Court Rules FDA Must Restore Safeguards on Dangerous Abortion Pill That Hurts Women

A federal appeals court issued a ruling today requiring the FDA to restore the safeguards it recently removed on the dangerous abortion pill that has killed dozens of women and injured thousands.

The 5th Circuit Court of Appeals issued a decision Wednesday in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that found the FDA must restore critical safeguards for chemical abortion drugs.

The appeals court condemned the improper FDA approval process for the drug and restored strict limits on the drug meant to protect women’s health that the Biden administration removed.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” Alliance Defending Freedom Senior Counsel Erin Hawley told LifeNews.

“The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen,” she added. “The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

By illegally approving chemical abortion drugs, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.

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Kristan Hawkins of Students for Life also applauded the decision.

“The Fifth Circuit of Appeals has acknowledged the facts & science that abortion pills hurt mothers, not just babies. The 2016 provisions requiring doctors to do the minimum to protect women from dying of these dangerous pills are back in place. This is a good start,” she said on Twitter.

The appellate court said the FDA’s faulty decision to approve the abortion drug could stand because too much time had passed since it was approved — even if that approval process was problematic.

Unfortunately the abortion drug will continue killing babies and hurting women because suspension of the drgu was denied by the Supreme Court while this lawsuit continues.

“This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016,” the court said

The 5th Circuit panel also said the FDA’s 2019 approval of a generic version of mifepristone, made by the company GenBioPro, should be left in place and “will also be available under the same conditions as Mifeprix.”

The panel of Judges Jennifer Walker Elrod, James Ho and Cory Wilson issued the ruling. Ho said in a separate opinion that while he agrees with the majority that the 2016 and 2021 changes to mifepristone’s rules must be set aside, he believes the FDA’s initial approval in 2000 violates the agency’s own rules and must also be invalidated.

The panel also said that it was not to late for the doctors challenging the FDA approval to move forward with their concerns about the moves in 2016 by the Obama administration to remove all important safety regulations on the abortion pill. Additionally, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven weeks’ gestation to 10 weeks’ gestation. The 5th Circuit’s order moved that back to seven weeks’ gestation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions.

The removal also included allowing abortion pills to be sold by mail — which further put women’s lives and health at risk.

The Appeals Court order temporarily reinstated all of those pro-life limits on the abortion drug. The Justice Department is likely to appeal the order to the Supreme Court because Joe Biden and Democrats want absolutely no limits on killing babies in abortions.

The abortion drug mifepristone is used for more than half of all abortions in the U.S. every year, or hundreds of thousands of unborn babies, according to the pro-abortion Guttmacher Institute.

But the lawsuit, filed by a group of doctors with the Alliance for Hippocratic Medicine, challenges the U.S. Food and Drug Administration’s approval and later expansion of the deadly drug under the Clinton, Obama and Biden administrations. Represented by the Alliance Defending Freedom, the doctors point to evidence that the FDA ignored safety problems and failed to properly study the risks of mifepristone.

Judge Matthew Kacsmaryk of the Northern District of Texas issued the ruling blocking approval of the dangerous abortion pill. Kacsmaryk issued a ruling in Alliance for Hippocratic Medicine v. FDA that halts Food and Drug Administration (FDA) approval of the chemical abortion drug mifepristone and gave Biden seven days to appeal the ruling.

In his decision, Judge Kacsmaryk noted the following:

• Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion (“2000 Approval”). The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” (pg. 1)
• Most readers would not define pregnancy to be a serious or life-threatening illness. Even FDA does not earnestly defend that position. True, complications can arise during pregnancy, and said complications can be serious or life-threatening. But that does not make pregnancy itself an illness. (pg. 44)
• One study revealed the overall incidence of adverse events is “fourfold higher” in chemical abortions when compared to surgical abortions. Women who underwent chemical abortions also experienced far higher rates of hemorrhaging, incomplete abortion, and unplanned surgical evacuation. (pg. 45)
• Contrary to popular belief and talking points, the evidence shows chemical abortion is not “as easy as taking Advil.” Compelling evidence suggests the statistics provided by FDA on the adverse effects of chemical abortion understate the negative impact the chemical abortion regimen has on women and girls. When women seek emergency care after receiving the chemical abortion pills, the abortionist that prescribed the drugs is usually not the provider to manage the mother’s complications. Consequently, the treating physician may not know the adverse event is due to mifepristone. Studies support this conclusion by finding over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as “miscarriages” rather than adverse effects to mifepristone. Simply put, FDA’s data are incomplete and potentially misleading, as are the statistics touted by mifepristone advocates. (pg. 47)
• The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion — which was the “whole idea of mifepristone.” (pg. 57)

The Texas judge ruled that the FDA cannot allow chemical abortion to be prescribed via telemedicine or without an in-person doctor’s visit, while the Washington judge ruled that the FDA must continue providing the abortion pill in accordance with the Biden-era rule changes.

Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.

The FDA recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies.

“Promoters of these pills like to trumpet high safety rates, but neglect to mention how that with hundreds of thousands of women taking these pills, even a couple of percentage points of women hemorrhaging, dealing with infections, and ectopic pregnancy, represents thousands of women desperately seeking treatment, which may or may not be nearby,” said Dr. Randall K. O’Bannon, Ph.D., director of Education and Research for National Right to Life.

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.

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.

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