Texas Judge Considers Ban on Abortion Pill
A Texas judge on Wednesday, March 15, held the first hearing in a lawsuit seeking to overturn federal approval of a common abortion pill nationwide, including in states where abortion is protected.
The lawsuit, filed by the Alliance for Hippocratic Medicine and other anti-abortion groups against the U.S. Food and Drug Administration (FDA), challenges the 23-year-old regulatory approval of mifepristone, one of two drugs used in medication abortions. A decision in the groups' favor could dramatically alter access to abortion medication, which is used in more than 50 percent of all pregnancy terminations in the United States.
Arguments were heard by U.S. District Judge Matthew Kacsmaryk, a conservative appointee of former President Donald Trump whose anti-abortion views are explicit and well-documented.
About the lawsuit
The plaintiffs, represented by the conservative Christian legal advocacy group Alliance Defending Freedom, are pursuing a ruling that would force the FDA to revoke approval of mifepristone. The plaintiffs are alleging that the government agency did not sufficiently evaluate the drug's safety before approval and shouldn't have made it accessible via telehealth during COVID-19.
"We are not seeking a nationwide abortion ban. We're focusing on one means of abortion here because it's dangerous," Baptist said in the March 14 news report.
However, the Biden administration, responding to the suit in a recent court filing, has maintained that the "FDA extensively reviewed the scientific evidence and determined that the benefits of mifepristone outweigh any risks" and "public interest would be dramatically harmed" if the drug is banned.
The potential consequences of the lawsuit
If Kacsmaryk grants an injunction, it would be the first time a judge ordered the removal of a drug from the market despite opposition from the FDA. In a court filing, the Justice Department said the lawsuit could upend the country's process for regulating drugs.
"The injunction request is extraordinary and unprecedented," the Justice Department wrote. "Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA's safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market."
In addition, the ruling would impact access to medical abortion for about 64.5 million women of reproductive age, according to a recent analysis from NARAL Pro-Choice America.
Major medical organizations, including the American College of Obstetricians and Gynecologists and the American Medical Association, have denounced the lawsuit, writing in a court brief, "making mifepristone unavailable nationwide—even in states where abortion remains legal—will impose a severe, almost unimaginable cost on pregnant people throughout the United States."
When the ruling is expected
It was unclear whether Kacsmaryk would issue a decision at the end of Wednesday's session, a hearing he tried to keep secret, citing "a barrage of death threats and protesters and the rest" and a desire to avoid a "circus-like atmosphere," according to a court transcript.
If Kacsmaryk grants the injunction, federal attorneys are expected to appeal the ruling and seek an emergency stay or pause to prevent it from taking effect while the lawsuit plays out. If Kacsmaryk rejects the request for an injunction, the plaintiffs, too, can pursue the immediate intervention of a higher court.