On Jan. 12, 2021 in a 6-3 ruling, the Supreme Court reinstated the FDA’s in-person mandate for the abortion medication, mifepristone. Earlier in July 2020, a federal court had lifted this requirement due to the COVID-19 pandemic.
Mifepristone and misoprostol are the two medications used in medical abortion. Misoprostol does not have the in-person requirement that mifepristone has. While the physician consult may be conducted virtually, the prescription for mifepristone must be picked up at a hospital, clinic, or medical office.
Chief Justice Roberts emphasized the purpose of the Supreme Court in the ruling. The Supreme Court was not determining if “the requirements for dispensing mifepristone impose an undue burden on a woman’s right to an abortion as a general matter.” Rather, they were deciding if the federal court in July “properly ordered the FDA to lift those established requirements because of the court’s own evaluation of the impact of the COVID-19 pandemic.” The conclusion being the Supreme Court “did not see a sufficient basis here for the District Court to compel the FDA to alter the regimen for medical abortion.”
Dissenters, Justice Sotomayor and Justice Kagan, argued, “the FDA policy imposes an unnecessary, unjustifiable, irrational, and undue burden on women seeking an abortion during the current pandemic.” They made a few arguments in support of this position.
First, the limited clinic options and reduced availability of medical offices make it more difficult for women to get an appointment. Second, three-fourths of abortion patients are low-income which means they require public transportation to go to and from the clinic. They said this places these women at increased risk of COVID-19 exposure. Third, they argue that the FDA permits opioids to be mail-ordered, yet still requires mifepristone to be picked up in person. Last, medication abortions are only permitted in the first ten weeks of pregnancy. Therefore, these restrictions can cause women to miss this window. After ten weeks, their only option is a surgical abortion which is more invasive and poses increased safety risks.
Interestingly, the reason the FDA instituted this in-person regulation on mifepristone is for safety reasons. In 2011 and 2016, a risk assessment was performed to ensure the safe use of the drug. Both years, the FDA concluded, “certain restrictions continue to be necessary to ensure the safe use of mifepristone.” This is for good reason. From 2012 to 2018, the data shows that 1455 women had an adverse event after taking mifepristone. 274 women were hospitalized, 183 required blood transfusions, and 104 had infections following medication usage. The FDA has these safeguards in place to ensure women taking mifepristone remain safe and have access to emergency care if needed.
The outgoing Trump administration pushed for this reinstatement as their final effort in favor of the pro-life movement. The good news is that this ruling renews a barrier for women who seek a medication abortion. This is only temporary good news, however. Justices Sotomayor and Kagan might just get what they want in due time. The new Biden administration will likely remove this in-person requirement and will re-evaluate the FDA’s restriction on mifepristone. Biden’s pick for Secretary of Health and Human Services, California Attorney General Xavier Becerra, has a 100% voting record in favor of abortion policies. Therefore, removing this FDA mandated in-person restriction on mifepristone seems entirely probable.