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Court restores FDA restrictions on abortion pill


WASHINGTON (BP) – The U.S. Supreme Court restored Tuesday afternoon (Jan. 12) a federal rule that requires a woman to go to a health care facility to obtain the abortion drug mifepristone.

The high court’s order came barely three months after it had declined to put on hold a federal judge’s nationwide injunction that blocked the U.S. Food and Drug Administration (FDA) from enforcing its requirement during the COVID-19 pandemic. In issuing his injunction in July, Theodore Chuang of Maryland ruled the FDA’s in-person requirement violated the right to abortion during the pandemic. His decision enabled women to receive the abortion pill by mail or another form of delivery.

In an Oct. 8 decision, the Supreme Court returned the case to Chuang for his consideration of the FDA’s request to revise or end the injunction. At the time, the high court had only eight justices. Amy Coney Barrett – a conservative appeals court judge whom President Trump had nominated to replace the late Associate Justice Ruth Bader Ginsburg – had yet to be confirmed to the court, an action the U.S. Senate took Oct. 26.

Chuang rejected the FDA’s request Dec. 9, saying an in-person visit would still place women at risk during the pandemic. The federal agency returned to the Supreme Court Dec. 15 to ask the justices to block the injunction and thereby reinstate its requirement of an in-person visit to receive the drug.

Mifepristone – often known as RU 486 and authorized by the FDA under President Clinton in 2000 – is part of a two-step process in what is referred to as a medical or chemical abortion. Mifepristone, sold under the brand name Mifeprex, causes the lining of the uterus to release the embryonic child, resulting in his or her death. Misoprostol, a second drug taken later, causes the uterus to contract, expelling the body.

Pro-life advocates have long opposed the legalization of mifepristone not only because of its lethal effect on unborn children but its risk to women who are not under a doctor’s direct care when they take the pill. Pro-life leaders commended the Supreme Court’s decision.

Southern Baptist public policy specialist Chelsea Sobolik said mifepristone “is highly dangerous for women and ends the life of an unborn baby. Requiring basic health and safety guidelines to be followed for the use of such a drug is just common sense.”

“While abortion advocates will object, this decision from the Supreme Court reinstates FDA requirements that will protect women’s health and potentially save the lives of countless children,” said Sobolik, a policy director for the Ethics & Religious Liberty Commission (ERLC).

The National Right to Life Committee (NRLC) is pleased the court “recognizes the serious nature of chemical abortions and the need for the FDA to have protocols in place to protect women from potentially life-threatening and devastating side effects,” NRLC President Carol Tobias said. “Chemical abortions put at risk healthy women who are pregnant with healthy babies.”

A leading abortion-rights defender – Alexis McGill Johnson, president of Planned Parenthood Federation of America – criticized the high court’s order as “a threat to public safety and an egregious step backwards for health equity.”

Johnson called on President Biden, who will take office Jan. 20, to overturn the FDA rule.

While the high court majority basically limited its comments to an announcement of its stay of Chuang’s decision, Chief Justice John Roberts said in a concurring opinion the primary question was not whether the FDA rule imposes “an undue burden” on the right to abortion. Instead, Roberts said he believes courts “owe significant deference” to the FDA and other entities responsible for public health.

Three justices who make up what is considered the Supreme Court’s liberal wing – Stephen Breyer, Sonia Sotomayor and Elena Kagan – dissented from the Jan. 12 decision to reinstate the FDA’s in-person requirement. In a dissent joined by Kagan, Sotomayor said the FDA rule “imposes an unnecessary, unjustifiable, irrational and undue burden on women seeking an abortion during the current pandemic” and the government has not shown the injunction has caused “irreparable harm.”

In response to the high court’s Oct. 8 order, Associate Justices Samuel Alito and Clarence Thomas disagreed, contending in a dissent written by Alito that there “is no legally sound reason for this unusual disposition.”

In his dissent, Alito said Chuang “took a strikingly different approach” than the Supreme Court on government restrictions during the pandemic. The high court has allowed state and local officials to dramatically limit freedom of speech and religion, he wrote.

“While COVID–19 has provided the ground for restrictions on First Amendment rights, [Chuang] saw the pandemic as a ground for expanding the abortion right recognized” in the 1973 Roe v. Wade decision, Alito wrote.

In late July, ERLC President Russell Moore and more than 20 other pro-life leaders called for the FDA to categorize mifepristone as an “imminent hazard to the public health” and to withdraw it from the market because of its threat to women as well as unborn children.

Mifepristone is “highly dangerous for women,” the letter said. The pill “poses a four-times higher risk of complication” than first-trimester, surgical abortion, the pro-lifers said, citing information from the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG).

The ERLC and other pro-life organizations worked to prevent the introduction of the abortion pill into the United States for more than a decade before the FDA gave its approval.

The case is FDA v. American College of Obstetricians and Gynecologists.