Decision Upholds District Court’s Order that Restores Earlier Safeguards

WASHINGTON, D.C.— Late Wednesday, a three-judge panel of the United States Court of Appeals for the Fifth Circuit granted a partial stay, pending appeal, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA). The 5th Circuit keeps in place the portion of U.S. District Judge Matthew Kacsmaryk’s order requiring the FDA to restore previous safeguards for chemical abortion drugs.

The Justice Department has announced they will be seeking emergency relief from the Supreme Court.

The 5th Circuit decision removes the 2016, 2021, and 2023 changes to the FDAs loosening of the original safeguards it applied to mifepristone and leaves in place the original requirements that it be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.

The case was brought by the Alliance for Hippocratic Medicine against the U.S. Food and Drug Administration (FDA) regarding the abortion drug mifepristone.

“This drug does not treat or cure a disease but kills an unborn child and exposes his or her mother to dangerous, life-threatening side effects,” said Carol Tobias, president of National Right to Life. “The 5th Circuit Court recognized that, by removing the guardrails on this dangerous drug, the FDA places women at greater risk of life-threatening harm.”

In the lawsuit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), the plaintiffs argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses. Judge Kacsmaryk issued a national injunction on the use of mifepristone in chemical abortions but stayed his ruling by a week to allow the Department of Justice to appeal.

In their decision, the Fifth Circuit noted:

• Women who take these drugs are susceptible to torrential bleeding. In fact, the risk of severe bleeding with chemical abortion is five times higher than from surgical abortion. And these situations can quickly go from bad to worse. (p. 14)
• After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is safe… It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision. (p. 35)

And as noted by Judge Kacsmaryk in his ruling on Friday, April 7:

The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion — which was the “whole idea of mifepristone.” (p. 57)

According to the Guttmacher Institute, the research organization affiliated with the abortion industry, approximately 54% of all abortions are done using the chemical abortion method involving mifepristone and misoprostol.

“For over 20 years, the abortion industry has peddled lies about the ease of chemical abortions all while pushing for lowering the protections for women,” said Tobias. “In its decision, the 5th Circuit Court recognized that the drug is dangerous and loosening protections for women is unreasonable.”

Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.

The FDA recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies. Under the stay, the FDA cannot allow the most recent changes it made in the administration of the drug. The court described these as:

(1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion (p.5)

“The court notes that the FDA eliminated the reporting of non-fatal adverse events associated with mifepristone and then used the absence of reports as a basis for declaring that mifepristone was ‘safe,’” said Dr. Randall K. O’Bannon, Ph.D., director of Education and Research for National Right to Life. “When hundreds of thousands of women take these pills, even a couple of percentage points of women hemorrhaging, dealing with infections, or ectopic pregnancy, represents thousands of women desperately seeking treatment, which may or may not be nearby.”

On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.

Founded in 1968, the National Right to Life Committee (NRLC), the federation of affiliates in each of the 50 states and the District of Columbia and more than 3,000 local chapters, is the nation’s oldest and largest grassroots pro-life organization. Recognized as the flagship of the pro-life movement, National Right to Life works through legislation and education to protect innocent human life from abortion, infanticide, assisted suicide and euthanasia.