“This is a dangerous precedent for FDA’s scientific review authority,” said Kirsten Moore, an advocate for medication abortion.
The Fifth Circuit Court of Appeals released a decision on Wednesday, Aug. 16, that dismissed a challenge to the U.S. Food and Drug Administration’s 2000 approval of mifepristone, but would sharply restrict access to medication abortion nationwide and eliminate telemedicine abortion. The decision in Alliance for Hippocratic Medicine v. FDA remains on hold until final review by the U.S. Supreme Court.
“While the court has acknowledged that mifepristone—both brand and generic versions—can stay on the market, they are insisting we should roll back the clock to 2000 and put the medication under lock and key,” said Kirsten Moore, director of Expanding Medication Abortion Access Project (EMAA Project). “The extremist judges ignored the FDA, our basic rights, and more than 20 years of scientific evidence showing mifepristone is safe and effective, rolling back decades of advancement in the standard of care. This is a dangerous precedent for FDA’s scientific review authority.”
Mifepristone has been safely used by over 5 million women in the United States over the last 23 years, and today is used in more than half of all abortions in the U.S.
“This ruling ignores decades of evidence, instead prioritizing political ideology and political extremism,” said Dana Northcraft, founding director of Reproductive Health Initiative for Telehealth Equity & Solutions (RHITES). “True health equity includes telehealth access to medication abortion care so that people can access care without barriers, no matter where they live.”
“If today’s ruling from the Fifth Circuit goes into effect, it will have far-reaching consequences for patients and providers and roll back decades of scientific progress in how medication abortion care is provided,” said Dr. Ushma Upadhyay of Advancing New Standards in Reproductive Health (ANSIRH). “The research is clear that telehealth for medication abortion is as safe and effective as in-person care, with one in 10 abortions provided via telehealth. This ruling is disconnected from what the science tells us and not rooted in any evidence.”
The three-judge panel consisted of two anti-abortion Trump appointees: James Ho and Cory Wilson. The third was a George W. Bush nominee Jennifer Elrod. During oral arguments in May, these three judges exhibited extreme bias against the attorneys defending the FDA.
“It is absolutely infuriating that we have judges overruling medical experts and patient and doctor experience to impose outdated restrictions on mifepristone that fly in the face of medical science,” said Sen. Patty Murray (D-Wash.). “This has nothing to do with facts or science—it’s about ideology and controlling women’s bodies, plain and simple.”
We are outraged that the Fifth Circuit Court of Appeals wants to reinstate medically unnecessary restrictions on access to mifepristone, a safe and effective medication used in medication abortion care.Lupe M. Rodriguez, National Latina Institute for Reproductive Justice
In a 96-page decision, the Fifth Circuit judges ruled that the plaintiffs had waited too long to challenge the original approval of mifepristone in 2000 but were timely in their challenges to later approval modifications in 2016 and 2021. The court ruled the FDA acted improperly in this later modification in several regards, including allowing the use of mifepristone through 10 weeks of pregnancy (from seven weeks approved in 2000), lowering the recommended dosage to decrease side effects, allowing nurses and midwives to administer mifepristone, decreasing the number of appointments required to prescribe the medication from three to one, allowing the medication to be prescribed by telemedicine and mail, and allowing certified pharmacies to dispense mifepristone.
The court dismissed the plaintiff’s challenge to a 2019 FDA decision to approve a generic version of mifepristone produced by GenBioPro.
“We are outraged that the Fifth Circuit Court of Appeals wants to reinstate medically unnecessary restrictions on access to mifepristone, a safe and effective medication used in medication abortion care,” said Lupe M. Rodriguez, executive director of National Latina Institute for Reproductive Justice. “This decision is wrong and if it goes into effect, puts politics and lies about mifepristone over the health and well-being of people who need abortion care.”
Timeline: Alliance for Hippocratic Medicine v. FDA
This case was never about science. It’s about controlling women’s bodies and ripping away the fundamental right to privacy—the right for a woman to make medical decisions about her own body.Sen. Ron Wyden (D-Ore.)
The case began last November when a group of anti-abortion doctors and a dentist filed a lawsuit challenging the FDA’s approval of mifepristone in 2000.
Five days later, on emergency appeal, the Fifth Circuit Court of Appeals issued a preliminary injunction allowing mifepristone to remain on the market but severely restricted access while the case was on appeal. The Department of Justice filed an emergency appeal to the Supreme Court.
In a shadow docket ruling late on April 21, the Supreme Court blocked the Fifth Circuit injunction from taking effect, allowing mifepristone to remain on the market under current rules until a final decision.
What They’re Saying
Long-time advocate for mifepristone, Sen. Ron Wyden (D-Ore.), condemned the ruling.
“The Fifth Circuit made it clear again with its shameful decision today that it is willing to do the bidding of extremists and insert itself into women’s private lives,” said Wyden. “Any effort to restrict access to safe and effective abortion medication is nothing more than a political ploy to control women’s bodies.
“The science is clear and a wealth of evidence demonstrates the drug’s safety and efficacy, which is why the FDA approved it more than 20 years ago,” he continued. “In fact, mifepristone has fewer complications than Tylenol. But this case was never about science. It’s about controlling women’s bodies and ripping away the fundamental right to privacy—the right for a woman to make medical decisions about her own body.”
Last February, Wyden urged the Biden administration to ignore Judge Kacsmaryk’s decision in the case.
Several reproductive justice advocates spoke about the negative impact of the decision on marginalized communities.
“If the U.S. Supreme Court ultimately reinstates the baseless restrictions on medication abortion, it will intensify the already devastating impact on historically disenfranchised and oppressed people in communities needing abortion care,” said Oriaku Njoku, executive director of National Network of Abortion Funds.
Morgan Hopkins, president of All* Above All, said the ruling “would have a devastating impact and the harm will fall hardest on people working to make ends meet, especially people of color.”
The Future of Medication Abortion Access
The Department of Justice will likely appeal the case to the U.S. Supreme Court.
“The fate of women’s access to this lifesaving drug is now back in the hands of the Supreme Court – a terrifying thought for those of us who don’t trust the right-wing justices who overturned Roe and who claimed abortion is an issue to be left to the states,” said Sen. Wyden.
The Fifth Circuit decision has no impact on access to misoprostol, which is a safe and effective alternative way to end a pregnancy.
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