The decision upholds the district court’s order that restores the earlier safeguards.
WASHINGTON, D.C.—On 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 Fifth Circuit has maintained the portion of U.S. District Judge Matthew Kacsmaryk’s order requiring the FDA to reinstate previous safeguards for chemical abortion drugs.
The United States Department of Justice has announced its intention to seek emergency relief from the Supreme Court.
The 5th Circuit decision revokes the 2016, 2021, and 2023 amendments to the FDA’s relaxation of the initial safeguards it had implemented for mifepristone. It also reinstates the original stipulations that the drug be utilized exclusively up to seven weeks of pregnancy, including three physician visits. Furthermore, it eliminates the possibility of the drug being shipped or dispensed by pharmacies, prohibits non-physicians from administering the drug, and reinstates the obligation to report non-fatal adverse events.
The case was initiated by the Alliance for Hippocratic Medicine against the U.S. Food and Drug Administration (FDA) in relation to the abortion drug mifepristone.
“This drug does not treat or cure a disease but results in the death of an unborn child and endangers the life of the child’s mother through the administration of dangerous and life-threatening side effects,” stated Carol Tobias, president of National Right to Life. The 5th Circuit Court of Appeals has acknowledged that the FDA’s removal of regulatory safeguards for this dangerous drug increases the risk of life-threatening harm to women.
In the lawsuit Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), the plaintiffs contended that the FDA had unlawfully expedited 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 for a week to allow the Department of Justice to appeal.
In their decision, the Fifth Circuit observed that:
- It is important to note that women who take these drugs are susceptible to torrential bleeding. Indeed, the risk of severe bleeding associated with chemical abortion is approximately five times higher than that associated with surgical abortion. Furthermore, these circumstances can rapidly deteriorate. (p. 14)
- Following the removal of the adverse-event reporting requirement, the FDA reversed its stance in 2021, declaring the absence of non-fatal adverse-event reports to indicate the safety of mifepristone. It is unreasonable for an agency to eliminate a reporting requirement for a substance and then use the resulting absence of data to support its decision. (p. 35)
As observed by Judge Kacsmaryk in his ruling on Friday, 7 April,
The Court is reluctant to second-guess the FDA’s decision-making process. However, in this instance, the FDA conceded to its legitimate concerns regarding safety, in contravention of its statutory obligations. This was based on reasoning that was manifestly unsound and studies that did not substantiate its conclusions. Furthermore, there is evidence indicating that the FDA was subjected to significant political pressure to forego its proposed safety precautions in order to better advance the political objective of increased “access” to chemical abortion, which was the “whole idea of mifepristone”. (p. 57)
The Guttmacher Institute, an organisation affiliated with the abortion industry, has estimated that approximately 54% of all abortions are performed using the chemical abortion method, which involves the administration of mifepristone and misoprostol.
For over two decades, the abortion industry has disseminated misinformation about the simplicity of chemical abortions, while simultaneously advocating for the reduction of protections for women. The 5th Circuit Court of Appeals recognized in its decision that the drug is dangerous and that the proposed loosening of protections for women is unreasonable.
Mifepristone is employed in conjunction with misoprostol, a prostaglandin, to induce an abortion. Mifepristone inhibits the action of progesterone, resulting in the demise of the unborn child. The second pharmaceutical agent, misoprostol, induces powerful and painful uterine contractions, facilitating the expulsion of the dead or dying infant.
The FDA has recently relaxed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug, thus enabling it to be dispensed and even mailed by pharmacies. The stay prevents the FDA from implementing the most recent changes to the drug’s administration. The court described these as follows:
(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 abortion 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’. This was stated by 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 experiencing haemorrhaging, dealing with infections, or ectopic pregnancy, represents thousands of women in urgent need of treatment, which may or may not be available locally.”
On 5 April, the National Right to Life organisation published a paper in which it sought to debunk several myths surrounding the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).
A comprehensive analysis of the numerous myths perpetuated by the media regarding the FDA’s approval and management of Mifeprex (mifepristone) can be accessed here.
Daniel Miller is responsible for nearly all of National Right to Life News' political writing.
With the election of Donald Trump to the U.S. presidency, Daniel Miller developed a deep obsession with U.S. politics that has never let go of the political scientist. Whether it's the election of Joe Biden, the midterm elections in Congress, the abortion rights debate in the Supreme Court or the mudslinging in the primaries - Daniel Miller is happy to stay up late for you.
Daniel was born and raised in New York. After living in China, working for a news agency and another stint at a major news network, he now lives in Arizona with his two daughters.
