FDA Appeals to Supreme Court Over Abortion Pill Regulations

The normal requirement of the Food and Drug Administration (FDA), in place since 2000, is that the abortion pill be dispensed and administered in-person.

Abortion pills, RU-486 spill out over an ultrasound image.
Abortion pills, RU-486 spill out over an ultrasound image. (photo: Ivanko80/Shutterstock / Ivanko80/Shutterstock)

WASHINGTON — The Trump administration is again appealing to the Supreme Court to preserve its abortion pill regulations—arguing that in 2020 abortions have increased in states where the regulations remained.

On Monday, the administration filed a supplemental brief at the Supreme Court, asking the court to uphold its abortion pill restrictions by reversing a federal judge’s injunction on the restrictions. 

The normal requirement of the Food and Drug Administration (FDA), in place since 2000, is that the abortion pill be dispensed and administered in-person. The regulation is part of the REMS protocol, reserved for higher-risk drugs and procedures. 

The American College of Obstetricians and Gynecologists and other pro-abortion groups pushed for the restrictions to be lifted during the pandemic so women would not have to travel to get the abortion pill; they successfully won an injunction on the restrictions in July, at a federal district court.

Judge Theodore D. Chuang of the District of Maryland lifted the FDA’s requirement during the coronavirus pandemic, ruling that women could be prescribed the pill remotely and have it delivered or mailed to them.

In response, members of Congress asked the FDA to classify the abortion pill regimen as a public health hazard, and remove it from the market. 

Justice Department attorneys appealed the case to the Supreme Court, which in October did not reverse Chuang’s decision or rule on the merits of the case; the court rather sent the case back to be reconsidered in several weeks, with the administration having an opportunity to present new evidence for its case.

Chuang did not change his ruling in a Dec. 9 decision, writing that the pandemic circumstances have not changed and women will still have difficulties traveling to obtain a prescription for the pill regimen in-person.

He wrote that “particularly in light of the substantial spread of COVID-19 in recent weeks that increases the risk of all travel, the Court does not find that any changes to economic conditions or access to medical facilities, childcare, or transportation since the issuance of the (prior block on the rule) have been so favorable as to constitute changed circumstances" to justify lifting the block.

The administration then appealed back to the Supreme Court, saying it presented new evidence to Chuang that its restrictions are not an unlawful “undue burden” on abortion, because of the increase in abortions in certain states.

In a brief submitted to the Supreme Court on Tuesday, the acting Solicitor General Jeffrey Wall argued that the U.S. Food and Drug Administration (FDA) regulations of the abortion pill be kept in place during the pandemic.

He pointed to “newly available evidence showing that in States where requirements of in-person visits have remained in effect as a matter of state law, the number of abortions provided during the pandemic has in fact increased as compared to the equivalent period in 2019.”