Appeals court rules abortion pill can remain on market with restrictions

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A federal appeals court on Wednesday said it would restrict access to a widely used abortion medication after finding that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available.

A three-judge panel of the conservative U.S. Court of Appeals for the 5th Circuit said Food and Drug Administration decisions to allow the drug mifepristone to be taken later in pregnancy, be mailed directly to patients and be prescribed by a medical professional other than a doctor were not lawful.

Despite the court’s ruling against the government and the drug manufacturer, mifepristone will remain available for now under existing regulations while the litigation continues, in accordance with a Supreme Court ruling this spring. Wednesday’s decision is likely to be appealed to the Supreme Court.

Mifepristone is part of a two-drug regimen used in more than half of U.S. abortions and first approved for use in this country more than 20 years ago. The legal battle over the medication has intensified since the Supreme Court overturned Roe v. Wade’s grant of a constitutional right to abortion last June, a decision that spurred multiple states to further limit or ban the procedure.

The challenge to mifepristone was brought by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others. The group asserted that the FDA did not sufficiently consider safety concerns when it approved the drug or when it subsequently removed some restrictions — extending the approved use of mifepristone, for instance, through 10 weeks of pregnancy instead of seven.

The lawsuit, was filed in Amarillo, Tex., where U.S. District Judge Matthew Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge. He issued an unprecedented ruling, for the first time suspending FDA approval of a human drug over objections from the agency. Kacsmaryk’s mifepristone opinion embraced language used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”

The Justice Department, representing the FDA, and the drug manufacturer Danco Laboratories appealed Kacsmaryk’s ruling to the 5th Circuit. They emphasized the FDA’s reliance on dozens of studies involving thousands of patients to approve the medication, which has been used by more than 5 million women. Serious side effects occur in fewer than 1 percent of patients.

Lawyers defending the drug said the antiabortion challengers had no legal right — or standing — to file the lawsuit because they were not directly harmed by the FDA’s approval of the abortion pill. They also argued that allowing a court to revoke approval of an approved medication would jeopardize access to non-abortion drugs and more broadly harm medical research and innovation.

At oral argument in May, all three judges, who previously supported abortion restrictions, seemed prepared to limit access to the medication.

In an initial review of Kacsmaryk’s opinion, a separate three-judge panel of the 5th Circuit declined to suspend approval of mifepristone but reversed actions taken by the FDA since 2016 to loosen restrictions on how to obtain the medication.

The Supreme Court temporarily put that appeals court decision on hold, opting to leave the current FDA regulations for mifepristone in place while the litigation continues.

This is a developing story. It will be updated.

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