Court keeps mifepristone available during appeals process

WASHINGTON (BP)—The U.S. Supreme Court ruled April 21 mifepristone will remain on the market for the time being while its approval is legally challenged.

In a 7-2 decision, the high court granted stays to lower court opinions that suspended the U.S. Food and Drug Administration’s legalization of the abortion drug or restored previous restrictions on its use.

As a result, mifepristone—the first drug in a two-step process commonly referred to as medical or chemical abortion—will be available under the same guidelines in place before court decisions the last two weeks.

In early April, U.S. District Judge Matthew Kacsmaryk of Amarillo issued a preliminary ruling seeking to halt the prescribing of mifepristone, saying the FDA had “acquiesced on its legitimate safety concerns.”

The New Orleans-based Fifth Circuit Court of Appeals, which had restored earlier conditions on mifepristone’s use and distribution, is scheduled to hear oral arguments in the case May 17.

Response to court ruling

Abortion opponents had hoped the Supreme Court would at least permit the Fifth Circuit’s action to remain in effect during the appeals process.

“Though this case is far from over, today’s decision is deeply disappointing, as it will continue to allow preborn lives to be taken and women to be harmed by this dangerous chemical abortion drug,” said Hannah Daniel, policy manager for the Southern Baptist Ethics & Religious Liberty Commission.

“As this case moves toward a final outcome, we will continue to urge the courts and the FDA to take action that protects women and the preborn. While today’s ruling is certainly a setback, we remain hopeful and resolved as we fight for a culture of life.”

Erik Baptist, senior counsel for Alliance Defending Freedom, said it is “common practice” for the high court “to maintain the status quo” that existed before a legal challenge. “We look forward to a final outcome in this case that will hold the FDA accountable,” he said in a written statement.

ADF is representing pro-life doctors and associations in their challenge to the FDA’s approval of mifepristone.

The White House and abortion rights advocacy organizations welcomed the high court’s order.

President Biden said he would “continue to stand by FDA’s evidence-based approval” of the abortion pill.

“I will continue to fight politically-driven attacks on women’s health,” he said.

Rachel Laser, president and CEO of Americans United for Separation of Church and State, applauded the court’s decision.

“The court made the right decision to stay Judge Kacsmaryk’s unprecedented order, which ignored long-established science and medical guidance to advance the agenda of religious extremists seeking to ban all abortions and force all of us to live according to their narrow beliefs,” Laser said.

“Abortion bans violate the separation of church and state by enshrining one narrow religious viewpoint into our law. Kacsmaryk’s ideologically driven opinion was of a similar character.

“If America is to make good on its promise of religious freedom, each of us must be free to make our own decisions about our own bodies based on our own beliefs. That’s why we need a national recommitment to the separation of church and state. It’s the shield that protects freedom without favor and equality without exception for all of us.”

Mixed opinion about chemical abortion

Mifepristone, authorized by the FDA under President Clinton, causes the lining of the uterus to release the embryo, resulting in termination of the pregnancy. Misoprostol, a drug approved by the FDA to treat ulcers, is typically taken one to two days later and causes the uterus to contract, expelling the embryo.

Medical/chemical procedures constitute a majority of all abortions in the United States. Medical/chemical abortions increased between 2001 and 2020 from five percent of all such procedures to 53 percent, the Guttmacher Institute reported in December.

The case arrived at the Supreme Court on emergency applications from the FDA and Danco Laboratories, which manufactures mifepristone, following decisions by Kacsmaryk and the Fifth Circuit.

In his April 7 opinion, Kacsmaryk said the FDA failed in 2000 to address safety concerns in approving mifepristone. He delayed implementation of his suspension of the drug’s approval for seven days to permit the Biden administration time to pursue “emergency relief” from the Fifth Circuit.

A three-judge panel of the appeals court ruled April 12 the statute of limitations had expired regarding a challenge to the FDA’s approval of mifepristone, but it rejected an FDA request that it block Kacsmaryk’s prohibition on actions taken by the federal agency in 2016 and thereafter. Those FDA actions included increasing mifepristone’s use from seven weeks to 10 weeks of gestation, reducing the number of in-person visits with a doctor from three to one and allowing distribution of the drug by mail.

In an April 14 order, Associate Justice Samuel Alito, who is assigned motions that arise from the Fifth Circuit, placed a temporary hold on the earlier decisions until the Supreme Court as a whole acted.

Associate Justice Clarence Thomas joined Alito as the lone members to dissent from the court’s order.

In his dissent, Alito said the FDA and Danco “are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.” The stay issued by the Fifth Circuit would not eliminate mifepristone from distribution but only renew the conditions in place from 2000 to 2016, Alito said.

In January, the FDA announced retail pharmacies would be able to carry and dispense mifepristone for the first time.

The decision was among the actions taken by the Biden administration in an effort to minimize the effect of the Supreme Court’s reversal of the 1973 Roe v. Wade ruling. In June 2022, the high court returned abortion policy to the states by overturning Roe, which legalized abortion throughout the country.

About 32,000 fewer abortions were reported in the six months after the Supreme Court’s June opinion in contrast to the period before the decision, according to a study issued April 11 by the Society of Family Planning.

The FDA spent four years considering the application for mifepristone’s distribution in this country and says the drug is safe for women to use.

The Charlotte Lozier Institute, however, reported in 2021 a new study it conducted found “chemical abortion is consistently and progressively associated with more postabortion [emergency room] visit morbidity than surgical abortion.”

An analysis of Medicaid claims information from 17 states that pay for abortions showed the “rate of abortion related ER visits following a chemical abortion increased 507 percent” between 2002 and 2015, according to CLI, a pro-life, research organization.

Anti-abortion advocates have long opposed the legalization of mifepristone. 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.

In 2020, then-ERLC President Russell Moore and more than 20 other pro-life advocates 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 preborn children.

With additional reporting by Managing Editor Ken Camp.