Federal judge revokes FDA approval of key abortion drug nationwide

A ruling by a federal judge in Texas Friday revoked the decadeslong government approval of mifepristone, a key abortion drug, potentially decimating access to medication abortion nationwide. The ruling won't immediately go into effect, as the federal government has seven days to appeal.

The ruling means healthcare providers could be barred from prescribing mifepristone, even in stateslike Oregon were abortion is legal. In-clinic, procedural abortion care will not be affected by the ruling.

A coalition led by the conservative legal advocacy organization Alliance Defending Freedom in November filed a federal lawsuit in Amarillo, Texas, arguing the drug comes with medical risks and should be pulled from the market. U.S. District Judge Matthew Kacsmaryk in Texas sided with anti-abortion groups in the case.

Abortion access advocates said the ruling could have severe consequences on people’s ability to access abortion and miscarriage care, especially after the overturning of Roe v. Wade.

Gov. Tina Kotek in a statement criticized the ruling.

“This is a shameful, dangerous ruling that will prevent patients across the country from accessing safe, effective medication. As we sort out the impact of this ruling, hear me loud and clear: abortion is still accessible and legal in Oregon," she said in the statement.

Oregon state law protects abortion access and has none of the significant restrictions on abortions that are seen in other states, such as waiting periods, mandatory ultrasounds or parental involvement.

Oregon's law: How the Supreme Court abortion ruling impacts Oregon

What does this ruling mean?

The ruling could affect medication abortion access for about 64.5 million women of reproductive age nationwide, according to an analysis released Feb. 10 by NARAL Pro-Choice America.

Lorie Chaiten, senior staff attorney at the ACLU's Reproductive Freedom Project, said the ruling could "create an unprecedented disruption to healthcare access."

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.

What is mifepristone and medication abortion?

Even before the U.S. Supreme Court last year struck down the constitutional right to abortion granted by Roe v. Wade, 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 drug is typically taken in a two-step regimen along with another medication called misoprostol. 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 a component of treatment and management for early pregnancy loss or miscarriage.

What could happen next?

While the FDA could choose to restart the approval process, this may take years, Chaiten said.

The case would likely be appealed, landing it in the right-leaning Fifth Circuit Court of Appeals. If the case is appealed again in federal circuit court, it may arrive before the U.S. Supreme Court.

Filing lawsuit in Amarillo part of legal strategy

Several legal experts said it was no accident the complaint was filed in Amarillo, Texas, where the only judge is Kacsmaryk, an appointee of former President Donald Trump who has 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.

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

Providers rush to consider misoprostol-only options

Providers nationwide are rushing to shift to misoprostol-only protocols for medication abortions, and clinics have already begun ordering more misoprostol supplies, said Ashley Brink, clinic director at Trust Women Kansas in Wichita.

She said misoprostol-only methods have been used globally for years as "a safe and effective alternative" to using both mifepristone and misoprostol.

Studies show misoprostol-only methods are less effective than the two-step regimen.

Ruling to hit marginalized communities hardest

Low-income and people of color could be disproportionately impacted by the reversal, experts say. A Centers for Disease Control and Prevention analysis showed about 67% of U.S. abortion seekers were non-white.

Terri-Ann Thompson, senior researcher at Ibis Reproductive Health, said the reversal disregards patient preference, cost and travel burdens of marginalized communities.

"One of the reasons, among many, that people actually choose a medication abortion is because it is the less costly option of the abortion options available," she said. "It's a racial justice issue and economic disadvantage is at the root."

Lupe Rodríguez, executive director at the National Latina Institute for Reproductive Justice, said many immigrant women are accustomed to medication abortion and prefer it.

The Statesman Journal contributed to this article. Contact Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.

This article originally appeared on USA TODAY: Judge revokes FDA approval of key abortion drug nationwide