Appeals court backs limits on access to abortion pill mifepristone, ruling against Biden's FDA

WASHINGTON − A federal appeals court on Wednesday said it would limit access to the abortion pill mifepristone, ruling that the Food and Drug Administration had overstepped its authority with a series of actions that made it far easier for Americans to obtain the drug, such as allowing prescriptions to be filled by mail.

But the ruling was unlikely to have an immediate impact on access to the drug because of an earlier Supreme Court decision that paused any changes to the status quo. The appeals court ruling does, however, set up another showdown at the Supreme Court over access to the drug – and abortion.

The ruling from the three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals, all three of whom were nominated by Republican presidents, was the latest step in what has turned into a monthslong legal drama over mifepristone. The fight over the drug took on added significance as conservative states banned abortion in response to the Supreme Court's decision last year to overturn Roe v. Wade.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions," said Erin Hawley, vice president of the Alliance Defending Freedom, a conservative group that sued over the FDA's approval of the drug.

The Justice Department said in a statement it would appeal the ruling to the Supreme Court and vowed to defend the FDA’s scientific judgment as well as access to reproductive care.

“This appeals court decision sets up a showdown at the Supreme Court over baseless attacks on medication abortion, which has been a lifeline since the high court reversed Roe last year," said Nancy Northup, president and CEO of the Center for Reproductive Rights.

What the 5th Circuit ruled on mifepristone

The appeals court panel waved off part of the lawsuit that challenged the FDA's underlying approval of the drug, ruling that it was likely barred by the statute of limitations. It also allowed the FDA's approval in 2019 of a generic version of the drug to stand.

But the panel affirmed a U.S. District Court ruling that blocked a move by the FDA in 2021 to allow the drugs to be dispensed through the mail. The appeals court also ruled against FDA decisions in 2016 to let pregnant people take the drug three weeks longer into a pregnancy and to let pharmacists prescribe the drug instead of just doctors.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," the court wrote. “It failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person."

The decision drew pushback from critics who noted how unusual it is for federal courts to weigh into decisions handed down by the FDA.

"Judges are playing with fire when they interfere with medical decisions," said Lawrence Gostin, a professor of global health law at Georgetown University. "If you looked at this as a cancer drug or a heart drug, you'd know immediately and intuitively that you'd want the FDA to be making that decision, not judges or legislators."

No changes on mifepristone access for now

In April, the Supreme Court allowed full access to mifepristone while the case played out in lower courts, maintaining the status quo from before the lawsuit was filed. That short-term "stay," which doesn't necessarily signal how the court will rule on the underlying merits of the case, remains in place. It will not lift until the expected appeal to the Supreme Court is resolved.

Medication abortion accounts for about half of all U.S. abortions, and a wide array of government agencies and outside experts have said the drug is safer than common drugs such as Tylenol and Viagra. But the anti-abortion groups challenging the drug questioned those studies and argued that the FDA didn't follow its own protocols and ignored contrary data as it expedited the drug's approval.

Timeline: How the mifepristone battle got here

The legal roller coaster began in early April when a pair of federal court rulings plunged the fate of mifepristone into uncertainty. One of those rulings, from U.S. District Judge Matthew Kacsmaryk on April 7, effectively invalidated the FDA's 23-year-old approval for the drug. Days later, the 5th Circuit sided with the Biden administration on the drug's approval but let stand the parts of Kacsmaryk's ruling that halted efforts to expand access to the drug.

Among the moves to expand access: In 2016, the FDA allowed pregnant people to take the drug three weeks longer into a pregnancy. The agency allowed pharmacists to prescribe the drug instead of just doctors. In 2019, the FDA approved a generic version of the drug. In 2021, during the COVID-19 pandemic, it allowed mifepristone to be dispensed through the mail. The agency formalized that mail-order decision earlier this year.

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Then, on April 21, the Supreme Court put the lower court rulings on pause while the case continued. The appeals court heard arguments on May 17, signaling that they were prepared to limit access to the drug.

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.

Safety vs. process: What the case is about

As the mifepristone case has ricocheted through the courts, medical associations and health experts have pointed to the drug's decadeslong safety record and studies showing it to be safer than common drugs such as Tylenol and Viagra. The Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone safe and effective for abortion and miscarriage care.

The anti-abortion groups challenging the drug have questioned those studies and say the FDA didn't follow its own protocols and ignored contrary data as it expedited the drug's approval. The groups claim that the expedited procedure the FDA used to approve mifepristone was supposed to be used only for drugs treating an "illness."

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But the real fight is about access to abortion as the groups challenging the drug made clear in their arguments to the appeals courts. The FDA's approval of mail-order abortion drugs, the group said, "subvert the promise" of the Supreme Court's decision last year to overturn Roe v. Wade, empowering states to decide whether to ban abortions. Those state decisions, the group said, are "rendered meaningless by FDA's mail-order abortion scheme."

The Biden administration, not surprisingly, sees it differently. It argued approval was based on clinical trials involving more than 2,500 people and that the drug's decadeslong use by over 5 million Americans underscores its safety. Allowing courts to overturn FDA drug approvals "without regard for science or evidence," it said, would add an intolerable dose of politics to the nation's pharmaceutical system.

Contributing: Christine Fernando

Contributing: Karen Weintraub

This article originally appeared on USA TODAY: Court backs limits on abortion pill mifepristone, ruling against Biden