FDA Put Abortion Politics Above Women’s Safety

No, the abortion pill is not safer than Tylenol or other headache medication, as pro-abortion activists claim. Now, a federal appeals court agrees, effectively reinstating safety precautions the Food and Drug Administration (FDA) had dropped in a political move designed to make the abortion pill more available.

The 5th Circuit Court of Appeals’ motions panel split its decision late Wednesday, putting on hold a Texas judge’s ruling that would have stopped the use of the abortion pill (specifically, Mifepristone, the first of two pills), at least temporarily. But, in a significant move, the appeals court called for safety precautions (Risk Evaluation and Mitigation Strategy or REMS) originally put on the pill by the FDA to be reinstated.

This means:

  1. The abortion pill is currently authorized for use only up to the seventh week of pregnancy.
  2. The abortion pill can only be dispensed by a licensed doctor.
  3. A woman must see a doctor before and after taking the pill a total of three times to limit factors of complication.
  4. Healthcare providers must report all adverse effects of the abortion pill.

The court panel found the FDA failed to show that dropping these critical safety precautions was not “arbitrary and capricious.” It also found unbelievable that the abortion pill is comparable to ibuprofen. The ruling stated, “Ibuprofen’s label … obviously bears no resemblance to the “Black Box” warning on mifepristone’s label.”

The “Black Box” warning label on Mifepristone is extensive, cautioning doctors to inform patients about “serious and sometimes fatal infections or bleeding” as well as incomplete abortions, sepsis, and the possible need for emergency room visits.

The ruling took seriously testimony from emergency room doctors, including one physician who saw three women suffering from serious abortion pill complications in just one month’s time. One woman was admitted to ICU for sepsis, one needed a blood transfusion for hemorrhage, and one required a surgical abortion due to an incomplete chemical abortion.

Other testimony included a patient who required serious in-hospital care after taking the abortion pill she ordered from a website without a doctor’s visit. Yet another patient was given Mifepristone from Planned Parenthood even though the woman’s previous medical history eliminated her as a candidate for the drug. The testifying doctor said the woman could have died if her Uber driver hadn’t noticed her critical state and rushed her to the ER.

The ruling criticized the FDA’s move to eliminate the requirement that doctors report adverse effects of Mifepristone, creating a gap of information. Then, based on that lack of information, the FDA deemed the drug “safe.” The court panel stated, “This ostrich’s head-in-the-sand approach is deeply troubling.”

The reinstatement of critical safeguards on the abortion pill puts women’s safety back in focus after the FDA turned a blind eye. But this is far from over. President Biden’s Department of Justice is appealing the ruling to the U.S. Supreme Court.

For what it means in Arizona, Attorney General Kris Mayes joined other state attorneys general to obtain a federal judge’s ruling out of Washington state contradicting the Texas ruling. That ruling made the abortion pill available in several states, including Arizona. While somewhat confusing, our read is that  Arizona clinics and doctors should abide by the reinstated REMS so not to inadvertently break the law.

To recap, in Arizona, the abortion pill remains legally available, but the reinstated FDA precautions listed above must be followed. With the conflicting rulings, the U.S. Supreme Court may honor the DOJ’s request and take the case. We will keep you informed.


  • Read here Alliance Defending Freedom’s (ADF) take on the ruling. ADF represents the plaintiff doctors in this case.
  • Read here for more analysis of the ruling.
  • Read or listen here to Al Mohler’s excellent take on the Texas case.
  • Read here how Minnesota may follow California’s lead and take custody of out-of-state children trying to “transition” and provide them puberty blockers, cross-sex hormones, and irreversible surgeries.

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