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Mifepristone maker asks Supreme Court to make ultimate decision on abortion drug


The Supreme Court is once again being asked to make a major ruling on abortion in an election year.

A manufacturer of the widely used abortion drug mifepristone asked the Supreme Court on Friday to reverse a lower court ruling that, if allowed to go into effect, would restrict access to the drug.

The filing obtained by CNN that means that the justices could finally decide the long-running abortion-related dispute next summer, putting the court in the middle of US presidential and congressional politics.

As things stand, mifepristone remains available and not subject to restrictions the lower courts have said should be imposed on its use until all legal challenges are resolved because of an order the justices signed in April. Medication abortion makes up the majority of abortions obtained in the United States.

Jessica L. Ellsworth, a lawyer for Danco laboratories, a manufacturer of the drug and an intervenor in the case told the justices in court papers that “for the women and teenage girls, health care providers and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously.”

She said the court should take up the dispute because it “affects the availability of a drug with lawful uses in States across the country” and “raises questions about whether a single federal court can limit abortion access in the States that protect it.”

A decision by the conservative 5th US Circuit Court of Appeals last month “destabilizes” the pharmaceutical and biotechnology industries “by questioning when scientific studies – accepted by FDA – are sufficient to support conditions of use,” Ellsworth added.

The Biden administration, also a party to the case, has said previously that it also plans to appeal.

The case is the most important abortion related dispute to come before the justices since the landmark decision in 2022 that overturned Roe v. Wade and triggered conservative states across the country to either ban or severely restrict the procedure. The new case could make it harder for women to access abortion even in states that still allow it.

Central to the dispute is the scope of the Food and Drug Administration’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective. It has been used by millions of women across the country in the more than two decades its been on the market.

Last month, a three judge panel on the 5th Circuit rejected a claim that the drug should be taken off the market, deciding that a challenge to the FDA’s initial approval in 2000 is barred by the statute of limitations. But the court’s ruling would still make it more difficult to access the drug, holding that changes the FDA undertook in 2016 and 2021 that expanded access to the pills were arbitrary and capricious in violation of federal law.

If the appeals court decision is ultimately allowed to stand, the window to obtain mifepristone will narrow to 7 weeks from 10 weeks – although some prescribers might prescribe off-label beyond 7 weeks. Dosages will change from 200mg to 600mg which the FDA says is higher than necessary.

It would not be available by mail, and the administration of the mifepristone will have to be done by a doctor instead of others authorized to prescribe drugs under state law, including a midwife, physician assistant or nurse practitioner.

The legal controversy began when a group representing doctors who oppose abortion filed suit arguing that the FDA had not done enough to ensure the safety of the drug some two decades earlier.

Last year, US District Court Judge Matthew Kacsmaryk, a Trump appointee, issued a broad ruling blocking approval of the drug as well as the changes the FDA made in subsequent years to make the drug more accessible. In a preliminary ruling, the federal appeals court scaled back on the district court ruling but said the drug could be restricted while the appeal process played out. At that juncture in the case, supporters of the drug asked the Supreme Court to freeze the order while the appeals process played out.

The justices agreed to do so, protecting access to the drug as the case went back to the appeals court.

After last month’s ruling, the Biden administration and the manufacturer had several weeks to file their appeal under normal procedures, but chose to file early perhaps to ensure that the justices had the time to add the issue to their calendar this term, meaning a likely ruling in 2024.

In its most recent decision the appeals court endorsed most of the procedural arguments that the challengers made for why it was appropriate for a court to intervene. The opinion also embraced claims about mifepristone’s risks, put forward by anti-abortion doctors challenging the FDA approval, even though those characterizations had been widely rebuked by mainstream medical groups.

In concluding that FDA’s moves to relax the pills’ regulations should be reversed, the court wrote, “the public interest is disserved by a drug that does not afford adequate protections to its users.”

“To be clear, the evidence does not show that mifepristone is unsafe in all applications,” the appeals court said. “But on this record and at this preliminary stage, the Medical Organizations and Doctors have made a substantial showing that the 2016 Amendments and 2021 Non-Enforcement Decision were taken without sufficient consideration of the effects those changes would have on patients.”

This story has been updated with additional details.

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