District court supports abortion pill limits, pivots decision to Supreme Court

Published 12:00 pm Friday, August 18, 2023

NEW ORLEANS — As it did last year, the U.S. Supreme Court will likely again address abortion access — this time in deciding restrictions on a widely used abortion pill, mifepristone.

In 2022, the Supreme Court voted to overturn Roe v. Wade, which enshrined federal protections of women’s decision to get an abortion.

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And now, three judges in the 5th U.S. Circuit Court of Appeals in New Orleans pivoted its Aug. 16 decision to restrict the pill to the U.S. Supreme Court for review; However, if the high court does not accept the case, “Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (and Danco Laboratories),” the lower court’s decision will stand.  

The appeals court sided with plaintiffs agreeing that the Food and Drug Administration failed to properly account safety concerns when it loosened access to mifepristone in 2016.

Mifepristone, a generic for Mifiprex, together with another drug, misoprostol, is FDA-approved and is used in more than half of abortions for use up to through 10 weeks of pregnancy.

In part, the judge’s decision, if approved, would reverse a 2021 FDA decision that removed the in-person dispensing requirement and allowed mifepristone to be prescribed remotely and sent via mail as a result of the COVID-19 pandemic.

“Until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016,” the decision stated.

If approved by the Supreme Court, those conditions would include:

  • Only women whose pregnancies have a gestational age of 49 days or less are eligible.
  • Only physicians can prescribe Mifeprex.
  • All prescribing physicians must be able to assess gestational age, diagnose ectopic pregnancies, and “provide surgical intervention in cases of incomplete abortion or severe bleeding” or have arranged for another physician to provide such care.
  • Prescription must occur in person.
  • Prescribers must report any “hospitalization, transfusion or other serious event to the sponsor.

Testimony from a handful of doctors in the court case referenced patients who ultimately required surgery after taking mifepristone.

Among some doctors’ testimonies against the pill is that treating for complication from the pill is contrary to their moral beliefs.

“The FDA’s expansion of chemical abortion … harms my conscience rights because it could force me to have to surgically finish an incomplete elective chemical abortion,” one doctor testified, according to the appeals ruling. “I object to abortion because it ends a human life. My moral and ethical obligation to my patients is to promote human life and health. But the FDA’s actions may force me to end the life of a human being in the womb for no medical reason.”

Doctors in the lawsuit also argued that treating mifepristone patients imposes mental and emotional stress on non-emergency doctors, diverts time and resources from their ordinary practice, and exposes them to greater malpractice liability and increased insurance costs.

Defendants and advocates of abortion access continue to argue that the pill, overall, is safe and effective.

According to the FDA’s most updated Risk Evaluation and Mitigation Strategy medication guide, in studies conducted in the United States, between 2.9% and 4.6% of women visited the emergency room after taking mifepristone.

Previous FDA reported that from September 2002 through December 2018, more than 1,000 of the 3.7 million abortion pill usages have led to hospitalization. From September 2002 through December 2018, the FDA reported that at least 24 chemical abortion (mifepristone)- related deaths, and nearly 100 reported uses, have led to ectopic pregnancy.

“To be clear: mifepristone is an FDA-approved medication that has been proven safe and effective for women in all walks of life for over two decades. It has a safety record of over 99% — more than that of Tylenol or Viagra,” said Rachel O’Leary Carmona, executive director of Women’s March. “We implore the Supreme Court to authorize the availability of mifepristone and close the book on this illegitimate threat to reproductive rights.”

The Supreme Court, if it decides to accept the case, is expected to make a final determination on the New Orleans appeals court’s decision.

In the aftermath of Court’s decision last year to overturn Roe v. Wade, states were allowed to impose their own abortion laws. At least 14 states, a majority of them in the South, have total abortion bans in affect, with limited exceptions for medical emergencies and/or rape and incest.  

“While the (district) court did not withdraw approval entirely, if allowed to take effect, this decision would wreak havoc on access to abortion and will undermine drug development and innovation processes for other essential medications,” ACLU representatives said in a statement: “This decision has the full potential to further decimate people’s ability to get an abortion in every state. … We know this isn’t just a battle over Roe. It is an instrument in a larger battle against all of our bodily rights.”