By L.A. Williams
Christian Action League
March 29, 2024
In what some media outlets called the most significant abortion case since Roe v. Wade was overturned in 2022, the U.S. Supreme Court on Tuesday heard arguments regarding mifepristone, one of two medications used in chemical abortions, and the FDA’s removal of safeguards surrounding the drug.
“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions. We urge the Supreme Court to do the same,” said Erin Hawley, the lawyer for Alliance for Hippocratic Medicine. “The FDA has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen. Like any federal agency, the FDA must rationally explain its decisions. Yet its removal of common-sense safeguards—like a doctor’s visit before women are prescribed chemical abortion drugs—does not reflect scientific judgment but rather a politically driven decision to push a dangerous drug regimen.”
The case, Food & Drug Administration v. Alliance for Hippocratic Medicine, centered on three issues: whether the respondents have standing to challenge the FDA’s actions; whether those actions were arbitrary and capricious; and whether the district court properly granted preliminary relief. While many observers reported that justices seemed likely to rule in the FDA’s favor, the outcome of the case is not expected to be released until June or July.
“Our hope and prayer is that the High Court takes an open-minded approach and looks at the complete history of how this drug was unleashed and the damage it has caused, especially since it has become available without an in-person doctor’s appointment,” said the Rev. Mark Creech, executive director of the Christian Action League.
Initially approved for use in the United States in 2000, mifepristone blocks the hormone progesterone, effectively killing an unborn baby, which is then expelled with the help of a second drug called misoprostol. Women were required to undergo three doctor visits before receiving the drug, which was given only during the first seven weeks of gestation.
But in 2016, the FDA dropped those requirements, allowing it to be given up to 10 weeks with just one in-person doctor visit. The agency also no longer required those prescribing the drug to report non-fatal complications. The changes raised concern among doctors, some of whom filed a citizen petition in 2019 questioning the FDA’s move.
In April 2021, eight months before denying the petition and in the midst of the Covid pandemic, the FDA announced a temporary removal of the in-person dispensing requirement. By year’s end, that change would become permanent, opening the door for chemical abortions by mail and telemedicine.
Alliance Defending Freedom attorneys filed suit in 2022, challenging the FDA’s actions and representing medical associations and individual doctors who had witnessed the harm done to women by the drug. In April of last year, a federal district court halted the FDA’s actions on the drug, and days later the U.S. Court of Appeals for the 5th Circuit kept part of that ruling in place restoring some safety protocols while the lawsuit proceeded.
In hearing the case on Tuesday, Supreme Court justices raised several questions regarding whether the doctors had legal standing to sue. Solicitor General Elizabeth Prelogar, who represented the FDA, said the court should dismiss the case and that respondents don’t “come within 100 miles” of having standing. But Hawley pointed out that because chemical abortions are more likely than surgical ones to land women in the emergency room, ER doctors are often left to finish incomplete abortions, which is a violation of their conscience.
Women who take mifepristone can face severe bleeding and infections requiring emergency medical treatment, surgeries, blood transfusions, and hysterectomies, making the medication too risky to take at home alone.
Nonetheless, winning the case against the FDA and Danco, which makes the brand name version of the pill, Mifeprex, will be an uphill battle. The pharmaceutical industry has warned that if judges second-guess the FDA’s approval process, it could open the door to cases regarding vaccines or other controversial drugs.
“At one point in the arguments, Justice Samuel Alito asked the Danco attorney if the FDA is infallible, which is really the heart of the issue,” Creech said. “How can this agency be allowed to arbitrarily do away with safety rules? How can they make a rule that doctors don’t need to report non-fatal complications related to a drug and then use the lack of reported complications as a basis for loosening restrictions?”
“Sadly, I fear that rather than getting to the bottom of the issue, the case may be tossed out based on fear of what kind of precedent it would set.”