The Supreme Court agreed to take up a case on Wednesday focused on a common abortion pill manufacturer after a lower court put in place restrictions on how the drug should be used and distributed.
The case surrounds mifepristone maker Danco Laboratories, and it follows months of litigation that stemmed from a federal district judge’s decision in Texas in April to suspend the Food and Drug Administration‘s approval of the pill.
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Mifepristone is the first pill in a two-pill chemical abortion series, blocking a woman’s progesterone receptors to stop fetal growth. The second pill, misoprostol, induces contractions to expel the fetus.
The FDA loosened the restrictions on mifepristone in 2016 to allow for the abortion agent to be used up to 10 weeks of pregnancy and in 2019 approved the generic medication mifepristone.
During the early stages of the COVID-19 pandemic, a federal district court judge in 2020 issued a preliminary injunction to prevent the FDA from enforcing the agency’s rule that a prescription for mifepristone required both an in-person evaluation and the patient to pick up the prescription in person. The FDA codified these looser requirements in Jan. 2023, permanently expanding by-mail access to the abortifacient.
The 5th Circuit in August 2023 rolled back part of the Texas district judge’s ruling by keeping in place the original FDA approval of mifepristone from 2000 but rejecting the changes the FDA made in 2016 and afterward. The circuit court also maintained the agency’s authorization of the generic form of the drug.
A group of anti-abortion providers that brought the suit, represented by the conservative legal firm Alliance Defending Freedom, urged the high court not to take up the case.
“FDA’s early actions in approving mifepristone are inextricably intertwined with its more recent decisions to remove critical safeguards surrounding its use,” the group wrote. “To review one without the other is like reading a novel starting in the middle.”
Erin Hawley, senior counsel at ADF, told the Washington Examiner “every court” from the district level to the 5th Circuit “has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions.”
“We urge the Supreme Court to do the same,” Hawley added.
Meanwhile, the Biden administration has warned that disrupting the drug’s original 2000 approval would have lasting impacts that could call into question the FDA’s broader authority. “FDA approved mifepristone as safe and effective in 2000,” according to the Justice Department’s court filings.
Mifepristone is expected to remain on the market while the high court considers the case.
Although chemical abortions can be induced by misoprostol alone, the single-agent method causes the patient significantly more bleeding and cramping. Abortion advocates fear that access to misoprostol will also be restricted if access to mifepristone is successfully limited.
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Last year, the 6-3 Republican-appointed majority made the historic decision to overturn the precedent set under Roe v. Wade, allowing states to impose stricter rules on access to abortion in the case known as Dobbs v. Jackson Women’s Health Organization.
A decision over the drug’s approval ahead of the 2024 presidential election will likely add a new dynamic for voters considering who to choose as president, as President Joe Biden has championed access to abortion and chastised the Supreme Court’s conservative supermajority that was installed by former President Donald Trump, his likely 2024 challenger.
