. An approaching Supreme Court decision on a case next year that many experts fear will overturn Roe v. Wade could further erode abortion rights dramatically on a local level.
While the FDA’s decision is certainly a important one, it is not enough to ensure widespread abortion access.