CNN –
The Supreme Court is being asked again in an election year to make a major decision on abortion.
A maker of the widely used abortion drug mifepristone asked the Supreme Court on Friday to overturn a lower court ruling that, if taken into effect, would limit access to the drug.
The filing, obtained by CNN, means the justices could finally rule on the long-running abortion dispute next summer, which could put the court at the center of US presidential and congressional politics.
As it currently stands, mifepristone remains available and is not subject to restrictions that lower courts have ruled should apply to its use pending resolution of all legal challenges under an order signed by the justices in April. The majority of abortions performed in the United States are medical terminations.
Jessica L. Ellsworth, an attorney for Danco Laboratories, a manufacturer of the drug and an intervener in the case, told the justices in court papers: “For the women and teenage girls, health care providers and states who rely on FDA’s actions to To ensure safety.” Given the existence of effective reproductive health care, this case is of enormous importance.”
She said the court should address the dispute because it “impacts the availability of a lawful use drug in states across the country” and “raises the question of whether a single federal court will restrict access to abortion in the states that protect it.” , can restrict.”
A decision last month by the conservative 5th U.S. Circuit Court of Appeals “destabilizes” the pharmaceutical and biotechnology industries “by calling into question when scientific studies – accepted by the FDA – are sufficient to support conditions of use,” Ellsworth added.
The Biden administration, which is also involved in the case, has previously said it also plans to appeal.
The case is the most important abortion-related dispute to come before the justices since the landmark 2022 decision that overturned Roe v. Wade and led 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.
At the heart of the dispute is the extent of the Food and Drug Administration’s authority to regulate mifepristone, a drug considered safe and effective by the medical community. It has been used by millions of women across the country in the more than two decades it has been on the market.
Last month, a three-judge panel of the 5th Circuit rejected the request to remove the drug from the market, ruling that a challenge to the FDA’s original approval in 2000 was barred by the statute of limitations. However, the court’s decision would still complicate access to the drug because the changes made by the FDA in 2016 and 2021 that expanded access to the pills were arbitrary, capricious and violated federal law.
If the Court of Appeal decision ultimately stands, the time limit for receiving mifepristone will shorten from 10 weeks to 7 weeks – although some prescribers may prescribe off-label after 7 weeks. Dosages are changed from 200 mg to 600 mg, which the FDA says is higher than necessary.
It would not be available by mail, and administration of mifepristone must be performed by a physician and not by other people authorized by state law to prescribe drugs, including a midwife, physician’s assistant or nurse practitioner.
The legal controversy began when a group of anti-abortion doctors filed a lawsuit arguing that the FDA had not done enough to ensure the drug’s safety about two decades earlier.
Last year, Trump-appointed U.S. District Court Judge Matthew Kacsmaryk issued a sweeping ruling that blocked the drug’s approval and the changes the FDA made in subsequent years to make the drug more accessible. In a preliminary ruling, the federal appeals court reversed the district court’s ruling but said the drug could be restricted during the appeal process. At this point in the case, advocates for the drug asked the Supreme Court to freeze the order while the appeal process was underway.
The judges agreed and protected access to the drug while the case was remanded to the Court of Appeals.
After last month’s ruling, the Biden administration and the manufacturer had several weeks to file their appeal according to normal procedures, but opted to file the lawsuit early, perhaps to ensure the judges had time to address the issue to add to their calendar this semester, meaning a likely decision in 2024.
In its recent decision, the Court of Appeal upheld most of the procedural arguments raised by plaintiffs regarding the appropriateness of judicial intervention. The opinion also included claims about mifepristone’s risks made by anti-abortion doctors who challenged the FDA approval, even though those characterizations had been widely rejected by mainstream medical groups.
The court concluded that the FDA’s moves to relax pill regulations should be reversed, writing: “The public interest is violated by a drug that does not provide adequate protection to its users.”
“To be clear, the evidence does not show that mifepristone is unsafe in all uses,” the appeals court said. “But in this filing and at this preliminary stage, the medical organizations and physicians have clearly demonstrated that the 2016 changes and the 2021 non-enforcement decision were made without sufficient consideration of the impact these changes would have on patients.”
This story has been updated with additional details.