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Texas judge’s ruling suspends FDA approval of abortion pill mifepristone, jeopardizing availability nationwide

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Boxes of the drug mifepristone line a shelf at the West Alabama Women's Center in Tuscaloosa, Ala.Mifepristone is frequently used in combination with misoprostol to end pregnancies.

Allen G. Breed, File/AP

  • Texas Judge Matthew Kacsmaryk issued a ruling Friday that jeopardizes the availability of a key abortion drug.
  • An antiabortion legal group had sought to revoke or suspend the FDA’s approval of the drug mifepristone.
  • Medication abortions have grown in popularity and now account for more than half of all abortions.

A federal judge sided with conservative, anti-abortion activists on Friday and issued an unprecedented ruling that seeks to block the distribution of a key abortion drug, mifepristone.

In the ruling, Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump, imposed a stay on the Food & Drug Administration’s approval of the drug, arguing that it was unlawful. Anti-abortion activists have argued the FDA did not properly consider the risks to women, an assertion disputed by every leading medical organization, which have noted that an unwanted pregnancy is far more likely to result in injury or death.

To justify the decision, the ruling points to, among other things, research purporting to show that 14% of women who took the abortion drug were not properly informed about its side effects. The cited study, however, was of women’s experiences as told in blog posts on one particular website, which the author analyzed using “relational dialectics theory.”

The ruling was expected by most observers of the court, with Judge Kacsymaryk having been sought out by right-wing plaintiffs due to his own conservative credentials, and does not take effect immediately, providing the Biden administration a week to appeal the decision with a higher court.

A coalition of medical groups and doctors opposing abortion, led by the Alliance Defending Freedom, filed a lawsuit late last year asking his court in Amarillo, Texas, to suspend or withdraw the FDA’s approval of mifepristone. The groups called the drug “dangerous” and argued that the FDA never should have allowed it in 2000. 

In response, the US government has argued that overwhelming evidence and numerous studies have shown mifepristone to be safe and effective for ending a pregnancy.

The litigation has sparked concern and outrage from reproductive rights activists. Revoking the FDA’s approval of mifepristone could immediately upend abortion access for countless women across the country. 

During a March 15th hearing, even the Alliance Defending Freedom acknowledged the significant and unprecedented nature of their demand.

The attorney representing Alliance Defending Freedom, Erik Baptist, said he could think of no other case in which a court has revoked FDA approval of a drug that has been on the market for over 20 years.

The abortion medications mifepristone and misoprostol have been the subject of heightened scrutiny and controversy since last June when the Supreme Court overturned Roe v. Wade. The decision prompted a wave of new abortion restrictions in states across the country. Some conservative lawmakers and activists have focused on limiting access to the pills, while their liberal counterparts have attempted to expand access.

The medication mifepristone typically works as part of a two-medication regimen to terminate pregnancies. Mifepristone blocks the hormone progesterone, which is necessary to sustain a pregnancy, and then misoprostol is typically taken 24 to 48 hours later to induce contractions. The drug combination is effective through 10 weeks of gestation, according to the FDA.

Even before Roe v. Wade’s overturning, medication abortions had been growing increasingly common in recent years — particularly during the pandemic when patients couldn’t visit clinics in person. Recent research now indicates that more than half of all abortions in the US are done by medication, rather than surgery.

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