The abortion drug tug-of-war

The U.S. Supreme Court issued an order Friday in the case Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that will allow the abortion drug mifepristone to remain widely available for now. Let’s break down what’s happened so far in this case and what could happen in the coming months.

How did we get here? The Supreme Court made its order in response to requests from the Biden administration and mifepristone manufacturer Danco Laboratories—the defendants in a lawsuit challenging the drug’s initial Food and Drug Administration approval in 2000 and recent relaxations to distribution rules. Both parties asked the court to block lower court rulings that favored the pro-life doctors who brought the lawsuit.

On April 7, a federal judge in Amarillo, Texas, issued an order that would have paused FDA approval of the drug on April 14. Upon appeal from the defendants, the 5th U.S. Circuit Court of Appeals agreed on April 12 that it was likely too late for pro-life doctors to challenge the FDA’s approval, which it granted 23 years ago. But a panel of judges from that court upheld parts of the lower court order that would have required the FDA to reimplement safety requirements that it had from 2000 to 2016, before the agency began relaxing rules for mifepristone distribution. Friday’s order from the Supreme Court, though, means nothing changes for now.

Could mifepristone become unavailable later? The Supreme Court’s order is temporarily in effect while the 5th Circuit considers an appeal in the case. Those oral arguments are scheduled for May 17. That court could rule to halt the initial FDA approval of the drug or at least reinstate previous safety restrictions. But if that happens, the FDA and Danco are likely to appeal for a temporary reprieve—again—from the Supreme Court. Alliance Defending Freedom senior counsel Erik Baptist said it could be years before this case fully resolves.

What other legal battles are going on over the abortion pill? On Wednesday, the company GenBioPro, the manufacturer of the generic version of mifepristone, filed a lawsuit against the FDA in a federal court in Maryland. Had the orders from the court in Texas and the 5th Circuit in the Alliance for Hippocratic Medicine case taken effect, they would have required GenBioPro to stop marketing its generic version of mifepristone, which the FDA approved in 2019.

The company wrote to the FDA, asking the agency for “assurances” that it wouldn’t immediately revoke GenBioPro’s approval should a court order pause the 2019 approval for the generic version. The company requested that the FDA instead put GenBioPro through the standard procedures for withdrawing approval. The lawsuit said the company received no such assurances, thereby leaving it “at risk of severe civil and criminal penalties” and suffering “threats to its core business and irreparable financial harm.”

There’s also an ongoing federal case in Washington state filed against the FDA by 17 pro-abortion states and the District of Columbia. On April 7, U.S. District Judge Thomas Rice ruled that the FDA could not alter the availability of mifepristone in the 18 jurisdictions that filed the lawsuit. But he declined to apply that ruling nationwide and did not discard the existing safety precautions for mifepristone distribution. Proceedings have since continued in the case at the district court level.

What else are pro-life groups doing to protect unborn babies from drug-induced abortions? On Wednesday, Students for Life of America filed a citizen petition with the FDA to contest the agency’s approval of mifepristone in 2000 on the grounds that the agency didn’t do its homework to find out how the drug would affect the environment. According to the petition, the FDA stated that “adverse effects are not anticipated upon endangered or threatened species” but didn’t provide further explanation. The pro-life group urges the agency to revoke this approval until it consults the U.S. Fish and Wildlife Service and the National Marine Fisheries Service about the drug.

The petition also noted that, before granting approval of mifepristone in 2000, the FDA said it would establish high standards for disposal of drug-related waste.

“This has not been the case,” Students for Life argued, adding that mifepristone and the remains of aborted babies in wastewater could negatively affect animals and people. “The [abortion] industry’s practice to date is to allow the byproducts of mifepristone usage to be flushed into the patient’s toilet, as is the FDA’s,” the petition said, “but everything that is flushed goes into America’s wastewater system.”

How will chemical abortions change if mifepristone comes off the market? Women will likely continue to access mifepristone even if it becomes unavailable in the United States. Since 2018, the European group Aid Access has been shipping mifepristone and its companion drug misoprostol to U.S. women. Requests to the website increased after the Supreme Court overturned Roe v. Wade in June 2022. In addition, pro-abortion states are stocking up on abortion pills in preparation for mifepristone possibly becoming unavailable. Oregon Gov. Tina Kotek announced Thursday that the state would secure a three-year supply of mifepristone, joining states such as Washington and Massachusetts in stockpiling the drug.

Abortionists have also floated the idea of facilitating misoprostol-only abortions. While mifepristone effectively starves the unborn baby of vital nutrients, misoprostol induces contractions that expel the baby. Using misoprostol alone is a common form of chemical abortion in underdeveloped countries. But it can often result in incomplete abortions that require surgery to fully remove the baby’s remains. Some women who have experienced the effects of misoprostol fear that using that drug alone for chemical abortions will increase the physical dangers for women beyond the existing dangers for unborn babies.