U.S. Capitol viewed through the columns of the U.S. Supreme Court in Washington, D.C. / Credit: Shutterstock
Washington, D.C. Newsroom, Nov 21, 2023 / 16:30 pm (CNA).
Over 100 members of Congress are urging the Supreme Court to stop more than half of U.S. abortions by ordering the FDA to revoke its abortion pill approval.
The lawmakers are arguing that the FDA’s approval process for the abortion drug had many “irregularities” and the decision to approve them has “endangered women and girls.”
Seventeen senators and 92 representatives, led by Sen. Cindy Hyde-Smith, R-Mississippi, and Rep. August Pfluger, R-Texas, signed onto an amicus brief written by Americans United for Life and sent it to the Supreme Court on Nov. 15.
The lawmakers argued in their brief that the Supreme Court should invalidate the FDA’s 2000 approval of the abortion drug mifepristone, the pill that now accounts for over half of all U.S. abortions. This would be a ruling in favor of the pro-life groups in the ongoing abortion case Alliance for Hippocratic Medicine v. Food and Drug Administration (AHM v. FDA).
The case revolves around mifepristone, a widely used drug that is primarily manufactured by Danco Laboratories. It works by cutting off the flow of nutrients necessary for an unborn baby to continue growing, essentially starving the child to death in the womb. A second drug, misoprostol, is then typically ingested to induce contractions that expel the dead unborn child.
In their brief, the lawmakers argue that in approving mifepristone in 2000 the FDA “acted arbitrarily and capriciously” and violated several federal laws including the Administrative Procedure Act; Federal Food, Drug, and Cosmetic Act; and Pediatric Research Equity Act.
The brief also states that the FDA “misclassified pregnancy as a ‘life-threatening illness’” and erroneously claimed that chemical abortions provide a meaningful therapeutic benefit.
Finally, the brief says that the FDA “subverted its obligations” to ensure new drugs are safe and effective, most especially for pediatric use and use by young patients.
“As pro-life elected representatives, Amici [signees] are committed to protecting women and girls from the harms of the abortion industry,” the brief reads. “By approving and then deregulating chemical abortion drugs, the FDA failed to follow Congress’ statutorily prescribed drug approval process and subverted Congress’ critical public policy interests in upholding patient welfare.”
What has happened so far?
The most recent ruling in AHM v. FDA was made by the federal Fifth Circuit Court of Appeals, which in August invalidated the FDA’s post-2016 rule changes to mifepristone.
The Fifth Circuit said in its ruling that the FDA failed to “consider the cumulative effect of removing several important safeguards” and “to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
This means that pre-2016 restrictions on abortion drugs such as a ban on mailing them or administering via telemedicine, without an in-person doctor’s visit, will be reimposed.
Despite the appellate court ruling, the abortion pill is still available under the post-2016 rules as the lawsuit awaits action from the U.S. Supreme Court. This is because of an April decision by the Supreme Court to keep mifepristone available under the post-2016 regulations for the duration of the litigation process.
In September, the Biden administration, through the Department of Justice, appealed the Fifth Circuit’s ruling to the Supreme Court. The administration argued in its appeal that the Fifth Circuit failed to demonstrate the FDA’s scientific and research errors and that the ruling has “especially disruptive implications for the pharmaceutical industry and those who depend upon the drugs it supplies.”
Danco Laboratories also filed an appeal to the Supreme Court.
In October, the Alliance Defending Freedom (ADF), the law firm representing the pro-life groups in this case, filed what’s called a “conditional cross-petition.” In its petition, ADF argued that if the Supreme Court takes up the Biden administration and Danco’s appeals, they should invalidate the FDA’s 2000 mifepristone approval as well as its post-2016 changes.
According to ADF’s petition, the FDA “disregarded law, science, and safety in pursuit of a political end” and the “Fifth Circuit erred in rejecting the challenges to FDA’s approvals of chemical abortions.”
The amicus brief sent by the members of Congress is in support of ADF’s conditional cross-petition.
The lawmakers’ brief states that “since the FDA’s lawless approval of mifepristone subverts patient safeguards and contravenes federal laws, Amici urge the court to grant Alliance for Hippocratic Medicine’s conditional cross-petition if the court grants the Food and Drug Administration and/or Danco’s petitions for a writ of certiorari.”
One of the signees, Rep. Mark Green, a Tennessee Republican and a doctor, said in a Nov. 16 statement: “To this day, we still have no idea how mifepristone affects adolescent girls because the FDA didn’t bother to run trials. Coupled with the Biden administration’s policy allowing mifepristone by mail, this makes for a dangerous situation for women.”
“I urge the Supreme Court to consider this case carefully,” Green said. “Abortion is wrong, period, but this chemical abortion drug has a greater risk for women’s health than even surgical abortions. I am appalled at the FDA for putting politics before its mission — protecting Americans.”
The Supreme Court has not yet signaled whether or not it will take up the Biden administration or Danco’s appeals.
The U.S. Conference of Catholic Bishops also signed onto the amicus brief urging the Supreme Court to revoke the FDA’s 2000 abortion pill approval, according to a statement by Pfluger. Other organizations that have also signed onto the brief according to Pfluger include CatholicVote, Susan B. Anthony Pro-Life America, March for Life, Students for Life of America, National Right to Life, and Live Action.