Judge could prompt FDA reversal of abortion pill mifepristone approval

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A case before a federal judge in Texas could have dramatic effects on abortion access nationwide as anti-abortion groups target the decades-long government approval of a key abortion drug.

A decision is expected by Feb. 24 at the earliest in a case attempting to reverse the FDA’s approval of mifepristone, a medication that can be used with another drug called misoprostol to end a pregnancy. A ruling was previously expected by Friday at the earliest, but a judge issued an order extending the briefing process.

A coalition led by the conservative legal advocacy organization Alliance Defending Freedom filed the lawsuit Nov. 18 in federal court in Amarillo, Texas, arguing the drug comes with medical risks and should be pulled from the market. 

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There could be a nationwide ban on abortion pills 

If the judge rules in favor of the anti-abortion coalition, abortion access advocates say it could effectively ban mifepristone nationwide, creating severe consequences on people’s ability to access critical abortion and miscarriage care, especially after the overturning of Roe v. Wade.

The decision “will unleash a public health crisis by removing health care options for millions of people,” said Jenny Ma, senior counsel at the Center for Reproductive Rights.

A ruling in the anti-abortion groups’ favor could mean healthcare providers will be barred from prescribing mifepristone even in states where abortion is legal. In-clinic, procedural abortion care would not be affected by the ruling.

“I think people find it shocking when they learn this will affect the abortion access of everyone across the country even in the bluest of blue states,” said Lorie Chaiten, senior staff attorney at the ACLU’s Reproductive Freedom Project.

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What is mifepristone and medication abortion?

Even before the U.S. Supreme Court struck down Roe v. Wade in June, medication abortion accounted for more than half of all abortions in the United States, according to the Guttmacher Institute, a research and policy organization that supports abortion rights.

The FDA approved mifepristone for medication abortion in 2000. The U.S. Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone a safe and effective abortion medication and component of treatment and management for early pregnancy loss or miscarriage.

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Julie Blake, senior counsel at Alliance Defending Freedom, said the group is “asking the court to order the FDA to put politics aside…and protect women and girls by removing these drugs from the market or, at a minimum, by restoring important safeguards on their use.”

“When it comes to chemical abortion drugs, the FDA has completely failed its statutory duties to protect women and girls,” Blake said.

Alliance Defending Freedom is considered an anti-LGBTQ hate group by the Southern Poverty Law Center. ADF told USA TODAY it “categorically rejects” this classification, calling it a “deliberate mischaracterization of our work.”

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Anti-abortion activists take part in the 49th annual March for Life, on Jan. 21, 2022, in Washington, D.C.

Conservative judge to rule on lawsuit

Legal experts have ridiculed the lawsuit as without legal or scientific standing.

“In a normal world, this lawsuit would be dismissed and laughed out of court,” Chaiten said.

But abortion access advocates are still sounding alarms over the case because it was filed in Amarillo, Texas, where the only judge is U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump with a history of conservative rulings.

“This is one single judge in Texas, a state that has already banned abortion, deciding the medication abortion access of every single person across the country,” Ma said.

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What would happen next?

Kacsmaryk could grant an emergency injunction forcing the FDA to withdraw its approval of mifepristone and pull the drug off the market nationwide. While the FDA could choose to restart the approval process, this may take years.

The case would likely be appealed, landing it in the right-leaning Fifth Circuit Court of Appeals, “where we have similar concerns to the concerns about Judge Kacsmaryk,” Chaiten said.

Eventually, the case may arrive before the U.S. Supreme Court.

Chaiten said she knows of no other case where a federal judge has ordered the FDA to remove approval of a drug. As a result, she said this case could have “far-reaching effects” on other drugs as well.

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Abortion rights activists demonstrate on Jun 24, 2022, in New York City.

Providers rush to consider misoprostol-only options

Ashley Brink, clinic director at the abortion clinic Trust Women Kansas in Wichita, said her team has spent weeks holding staff trainings and updating policies in preparation for the ruling. She said the clinic would pivot to a misoprostol-only protocol for medication abortions, which she called “a safe and effective alternative” to using both mifepristone and misoprostol.

While misoprostol has been used on its own for years for abortions around the world, studies show it is less effective than the two-step regimen.

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People march down State Street to the Capitol during the National Women's March marking 50th anniversary of the Roe v. Wade decision, in Madison on Sunday, Jan. 22, 2023.

Brink said her clinic has already been overwhelmed by a surge in out-of-state patients since the overturn of Roe. Now, as many patients may lose access to medication abortion, she worries the long lines and delays will only worsen.

“We know continued barriers to abortion access such as this will impact communities of color, rural communities and people living in poverty or with low incomes the hardest,” she said.

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Hundreds expected to protest in Amarillo

Hundreds of abortion rights supporters are expected to protest Saturday afternoon outside the federal courthouse in Amarillo, according to the Women’s March.

“This isn’t about what the overwhelming majority of Americans want; it’s about a small group of people who want control over women’s freedom to choose,” Rachel Carmona, executive director of Women’s March, said in a statement.

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medical abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Other legal battles continue over medication abortion

Other ongoing lawsuits also center abortion pills.

The drug company GenBioPro, which makes generic mifepristone, sued officials in West Virginia, arguing the state’s abortion ban contradicts FDA approval of mifepristone. An obstetrician-gynecologist also sued officials in North Carolina on similar grounds.

Meanwhile, the FDA ruled last month that some pharmacies that undergo a certification process would soon be able to dispense mifepristone in states where abortion is legal. 

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Demonstrators take part in the annual National Women's March in Washington, D.C., on Jan. 22, 2023, marking the 50th anniversary of the 1973 Supreme Court Roe v. Wade decision legalizing abortion. The Supreme Court on June 24, 2022, struck down the Roe v. Wade decision which legalized abortion, ending five decades of constitutional protections.

Contact Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.

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