On Thursday, the Food and Drug Administration (FDA) permanently loosened several strictions on abortion pills, including allowing patients to permanently receive abortion pills by mail, as well as loosening the requirement that the medication be picked up in person.
Under the change, the new rule means millions of American women will be able to get a prescription via an online consultation, broadening access as well as eliminating the limited dispensing to a small number of specialty clinics and doctor’s offices. It could also help some women circumvent restrictions on abortion in states like Texas, where patients must pick up the medication in person and can’t acquire it through a telehealth appointment.
The expansion of telehealth services during the pandemic spurred greater access to the regimen, which was approved by the FDA in 2016 to terminate pregnancies up to 70 days gestation.
Thursday’s move comes as the Supreme Court scrutinizes abortion access, and as several GOP-led states have taken steps to ban access to abortion medication through telehealth services.
But prescribing will still be limited to doctors who complete special certification. Additionally, the agency said dispensing pharmacies will have to be registered with the FDA.
The decision is the latest shift in the polarized legal battle over medication abortion, which has only intensified amid the disruptions of the COVID-19 pandemic. It is certain to spur legal challenges and more restrictions in GOP states.
The FDA’s latest scientific review stems from a 2017 lawsuit by the American Civil Liberties Union (ACLU), which argued that the agency’s restrictions block or delay medical care, especially for low-income and rural communities.
The ACLU hailed the elimination of the strictest requirements but said regulators should have gone further and allowed prescribing by any physician and broader dispensing.
The Biden administration in May said it would review requirements for mifepristone. The previous year, a group of doctors and advocates, led by the American College of Obstetricians and Gynecologists, challenged the previous FDA restrictions on receiving abortion pills by mail.
The FDA temporarily lifted the restrictions on mifepristone in July 2020, in response to a court order that was later reversed by the Supreme Court. The restrictions on mifepristone were again rolled back on a temporary basis by the FDA in April of this year.
The FDA has said the regimen is largely safe, and that it’s the most common method for ending a pregnancy in the first 10 weeks. The likelihood of complications is less than 1% according to the American College of Obstetricians and Gynecologists.
Nearly 4 million patients have taken the drug regimen since 2000, with only about 24 associated deaths as of 2018, the FDA said. The agency cautioned, however, that those deaths, could not be causally linked to the drug with certainty because of the patients’ use of other drugs, receipt of medical or surgical treatments, or their co-existing medical conditions and information gaps about their health status.