Abortion Pill Mifepristone Won’t Lose Approval—At Least For Now—As Appeals Court Partially Blocks Controversial Ruling

Topline

Abortion drug mifepristone will remain available nationwide, at least for now, as an appeals court paused partially put on hold a controversial lower court ruling that blocked the medication’s federal approval, ensuring restricted access to the drug at least while the appeals process plays out.

Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in … [+] Amarillo, Texas, on March 15.

AFP via Getty Images

Key Facts

The 5th Circuit Court of Appeals’ ruling put on hold U.S. District Judge Matthew Kacsmaryk’s controversial decision to suspend FDA approval of the drug.

Kacsmaryk ruled Friday to block the Food and Drug Administration’s approval of mifepristone, one of two drugs used in a medication abortion, siding with anti-abortion rights challengers who argued the FDA did not have authority to approve the drug.

The appeals court, however, allowed other parts of the Texas federal judge’s ruling which restores many of the restrictions placed on access to the drug prior to 2016.

Other portions of Kacsmaryk’s ruling will take effect on Friday after which access to the pill will require at least three in-person doctor visits and its usage will be restricted to the first seven weeks of pregnancy—down from 10 weeks currently.

The administration asked the appeals court to rule by noon on Thursday, arguing that letting Kacsmaryk’s ruling stand “would thwart FDA’s scientific judgment and severely harm women.”

The plaintiffs in the case asked the 5th Circuit to reject the Biden Administration’s appeal, arguing Kacsmaryk’s ruling was “meticulously considered” and should be left in place and claiming there were procedural issues with how the appeal was filed.

What To Watch For

The 5th Circuit’s ruling doesn’t overturn Kacsmaryk’s decision but it does buy the Biden Administration more time to appeal the ruling without it taking effect, and the White House signaled in its brief to the appeals court that it intends to go to the U.S. Supreme Court to seek relief if needed. If the appeals court or the Supreme Court does ultimately rule against mifepristone’s approval, it’s still hard to say what the decision will look like in practice, given the unprecedented nature of the courts trying to override the FDA approval of a medication. Legal experts have suggested the ruling could just trigger the FDA’s process for withdrawing approval for a drug, which could take months or years, and some lawmakers have suggested the White House ignore the ruling and say the FDA’s authority should take precedence. The Biden Administration has rebuffed those calls, saying it would “set a dangerous precedent.” If access to mifepristone is cut off, many abortion providers have said they intend to switch to providing medication abortions using only misoprostol, which is typically used in combination with mifepristone for medication abortions. That drug is more readily available, as it’s also used to treat other conditions like ulcers, and can be used for medication abortions on its own, just with slightly lower efficacy and more side effects.

What We Don’t Know

A second case concerning mifepristone is also playing out in Washington, where a judge ruled quickly after Kacsmaryk’s ruling Friday to actually expand access to the abortion drug in 17 Democratic states and Washington, D.C. That ruling directly conflicts with Kacsmaryk’s ruling, and the Biden Administration has asked the court to clarify how to square the two rulings with each other given the “significant tension.” A hearing on that request is scheduled for Monday.

Big Number

53%. That’s the percentage of all abortions in the U.S. that were medication abortions in 2020, the most recent year for which data is available, according to the pro-abortion rights Guttmacher Institute. Of those, researchers for the Guttmacher Institute found more than 98% were done using both mifepristone and misoprostol.

Key Background

Medication abortion using a combination of mifepristone and misoprostol—which are used to terminate a pregnancy and then induce contractions to expel the tissue, respectively—has been approved by the FDA since 2000, and numerous studies have found the regimen to be overwhelmingly safe and effective. Abortion pills have become more important to abortion access since the Supreme Court overturned Roe v. Wade in June, prompting states across the country to ban the procedure and shuttering abortion clinics across the country. Abortion pills have been easier to access for people living in states where the procedure is banned or far from a clinic performing surgical abortions, and VICE News reports at least 20,000 packets of abortion pills are believed to have been shipped nationwide through covert means in the six months following the court’s ruling. Attacks on medication abortion have ramped up as a result, and lawmakers have introduced bills targeting the drugs in addition to the lawsuit against mifepristone’s federal approval. Wyoming became the first state to enact a specific ban on abortion pills in March.

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