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FDA erred in easing access to abortion pill, appeals court rules


NEW ORLEANS (BP) — The Food and Drug Administration erred in easing access to the so-called abortion pill, a federal appeals court ruled Aug. 16 in a decision that will have no impact unless the U.S. Supreme Court agrees.

But the Fifth Circuit’s three-judge panel reversed a lower court’s ruling that mifepristone should be removed from the market in both its brand name and generic forms. The statute of limitations has likely expired regarding any challenges to the 2000 approval of Mifeprex, and the plaintiffs had not shown they were injured by the 2019 approval of the generic drug, the Fifth Circuit ruled.

The decision is automatically stayed because the High Court ruled effectually in April that access to the drug – used in abortions, miscarriages and other gynecological concerns – must remain in place until appeals work their way through the courts.

The Ethics & Religious Liberty Commission (ERLC) praised the Fifth Circuit’s ruling and expressed hopes that the U.S. Supreme Court upholds it.

“We anticipate this ruling will be appealed to the U.S. Supreme Court and pray the court will uphold this ruling from the 5th Circuit, which would end the court’s emergency order that currently keeps mifepristone on the market with no restrictions,” said ERLC Policy Manager Hannah Daniel. “If upheld, this decision from the Fifth Circuit will save more preborn lives and protect women from the dangers intrinsic to chemical abortions.

“While we will continue to work towards a day when chemical abortions are no more,” Daniel said Aug. 16, “today’s ruling is a step forward in our work to build a true culture of life and to protect the health, safety, and welfare of women and girls.”

If the ruling stands, the law will:

  • Limit use of the drug to the first seven weeks of pregnancy, as opposed to the current 10-week limit.
  • Require the drug only be dispensed in a doctor’s office, ending mail-order prescriptions.
  • Require in-person doctor’s office visits for the drug to be prescribed.

The Fifth Circuit’s ruling came in a complicated administrative law appeal hinging on the initial 2000 approval of Mifeprex, 2016 amendments that lifted certain drug safety procedures, the 2019 approval of the drug’s generic form, and the 2021 COVID-19-era change that lifted requirements that the drug only be dispensed in person. The 2021 change was extended in January.

The ERLC explained likely next steps in the intricate proceedings.

The case began in November 2022 when the Alliance Defending Freedom (ADF) filed suit against the FDA on behalf of four pro-life medical groups. The medical groups claimed the FDA “failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States,” and that the FDA “has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

“This case now likely heads on appeal to the full 5th Circuit and then almost certainly back to the U.S. Supreme Court,” the ERLC explained at erlc.com. “The court’s previous 7-2 ruling in April was narrowly focused on the availability of mifepristone as litigation proceeded and did not look at the broader merits of the case. At this time, it is unclear how quickly the court could hear and decide this case.”

The case, the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, is not the only court case in play regarding mifepristone.

Still active is Washington v. United States Food and Drug Administration, filed in February in U.S. District Court for the Eastern District of Washington. There, 12 states and the District of Columbia challenge the FDA’s current restrictions on the use of mifepristone, claiming the restrictions are unfairly prohibitive.

The plaintiffs “alleged that the (January 2023) Risk Evaluation and Mitigation Strategy restrictions on mifepristone were irrational, not backed by science, and singled out pregnant people and their healthcare providers for different, harsher treatment than other patients,” according to a summary of the lawsuit at the Civil Rights Litigation Clearinghouse.