A federal judge in Texas heard arguments but did not rule Wednesday on whether to block the Food and Drug Administration’s approval of a pregnancy-termination drug, a case viewed as the most significant legal battleground on abortion since the fall of Roe v. Wade.
Alliance Defending Freedom attorneys urged U.S. District Judge Matthew Kacsmaryk to withdraw or suspend the FDA’s 2020 decision on mifepristone, arguing that the agency fast-tracked the drug for political reasons without adequately studying its safety when used to end pregnancies.
“Today, we asked the court to put the health and well-being of women and girls first by undoing the harms that FDA has caused by illegally approving dangerous chemical abortion drugs and removing necessary protections,” said Alliance senior counsel Erik Baptist, who represented several pro-life medical organizations and doctors, after the hearing.
On the other side were attorneys for the Justice Department and Danco Laboratories, the maker of mifepristone, the first drug in the two-pill regimen that has become the nation’s most common method of pregnancy termination.
Judge Kacsmaryk concluded the hearing without ruling from the bench, reportedly saying he would issue a decision as soon as possible. Each side received two hours to make their arguments, with time for rebuttal. No electronics were allowed in the courtroom.
Outside the courthouse in Amarillo, Texas, a band of pro-choice protesters held signs with messages such as, “Defend Medication Abortion.” A rally organized by the Women’s March was scheduled for Wednesday evening.
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“We won’t let them take away our rights,” said the Women’s March in a statement. “We’re going to shine a light on these bad actors. All eyes on Amarillo.”
Heightening the drama were accusations that Judge Kacsmaryk, a Trump appointee, tried to “hide” the hearing by delaying placing the notice on the docket to minimize harassment and threats directed at the court. Word leaked out anyway.
The pro-choice group UltraViolet sent out a mobile billboard to loop downtown Amarillo with the message, “A Majority of Americans Support Abortion Access/Judge Kacsmaryk, You Can’t Hide From Us.”
“Judge Kacsmaryk and the ADF were already making a mockery of our nation’s judicial system with this case challenging a pill that has been safely used publicly available for more than two decades — but the latest news that they are trying to do so out of the public eye is a new low even for them,” said UltraViolet co-founder and Executive Director Shaunna Thomas.
One point made clear under questioning is that a court has never removed an FDA-approved drug from use after such a long period of time. Mr. Baptist blamed the FDA for “stonewalling,” according to The Associated Press, saying his group had petitioned the agency to pull its approval in 2002 and 2019.
The alliance has also argued that the FDA reviewed the drug under an accelerated program for “serious or life-threatening diseases,” a protocol launched in the early 1990s to hasten access to early HIV drugs, and later cancer treatments.
The lawsuit declared that “pregnancy is not an illness,” meaning that the FDA should not have approved mifepristone under the accelerated protocol. The FDA has countered that its regulations describe pregnancy as a “medical condition” that can put the patient’s health or life at risk.
Chuck Donovan, president of the pro-life Charlotte Lozier Institute, said Wednesday that major international studies show that abortion pills carry four times the risk of surgical abortions, and that emergency room visits have spiked over 500%.
Ingrid Skop, a Texas board-certified obstetrician-gynecologist and Charlotte Lozier medical director, said that the FDA “has ditched common sense, ignored its own rules and bypassed important safeguards when approving the abortion pill.”
“Does this powerful drug impact adolescent development? Future fertility? No one knows, because the FDA never bothered to perform focused studies on girls under 18,” she said in a Wednesday statement.
Supporters argued that the U.S. abortion-pill regimen has been used safely for 23 years and that serious complications are rare.
“Medication abortion is routine medical care. Full stop,” tweeted Rep. Ayanna Pressley, Massachusetts Democrat.
The abortion pill has become the fallback in states with tight abortion restrictions after the Supreme Court overturned Roe last June, realigning the debate from clinics to drugstores and post offices.
The FDA made permanent in December 2021 its pandemic-era rules allowing the abortion pills to be prescribed via telehealth and mailed to patients to terminate pregnancies through 10 weeks’ gestation. In January, the FDA said it would allow certified pharmacies to dispense the pills, including by mail.
An injunction on mifepristone would likely mean that doctors would switch to a single-drug regimen using only misoprostol, the other pill in the two-drug protocol. The World Health Organization and others say misoprostol alone is only slightly less effective and often used in countries where mifepristone is not available.
Women using the two-pill regimen take mifepristone first, which blocks progesterone, “thereby preventing an existing pregnancy from progressing,” said the Kaiser Family Foundation.
“Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage,” said the foundation.
• The Associated Press contributed to this report.
• Valerie Richardson can be reached at vrichardson@washingtontimes.com.
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