U.S. District Court Judge Rules to Revoke FDA Approval of Abortion Pill

UPDATE, 4/10/23: The Biden administration DOJ filed a notice of appeal to the Fifth Circuit the same day that Judge Kacsmaryk released his decision, and today officially filed its appeal, asking that the district court’s decision be kept on hold until the Fifth Circuit decides the case.

4/7/23: District Court Judge Matthew J. Kacsmaryk ruled today to overturn the Food and Drug Administration’s (FDA) approval of mifepristone, the abortion drug that was approved for use in the United States in 2000. The FDA is likely to appeal the decision. Kacsmaryk gave a week for the order to take effect, giving the Biden administration that time to file an appeal.

The ruling means that mifepristone, the first drug of the abortion pill regimen, no longer has FDA approval and could result in a new FDA review of mifepristone. In anticipation of this ruling, the abortion industry has been planning to move to a misoprostol-only abortion method that carries a high failure rate. However, some abortion businesses, including Whole Women’s Health, have announced they “will not immediately stop prescribing mifepristone” based on Kacsmaryk’s ruling.

Misoprostol is the second drug in the current abortion pill regimen. While the first drug, mifepristone, acts to block the naturally occurring hormone progesterone (depriving the child of nutrients needed to grow), misoprostol causes contractions that expel the baby from the uterus.

“The U.S. Food and Drug Administration chose politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000,” said 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, the Christian Medical & Dental Associations, and others in the lawsuit brought against the FDA in November.

“The only way the FDA was able to approve the drugs was by characterizing pregnancy as an ‘illness’ and arguing that these drugs provide a ‘meaningful therapeutic benefit.’ As the medical groups and doctors filing suit explain, by approving chemical abortion drugs, the FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women,” ADF added. “The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.”

In addition to approving the drugs on “shaky legal and moral ground,” as explained by ADF Senior Counsel Erik Baptist, the FDA has had “years of evading responsibility….”

In 2016, the FDA extended the gestational age of the baby that can legally be killed by the abortion pill from seven weeks’ gestation to 10 weeks gestation. This puts women at a greater risk of complications from the already dangerous abortion pill regimen as abortion grows riskier with each week of pregnancy. The FDA at that time also changed the dosage and administration method of the abortion pill, reduced the required in-person doctor’s visits for taking the abortion pill from three to one, and allowed non-physicians to prescribe and administer mifepristone. In addition, the FDA told abortionists they no longer had to report any non-fatal complications from the abortion pill to the manufacturer, thereby helping to hide the complications that did result from the reduced FDA

Then in 2021, the Biden FDA decided that the abortion drugs could be sent through the mail — a direct violation of federal law. In 2023, the FDA announced its decision to allow retail pharmacies to become distributors of the abortion pill regimen.

“Over twenty years ago, the FDA caved to pressure from the abortion lobby and neglected the health and safety of women and children to approve the distribution of mifepristone, whose intended use is to starve a living child,” said Live Action founder and president Lila Rose. “This deadly drug is approved for use up through ten weeks of pregnancy, at which point a human child has arms, eyelids, fingers, toes, and organs. These children have beating hearts, and if they were not intentionally killed, they would live. In combination with misoprostol, the abortion pill regimen accounts for over half of all abortions in the United States.”

She added, “Health care heals. It does not kill. The FDA’s decision to approve the chemical abortion pill was egregiously wrong from the outset and has been a grave wound in the soul of our country. This ruling is a huge step towards protecting women and their unborn children, but the battle does not end here.  We expect that this decision will be appealed by abortion advocates and may ultimately make its way to the Supreme Court.”