The abortion pill’s two-decade journey to court

Dr. Donna Harrison was on her way home from a Good Friday church service last week when she saw a text from a fellow pro-life OB-GYN, Dr. Christina Francis: Check your email. We won.

Harrison, Francis, and several other pro-life doctors submitted declarations in a November lawsuit against the Food and Drug Administration over the agency’s approval of the abortion drug mifepristone. According to the lawsuit, the FDA rushed approval of the drug in 2000 despite evidence that it would endanger U.S. women and girls who undergo chemical abortions.

On Friday night, U.S. District Judge Matthew Kacsmaryk for the Northern District of Texas released an initial ruling in the case, pausing FDA approval and subsequent expansion of mifepristone as the case continues. Kacsmaryk’s opinion is a key victory to pro-life medical organizations in their yearslong pushback against what has become the most common form of abortion. To give the defendants in the case time to appeal the ruling, the order will not take effect until Friday. The case could end up at the U.S. Supreme Court, where the justices might have to sort out if and how Kacsmaryk’s opinion conflicts with a recent ruling in a separate abortion pill case.

For Harrison, this victory was almost three decades in the making. She first heard about efforts to introduce the drug RU-486—also known as mifepristone—to the United States in the mid-1990s and started reading all the research she could find about the chemical compound. Soon afterwards, in 1996, the pro-abortion, pro-eugenics Population Council submitted a new drug application to the FDA for mifepristone. Meanwhile, Harrison was learning that the risks to women who took the drug included life-threatening conditions such as hemorrhage and infection from an incomplete abortion.

“That was all very, very clear from the scientific literature, way back in 2000 … and the FDA completely ignored it,” said Harrison.

On Sep. 28, 2000, the FDA approved the abortive drug under an accelerated process reserved for introducing drugs that treat life-threatening illnesses. It also omitted requirements for distributing mifepristone that were in place during the clinical trials, including required ultrasounds to make sure unborn babies were early enough in their development to avoid complications caused by an incomplete abortion. Retained pieces of the baby’s body in the uterus can cause life-threatening infections for the mother.

Harrison said the approval exposed a lack of integrity at the FDA that surprised her. “They approved a drug which treats nobody,” she said. “It actually causes the death of one of our patients and hurts the second.”

Two years later, Harrison’s findings appeared in a joint citizens’ petition submitted to the FDA that took issue with the drug’s approval. It requested the FDA to “immediately stay the approval of [mifepristone], thereby halting all distribution and marketing of the drug.”

The agency’s response was anything but immediate. The FDA didn’t get back to the petitioners until 2016. When it did, the FDA rejected the petition and at the same time loosened restrictions on the abortion pill. Subsequent petitions also faced delays as the government continued to relax the safety requirements for distributing mifepristone.

Judge Kacsmaryk outlined this timeline of events in Friday’s decision and issued a stay on the FDA’s 2000 approval of the abortion pill and every other agency action related to that approval. In the 67-page opinion, he rejected arguments from the FDA and abortion pill distributor Danco Laboratories that claimed the pro-life doctors acting as plaintiffs did not have standing to sue and were too late to file the lawsuit. He categorized the FDA’s slow-walked responses to the citizens’ petitions as “16 years of delay, dawdle, and dithering.”

In his critique of the agency’s rushed approval process for the drug, Kacsmaryk listed the other drugs that received accelerated approval by early 2002, which mostly included treatments for HIV, cancer, and bacterial infections. He agreed with the plaintiffs that the FDA shoehorned pregnancy into the category of a “serious or life-threatening illness” in approving mifepristone through this process. “One of these things is not like the others, one of these things just doesn’t belong,” wrote Kacsmaryk, quoting a recurring skit on Sesame Street.

Also on Friday night, U.S. District Judge Thomas Rice issued an opinion in a separate abortion pill case out of Washington state. In that case, 17 states plus Washington, D.C., sued the FDA in an attempt to prevent the agency from taking action that could revoke approval of the abortion drug or make it less accessible. The lawsuit also sought to remove existing restrictions on the distribution of mifepristone. Rice in his opinion ordered that the FDA cannot alter the availability of mifepristone in the 18 jurisdictions that filed the lawsuit. But he declined to issue a nationwide injunction and did not discard the existing safety precautions for mifepristone distribution.

The final outcomes of both cases are still up in the air. “You’re going to see a lot of activity in the next five days,” said Alliance Defending Freedom senior counsel Erik Baptist, the lawyer who represented the pro-life physicians during last month’s oral arguments in the Texas case. On Monday, Danco and the U.S. Department of Justice filed emergency motions at the U.S. Court of Appeals for the Fifth Circuit, asking the court to intervene. If the appeals court does not stop Kacsmaryk’s order from going into effect, Baptist said he expects the FDA and Danco to seek emergency relief from the U.S. Supreme Court by Friday, before the preliminary injunction takes effect.