In response to the 5th U.S. Circuit Court of Appeals decision today in Alliance for Hippocratic Medicine v. FDA, leading pro-life groups are celebrating the court’s decision to rebuke Joe Biden’s mail order abortion scheme.
As LifeNews reported, 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.
But the appellate court’s ruling prohibits abortion businesses from sending chemical abortion drugs through the mail, which the FDA had been allowing since 2021 in direct violation of longstanding federal law. If upheld by the Supreme Court, the ruling will put a massive dent in the mail-order abortion business.
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 to 10 weeks’ gestation—removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System. The 5th Circuit held that the FDA’s 2016 action violated the Administrative Procedure Act and upheld the district court’s conclusion reinstating the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote in its opinion in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. “It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
With respect to the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to the adverse-event data in FAERS after eliminating the provider-reporting requirement, noting that “it’s unreasonable for an agency to eliminate the reporting requirement for a thing and then use the resulting absence of data to support its decision.”
The court further noted that the data the FDA cited in its 2000 approval of mifepristone shows “that thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.”
“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.
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“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.
Susan B. Anthony Pro-Life America affirmed the Court’s finding that the FDA likely violated the law when it loosened safety standards on abortion pills and allowed them to be sent through the mail.
Susan B. Anthony Pro-Life America’s State Policy Director Katie Daniel reacted:
“The FDA ignored science and its own rules when it rubber-stamped Democrats’ reckless mail-order abortion scheme. Americans strongly object to sending abortion drugs through the mail without the in-person supervision of a doctor – that’s common sense. But under multiple Democrat administrations, the FDA threw out common sense and played political games with people’s lives.
“Mail-order abortion pills put thousands of women and girls at risk of serious complications from abortion pills every year. We won’t rest until the FDA and the profit-driven abortion industry are held accountable for the suffering they’ve inflicted on women and girls, as well as the deaths of countless unborn children.”
In-depth polling conducted by CRC Research for SBA Pro-Life America shows that Americans do not believe the FDA’s assertions that mail-order abortion drugs are safe – including 75% who agree the FDA should have performed studies focused on girls under the age of 18 before approving the abortion pill for minors.
Ingrid Skop, M.D., F.A.C.O.G., a board-certified OB-GYN who has practiced in Texas for nearly 30 years and serves as vice president and director of medical affairs at Charlotte Lozier Institute, wrote in an op-ed:
“Like approximately 90 percent of my fellow OB-GYNs, I don’t perform elective abortions. But I’ve personally treated many women for complications from the abortion pill (mifepristone and misoprostol), including performing emergency surgery on a woman who bled for two months after receiving these drugs…Those promoting unsupervised DIY abortion pills clearly prioritize the deaths of unborn children over the health and safety of women. I hope the FDA will once and for all be held accountable to its task of protecting the American public from this dangerous drug.”
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.
For more information about chemical abortion drugs and their dangers, visit abortiondrugfacts.com.
