WASHINGTON, D.C.— On Tuesday, September 12, National Right to Life released a white paper challenging the media coverage of the decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA) issued by the U.S. Fifth Circuit Court of Appeals in August.
In its decision, the Fifth Circuit determined that when the FDA loosened regulations in 2016 and 2021 regarding the drug mifepristone, it did so unlawfully, failing to give adequate consideration to demonstrated safety issues with the drug. The decision will not impact the distribution of the abortion drug Mifeprex (generic: mifepristone) until the U.S. Supreme Court weighs in.
“While most reporters accurately reported the recent decision by the U.S. Fifth Circuit Court of Appeals, they generally failed to report the legal reasoning and medical evidence backing this decision, making it appear to be simply one more volley in a long-running political controversy,” stated Randall K. O’Bannon, Ph.D. director of education and research for National Right to Life and author of the white paper. “Anyone taking the time to read the decision can see that the court had ample reason to rein in the FDA.”
O’Bannon continued, “It is clear from the decision that the FDA put abortion politics over medical science and the interests of women.”
In his analysis of the court decision, Dr. O’Bannon reviews the original protocols put in place when mifepristone was first approved by the Food and Drug Administration. However, the FDA, bowing to pressure from pro-abortion groups, loosened the rules governing the use and distribution of the drug. Dr. O’Bannon notes that the Fifth Circuit:
- Found that there was harm to both patients and the doctors who had to treat them.
- Used the FDA’s own data against it.
- Made it clear that the courts, by law, have the duty to question FDA decisions when the agency fails to follow its procedures and ignores evidence of safety issues.
- Found that the FDA violated its statutory obligations.
- Found that the FDA failed to collect data on the collective impact of all the protocol changes it proposed in 2016.
- Criticized the FDA for using a lack of data—that the agency itself failed to collect—to justify dropping safeguards.
“Most reporters failed to read the decision and reported only the result,” stated O’Bannon. “But the court’s decision was firmly grounded in the FDA’s actions and the agency’s failure to abide by its own rules and regulations.”
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.
FDA records include more than two dozen deaths and thousands of complications associated with the use of the mifepristone/misoprostol chemical abortion method. Thousands of “adverse events” are on record with the FDA and include serious infections, severe hemorrhaging, and the rupture of previously undiscovered ectopic pregnancies.
What the Media Missed in Its Coverage of the U.S. Fifth Circuit Court of Appeals Decision Regarding Mifepristone can be accessed here.