The status of mifepristone, an abortion medication, has been thrown into uncertainty following contradictory rulings by two federal judges. The drug is used in over half of all abortions in the US, and the opposing opinions will inevitably lead to a high court decision, possibly expedited by the contradictory rulings.
In Texas, U.S. District Judge Matthew J. Kacsmaryk suspended the FDA’s approval of the drug, while U.S. District Judge Thomas O. Rice in Washington ruled that the drug is safe and effective. The Texas ruling, which will not go into effect for seven days to allow for an appeal, marks the first time a judge has suspended FDA approval of a medication despite opposition from the agency and the drug’s manufacturer.
The Texas lawsuit, brought by the legal group Alliance Defending Freedom on behalf of pro-life medical organizations and four doctors, claimed that the FDA did not have the power to approve the drug and took issue with the agency’s easing of restrictions on the pill through the years.
In his ruling, Judge Kacsmaryk was highly critical of the FDA’s decisions to loosen restrictions on how the pill is administered and faulted the FDA for “lax reporting requirements”. Kacsmaryk further criticized the FDA for basing its decision on unsound reasoning and studies that did not support its conclusions. He also suggested that the FDA faced significant political pressure to increase access to chemical abortion.
Meanwhile, the Justice Department and drug manufacturer Danco Laboratories have filed their notice of appeal against the Texas ruling, and Attorney General Merrick Garland stated that the government would ask the U.S. Court of Appeals for the 5th Circuit to allow the FDA to maintain approval of the pill until the outcome of the case is determined. The department is still reviewing the decision out of Washington. It appears that the issue will eventually reach the Supreme Court due to the conflicting opinions.
Alliance Defending Freedom (ADF), the legal team representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and others in the lawsuit alleged that the FDA prioritized politics over science. They brought this against the FDA in November, when it advocated for legalizing the chemical abortion drugs mifepristone and misoprostol in 2000.
According to ADF, the FDA approved the drugs by categorizing pregnancy as an “illness” and arguing that they provide a “significant therapeutic benefit.” However, the medical groups and doctors who filed the lawsuit argue that by approving chemical abortion, the FDA failed to fulfill its legal obligation to safeguard the health, safety, and well-being of women and girls.
ADF also stated that the FDA never conducted safety studies of the drugs under the labeled conditions of use, disregarded the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, ignored substantial evidence that chemical abortion drugs lead to more complications than surgical abortions, and eliminated necessary protections for pregnant girls and women undergoing this dangerous drug regimen.
The ruling by Judge Kacsmaryk is a sign that judges are beginning to take a more critical look at the FDA’s decisions and are willing to intervene when the agency fails to live up to its statutory duty. The FDA must be held accountable for its decisions and forced to follow the necessary safety precautions.
Join Choices in the Fight for Life
While this ruling is a victory for the pro-life movement, there is still a lot of work to do – and Choices Pregnancy Centers is prepared for the battle ahead. A subsequent effect of this ruling is the inevitable increase in black market abortion pill transactions. Women will likely seek alternatives to end their pregnancies, regardless of the legality or approval from the Food and Drug Administration.
This is why centers like Choices must remain vigilant in not only educating young women about their choices, but also being available to offer them the true healthcare that they deserve. Please consider joining us in our vital ministry. Your support matters! You can get involved by praying for us, donating, or volunteering! Call Choices today for more information!