The 5th Circuit Court of Appeal upheld several parts of Federal District Court Judge Matthew J Kacsmaryk’s recent decision on the use of Mifepristone. Among them was the requirement that the drug be dispensed in person, not via mail-order, and not at retail pharmacies, and that the use of the drug be brought back to under 7 weeks gestation instead of under 10 weeks.
The 5th Circuit Court ruled that while the abortion pill can remain available, all adverse events relating to Mifepristone be once again reported — not just the deaths of women from the pill.
The case has brought to light the fact that the FDA eliminated the adverse-event reporting requirement, but then turned around in 2021 and declared the absence of non-fatal adverse-event reports meant that Mifepristone was safe! As one of the Appeals Court judges wrote, “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)
On Friday, April 14, the Supreme Court temporarily paused these restrictions, in response to the Biden Administration’s emergency application for a stay on the 5th Court of Appeals’ decision. The stay has been extended to Friday, April 21st. (See update below.)
Despite the temporary stay, the Federal District court and the Appeals Court have exposed the U.S. Food and Drug Administration’s illegal action in approving a drug that was never properly studied and assessed for its adverse and possible life-threatening effects on the health and safety of girls and women.
The FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, something that the Appeals Court judges could not ignore.
“The FDA has failed in its first duty to ensure the safety of American women and girls. All drugs must undergo strenuous testing, and must improve the welfare of people’s lives,” said Dr. William Pincus, NCRTL President. “Chemical abortion drugs do not provide a therapeutic benefit. Mifepristone endangers a healthy pregnancy, and has a 20% adverse event rate for the mother, in addition to ending a baby’s life.”1
Interestingly, according to LifeNews, the appeals court did not evaluate all of the safety arguments in the case, but it said that the FDA “cannot deny that serious complications from mifepristone” occur. The court even noted that the FDA had incorrectly compared mifepristone to ibuprofen. “FDA’s own documents show that mifepristone bears no resemblance to ibuprofen.”
We wait for the Supreme Court to weigh in.
UPDATE: As of Friday, April 21st, the U.S. Supreme Court has stayed lower court rulings and returned the issue to the 5th Circuit for a full hearing in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), which will take place on May 17, 2023. Chemical abortion drugs will stay on the market, for now.
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