A federal judge in Texas considered arguments Wednesday in a potentially life-saving abortion case that challenges the U.S. Food and Drug Administration’s approval of the abortion drug mifepristone.
During the four-hour hearing, U.S. District Judge Matthew Kacsmaryk “seemed open” to a group of doctors’ argument that the FDA did not properly study the safety of the abortion drug before approving and later expanding its use, the Washington Post reports.
The abortion drug mifepristone is used for more than half of all abortions in the U.S., killing hundreds of thousands of unborn babies every year, according to the Guttmacher Institute.
The lawsuit, filed by doctors with the Alliance for Hippocratic Medicine, challenges the FDA’s approval of the drug in 2000 and later expansions under the Obama and Biden administrations. A ruling in their favor potentially could save hundreds of thousands of unborn babies’ lives.
Represented by the Alliance Defending Freedom, the doctors pointed to evidence that the FDA skirted the review process and ignored safety problems.
The case has abortion activists alarmed, with many predicting that Kacsmaryk, who was appointed by President Donald Trump, could block approval of the drug and make it unavailable nation-wide. Over the weekend, Kacsmaryk said the court has received numerous threats, including death threats in response to the case.
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On Wednesday, lawyers with the U.S. Department of Justice argued on behalf of the FDA that there is massive evidence showing the abortion pill is safe, even when taken without the direct supervision of a doctor, according to the newspaper. The Biden administration recently began allowing the abortion pill to be sold through the mail or in a pharmacy without direct medical supervision.
The Justice Department argued that the doctors’ lawsuit also “fails to acknowledge that the alternatives to mifepristone — surgical abortion or continued pregnancy — also have rates of complications, with childbirth’s being substantially higher than mifepristone’s.”
But Alliance Defending Freedom attorney Erik Baptist said the FDA has been “stonewalling” challenges and requests for information about the evidence and process it used to approve the abortion drug for decades, the AP reports.
When Kacsmaryk asked if Baptist could name any other examples of a court blocking an FDA-approved drug, Baptist said he could not. However, the lawyer pointed to the U.S. Supreme Court Dobbs v. Jackson ruling about abortion, saying revoking approval of the abortion drug would “restore proper policing power to the states,” according to the report.
“Today, we asked the court to put the health and wellbeing 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 Defending Freedom senior counsel Erik Baptist after the hearing. “The FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”
“As we stated in court, the FDA never had the authority to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer,” Baptist continued.
The judge said he would rule on the case soon, the Washington Post reports.
Lawyers with Alliance Defending Freedom asked for a preliminary injunction that requires the FDA to revoke or suspend approval of mifepristone as an abortion drug. If Kacsmaryk rules in the doctors’ favor, the federal government will appeal.
According to the doctors’ lawsuit, one of the problems is the FDA classified pregnancy as a “serious or life-threatening disease” in order to move the abortion drug through its accelerated approval program. Although pregnancy complications can be serious or life-threatening, the doctors said pregnancy itself is not.
“The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be more stark,” Baptist told the judge, the AP reports.
Here’s more from the report:
But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone, including requiring physicians to be certified before prescribing it.
First approved under the Clinton administration, mifepristone is used to abort unborn babies up to about 10 weeks of pregnancy – although some abortionists use it later. It works by blocking the hormone progesterone and basically starving the unborn baby to death. Typically, abortion groups also prescribe a second drug, misoprostol, to induce labor and expel the baby’s body.
Since the overturning of Roe v. Wade, the pro-abortion movement has been pushing abortion drugs even more heavily, and some groups send the drugs to women in pro-life states illegally.
Meanwhile, the Biden administration has been trying to expand the life-destroying drugs even further, first by allowing abortion drugs to be sold through the mail without any direct medical supervision, and, more recently, by allowing pharmacies like Walgreens, CVS and RiteAid to sell them.
In California, public colleges and universities also are required to provide abortion drugs for free on campus, and other Democrat-run states are considering similar mandates.
But a ruling by the federal judge potentially could change that.
Along with millions of unborn babies’ deaths, the FDA has linked mifepristone to at least 28 women’s deaths and 4,000 serious complications. However, under President Barack Obama, the FDA stopped requiring that non-fatal complications from mifepristone be reported. So the numbers almost certainly are much higher.
Studies indicate the risks of the abortion drug are more common than what abortion activists often claim, with as many as one in 17 women requiring hospital treatment. A recent study by the Charlotte Lozier Institute found that the rate of abortion-related emergency room visits by women taking the abortion drug increased more than 500 percent between 2002 and 2015.
Another new study from the University of Toronto, “Short-Term Adverse Outcomes After Mifepristone–Misoprostol Versus Procedural Induced Abortion,” published in the Annals of Internal Medicine, found that one in ten women who took the abortion pill had to go to the emergency room, according to Pregnancy Help News.