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Court Order Keeps Abortion Drug Available with Restrictions

A box of medication used to induce abortion, known generically as mifepristone and by its brand name Mifeprex, is seen in an undated handout photo. A federal judge in Texas ruled April 7 to suspend the U.S. Food and Drug Administration’s approval of the medication abortion pill. (Photo: OSV News)

WASHINGTON — A federal appeals court in a 2-1 ruling just before midnight April 12 stopped part of the recent order by a Texas judge to suspend approval of the abortion pill mifepristone but the new ruling also put restrictions on the drug’s use.

 The appeals court ruling allows the U.S. Food and Drug Administration’s approval of the mifepristone to stand, but said the drug could not be obtained by mail without a visit to a doctor’s office and it also narrowed the window in which the pill could be obtained to only the first seven weeks of pregnancy, not 10 as it had been available previously.

 The decision by the panel of the 5th U.S. Court of Appeals was just days after the Justice Department swiftly appealed the April 7 ruling by U.S. District Judge Matthew Kacsmaryk, a nominee of former President Donald Trump. 

Kacsmaryk had suspended the FDA approval of the drug, saying that the agency incorrectly determined the drug’s safety and effectiveness and went beyond its regulatory authority when it approved it in 2000.

In response Thursday, the Justice Department said it will ask the U.S. Supreme Court for an emergency order to put any action on hold.

“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre said Thursday, speaking to reporters from Dublin during a visit by President Joe Biden.

The same day as the original Texas ruling, U.S. District Judge Thomas Rice in Washington, a former President Barack Obama nominee, said the FDA should not change the availability of mifepristone in the states involved in a lawsuit over the drug’s access.

The two very different rulings on mifepristone issued just an hour apart by federal judges highlight the country’s disparate views on the subject and signal that the Supreme Court will likely have to weigh in on the drugs’ future availability. 

The conflicting rulings centered on the FDA’s approval of mifepristone, one of two drugs used in more than half of the abortions in this country.

Kacsmaryk issued a nationwide injunction blocking FDA approval of the drug. His injunction would have gone into effect in seven days and gave the Justice Department time to appeal the ruling.

Rice did not grant a nationwide preliminary injunction to protect the drug’s availability, saying his order only applied to the 17 states and the District of Columbia that had filed a lawsuit seeking increased access to the drug.

The Department of Justice filed a request in a federal appeals court April 10 seeking to block the ruling by the Texas judge. It asked the court to put Kacsmaryk’s ruling on hold while the case worked through the appeals process.

Danco Laboratories, the New York company that distributes Mifeprex, the brand version of mifepristone, filed a similar request April 10.

The Justice Department has not yet said whether it will file an appeal in the Washington case.

The Washington case, led by the state’s Attorney General, Bob Ferguson, challenged restrictions the FDA has placed on the prescribing and dispensing of mifepristone.

The Texas case was filed by the group Alliance for Hippocratic Medicine on behalf of itself and member groups such as the Catholic Medical Association, the Christian Medical and Dental Associations, and other pro-life groups. The plaintiffs were represented by Alliance Defending Freedom, a religious liberty law firm.

The Texas hearing in mid-March examined the suit’s claims that the FDA “ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls” and disregarded evidence that chemical abortions cause more complications than surgical abortions.

The suit also claimed the FDA unlawfully fast-tracked mifepristone’s approval.

Mifepristone, also known as RU-486, is the first of a two-drug regimen used to end a pregnancy in its early stages — through 10 weeks gestation. It is often described as a medication abortion pill.

United States Conference of Catholic Bishops leaders have been vocal in their opposition to this drug since it was first given FDA approval in 2000. They echoed objections in 2016 when the FDA relaxed rules for its use, saying it could be administered with fewer visits to a doctor, and they also objected earlier this year when the FDA announced it was allowing some retail pharmacies to distribute the drug.

Pro-life leaders applauded the ruling by the Texas judge. “This decision shines a light on something that the Biden administration wants to sweep under the rug — that these drugs do not treat or cure disease but kill unborn children and expose their mothers to dangerous side effects. The FDA should be in the business of ensuring safety, not in taking lives,” said Carol Tobias, president of National Right to Life.

Similarly, March for Life President Jeanne Mancini told The Associated Press that the court’s decision “is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs.”

Dennis Poust, executive director of the New York State Catholic Conference, said in a statement that the goal of mifepristone is “to end a developing human life in the womb, which is always a tragedy. However, the question before the courts involves the drug’s safety for women and whether the FDA’s approval process in that regard was flawed.”

Poust added: “While we can’t predict what the courts will ultimately rule, the reality is for the pro-life movement to be truly successful in building a culture of life, it will be less about litigation and legislation and more about converting hearts and minds, and giving women in crisis pregnancies the supports they need to encourage them to carry their babies to term.”

The issue will likely come before the Supreme Court and sooner than later in an appeal to its emergency docket. This would be the first abortion case to come to the court since its ruling last year in Dobbs v. Jackson.

One thought on “Court Order Keeps Abortion Drug Available with Restrictions

  1. When will Catholics hear from the pulpit and a publication like this decry our so-called Catholic politicians and the DOJ and FBI targeting us? I am forever wondering about the silence, as are many of my family and friends.
    It, the silence, is a major concern.