Supreme Court preserves full access to medical abortion pill mifepristone

After delaying its decision earlier this week, the Supreme Court on Friday ruled that full access to the abortion pill mifepristone can continue as a lawsuit works its way through the lower federal courts.

Mifepristone was approved by the Food and Drug Administration (FDA) in 2000, and its use has been deregulated in recent years. Under President Biden, the FDA made abortion pills more widely available at retail pharmacies, including delivery by mail. 

The ruling by the Supreme Court gives a victory to the Biden administration and supporters of abortion rights, but the Supreme Court will likely be asked to revisit the issue later this year.

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The case challenging the FDA’s approval of mifepristone, brought by pro-life doctors and medical groups, is the first abortion controversy to be heard by the Supreme Court since the Republican-appointed majority overturned Roe v. Wade 10 months ago and permitted more than a dozen states to effectively ban abortion outright.

In that decision, Justice Samuel A. Alito, Jr. said abortion policy should be a question for lawmakers to consider, not courts. 

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“It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives,” Alito wrote.

In this case, the issue is not abortion pills directly, but whether the FDA acted appropriately in approving the drug more than 20 years ago. The Alliance Defending Freedom, which represents the pro-life plaintiffs, alleges the FDA “chose politics over science” in approving the drug and acted unlawfully by removing safeguards around mifepristone, including permitting the pill to be delivered by mail.

A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kan., Oct. 12, 2022. (AP Photo/Charlie Riedel, File)

The Biden administration and Danco Laboratories, the drug’s manufacturer, counter that mifepristone has been repeatedly found to be safe and effective by FDA’s expert review process. In over two decades since it was first approved, the drug has been used by more than 5 million women to terminate pregnancies.  

The case reached the Supreme Court after Trump-appointed U.S. District Judge Matthew J. Kacsmaryk issued a highly controversial ruling siding with the pro-life groups and halting FDA approval for mifepristone. His order was partially overturned by the 5th U.S. Circuit Court of Appeals, but the appeals court preserved restrictions that made the drug available only to be dispensed up to seven weeks, not 10, and not by mail.

The Justice Department argued that allowing restrictions to mifepristone imposed by the lower courts to remain in place would cause chaos. Complicating the matter, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in response to a separate lawsuit brought by 17 Democratic-led states and the District of Columbia. 

The Biden administration has said the rulings conflict and create an untenable situation for the FDA. 

In a new development, the generic abortion pill maker GenBioPro Inc. filed a lawsuit against the FDA Wednesday to keep mifepristone available on the market amid the other ongoing legal challenges. 

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Mifepristone is taken with misoprostol in a two-drug regimen that first blocks hormones needed to keep an unborn baby alive and then causes cramps and contractions to expel the dead fetus from the mother’s womb. 

The drug is 97% effective in terminating early pregnancy, though approximately 3% of women who take it will “require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion or other reasons such as patient request,” according to the manufacturer. 

The Associated Press contributed to this report.