On Wed., Dec. 13, 2023, the U.S. Supreme Court agreed to review a case out of the 5th Circuit Court of Appeals. In that case, Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, the plaintiffs challenged FDA regulations in 2016 and 2021 which weakened the requirements under which the chemical abortion drug, mifepristone, could be administered. The 5th Circuit enjoined the dispensing of mifepristone due to FDA’s lack of evidence showing continued safety for women with these changes. Danco, the pharmaceutical company producing the drug, requested the review.
That case was consolidated with a similar case, Food and Drug Administration v. Alliance for Hippocratic Medicine, addressing the same issues.
Chemical abortions are on the rise in the United States. In the latest publicized statistics, they account for close to 60% of all abortions nationwide. In North Carolina, among residents of the state, 66% of abortions are chemical abortions. The abortion rate is up 6.8% and chemical abortions are up 21.1%.
There are two ways to perform an abortion — surgically and chemically. A surgical abortion requires the removal of the unborn child from the uterus. A chemical abortion requires the woman to consume two pills, one to kill the unborn child and one to cause the woman to expel the dead fetus.
Chemical abortion drugs were first created in France in 1988. Initially, the FDA banned them from the U.S. but in 2000, the FDA labeled abortion as a “serious, life-threatening illness” and approved the drugs with safeguards under an accelerated approval process. Under the safeguards, abortions could only be used to terminate a pregnancy through the seventh week; the drug had to be dispensed in the doctor’s presence and the doctor had to meet certain certification requirements.
Over the years, the restrictions have fallen by the wayside. In 2016, the gestational age was extended from 7 weeks to 10 weeks; in 2021, FDA proposed that the drug did not need to be given in person by the physician and in 2023, that in-person requirement was removed permanently.
Even if the plaintiffs are successful, the lawsuit will not permanently ban chemical abortions but could have the effect of severely reducing them unless and until the FDA can show that the safety of women is preserved with these changes. Returning the gestational age limit to seven weeks rather than ten and restoring the in-person requirement for dispensing by a physician, could eliminate the ease with which these abortions occur, saving the lives of unborn babies.
Mary Summa is General Counsel at NC Values.
