The FDA approved mifepristone under the brand-name Mifeprex. (Photo by Peter Dazeley/GettyImages).
WASHINGTON — The U.S. Department of Justice on Friday asked the Supreme Court to decide whether the abortion pill should remain on the market after two lower courts issued differing opinions about its use.
The case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, will likely be the second time the conservative-leaning Supreme Court rules on access to abortion since former President Donald Trump nominated three new justices, shifting the balance of power.
“The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation,” the DOJ wrote in the 42-page document. “For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma.”
“Surgical abortion is an invasive medical procedure that can have greater health risks for some patients, such as those who are allergic to anesthesia,” DOJ added.
The DOJ called on the Supreme Court to take up the case by arguing that lower courts erred in several ways, including by making “serious legal errors.”
“The court scarcely acknowledged FDA’s detailed analysis of the available scientific evidence,” DOJ wrote. “Instead, it faulted FDA for failing to cite studies that do not exist and for failing to explicitly respond to unfounded objections that were not raised during the administrative process.”
Alliance Defending Freedom, an anti-abortion legal organization, filed the lawsuit in November on behalf of four anti-abortion medical organizations and four anti-abortion doctors.
The case argued the U.S. District Court for the Northern District of Texas should overturn the U.S. Food and Drug Administration’s 2000 approval of mifepristone, the first of two drugs used in medication abortion.
The original filing in the case said that if the judge didn’t end legal access to mifepristone, the court should revert prescribing and dosage to what was approved before 2016.
District Court Judge Matthew Joseph Kacsmaryk issued a ruling in April that essentially overturned the FDA’s 2000 approval of mifepristone, which is also commonly used in miscarriage treatment.
The U.S. Supreme Court later issued a temporary stay of that ruling, keeping mifepristone on the market until the justices decide whether to take up the case as part of the appeals process.
The three-judge panel, made up of Republican-nominated judges, rejected the district judge’s decision to overturn the FDA’s 2000 approval of mifepristone. But the appeals court ruled the FDA should revert prescribing and dosage to what was in place before 2016.
The 5th Circuit wrote in its opinion that 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.”
“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the appeals judges wrote. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
That ruling remains on hold until the Supreme Court issues its own opinion, or refuses to hear the case. That means mifepristone remains an FDA-approved drug that health care providers can continue prescribing in line with current standards.
If the Supreme Court orders the FDA to revert to pre-2016 use and dosage of mifepristone, it would lead to several changes.
Mifepristone could only be used to end a pregnancy in patients up to seven weeks gestation, not the current 10-week benchmark.
Only doctors, not other healthcare providers with the authority to prescribe medications, would be able to administer mifepristone.
Patients would need to attend three in-person doctor’s office visits, removing the option to prescribe the drug via telehealth and send it to patients through the mail.
The dosage of mifepristone would revert to what was used before 2016, as would the timing of when patients take a second medication known as misoprostol.
A Department of Justice spokesperson said following the appeals court’s ruling in August that the “Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA and will be seeking Supreme Court review of that decision.”
In the writ of certiorari the Department of Justice sent to the Supreme Court on Friday asking the justices to hear the case, its attorneys argued that the 5th Circuit decision could have “especially disruptive implications for the pharmaceutical industry and those who depend upon the drugs it supplies.”
“Indeed, a wide range of industry participants have warned that the lower courts’ approach would ‘result in a seismic shift in the clinical development and drug approval processes, erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing the rigorous, well-established, and long-standing drug approval process.’”
The Department of Justice lawyers also wrote the 5th Circuit decision “did not conclude that mifepristone is unsafe.”
“Instead, the court held that FDA did not adequately explain its 2016 and 2021 actions,” DOJ attorneys wrote. “Even if that were true, those asserted failures of explanation would at most have justified a direction to FDA to further consider the relevant issues, without additional relief that would bar distribution of mifepristone as presently approved.”
If the U.S. Supreme Court decides to take up the case, the justices could issue a ruling as soon as next summer, just months before the 2024 presidential election.
The Supreme Court ruled in June 2022 that Americans no longer had the constitutional right to abortion that was established nearly 50 years before in the landmark Roe v. Wade case.
The Supreme Court wrote that “the authority to regulate abortion is returned to the people and their elected representatives.”
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