Medical studies, health department data, statistics from emergency rooms and anecdotal evidence from doctors and researchers all confirm the abortion pill mifepristone is dangerous for women.
But with the Supreme Court holding hearing soon on the abortion pill and the dangers associated with the FDA’s improper review of the drug and removing of information about the dangers and risks associated with it, one medical journal is hiding studies that women should see before they take mifepristone.
One of the now-retracted studies, published November 9, 2021, found that the rate of emergency room visits following chemical abortions had spiked 500% from 2002-2015, according to Medicaid claims data. Another one of the studies, published May 20, 2022, analyzed the likelihood of recurring emergency room visits for women who did not disclose to doctors that they had a chemical abortion.
These two studies were cited in Kacsmaryk’s decision to suspend FDA approval of mifepristone.
The nation’s highest court will hear oral arguments this Spring in a case that could put a halt to mail-order abortions that kill babies and injure or kill women.
As LifeNews reported previously, in April the 5th Circuit Court of Appeals issued a ruling that banned mail-order abortions that put women’s lives at risk, 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.
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.
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.
The maker of the dangerous abortion drug appealed along with the Biden administration.
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The U.S. Supreme Court will hear oral arguments on March 26 in the case.
Alliance Defending Freedom Senior Counsel Erin Hawley, told LifeNews she is glad SCOTUS will hear this important case and expects the lower court decision to be upheld.
“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. 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.”
Ingrid Skop, M.D., F.A.C.O.G., a board-certified OB-GYN who serves as vice president and director of medical affairs at Charlotte Lozier Institute, shared her reaction, told LifeNews that the case is vital because abortion pills kill and injure women.
“As a practicing OB-GYN with over 30 years of experience, I have seen first-hand what the abortion pill regimen has done to my patients, both mother and child. As many as one in five women will suffer a complication such as hemorrhage or infection, and I have cared for many of these women in the ER. The Biden administration’s decision to weaken commonsense safeguards and remove doctors from the process shows they prioritize abortion on demand over the mother’s safety. I hope the Supreme Court realizes that the lives of many babies and women are at risk. The FDA must be held accountable for its callous actions.”
Recently, Mississippi Attorney General Lynn Fitch led a coalition of 19 State Attorneys General in filing an amicus brief in the U.S. Supreme Court in support of the medical professionals in the case of Alliance for Hippocratic Medicine v Food and Drug Administration.
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“Since the day the Court returned important abortion policymaking to the people with the Dobbs decision,” said General Fitch, “the Biden Administration has single-mindedly pursued an agenda to remove that policymaking from the people’s elected leaders in the states and install it with administrative agencies.”
She told LifeNews: “The Supreme Court has affirmed the right of the people to balance competing interests, make considered judgments, and write the laws that protect the health and well-being of women and their children. We cannot allow the Administration to do an end-run around democracy, especially when bypassing the democratic process carries with it serious life or death implications.”
In their brief, the Attorneys General lay out the steps take by the FDA over the past two decades that have increasingly set aside protections for women’s health in blind pursuit of a political agenda:
In 2000, the FDA approved the drug mifepristone for chemically induced abortions. That approval was legally flawed, but it at least included measures to account for mifepristone’s risks to life and health. The approval extended only through 49 days of pregnancy; allowed mifepristone to be dispensed only in clinics, medical offices, or hospitals (all under a certified prescriber’s supervision); mandated three in-person office visits; and required providers to report all adverse events from the drug. Yet over time the FDA cast those measures aside. In 2016, it rolled back many safety requirements—allowing mifepristone to be prescribed through 70 days of pregnancy, by non-doctors, and with only one in-person visit—and stopped requiring prescribers to report non-fatal adverse events from the drug. And in 2021, the agency abandoned the inperson-dispensing requirement. The FDA now condones a broad mail-order abortion-drug regime.
The District Court held that the FDA’s core actions on mifepristone are flawed and stayed them. The Fifth Circuit Court of Appeals upheld that ruling in part, noting that the FDA failed to study the cumulative effect of various changes it approved for use of the drug, including the removal of any requirement that a medical professional determine a pregnancy was not ectopic or past the recommended gestational age, and further noting that simultaneously the FDA removed any reporting of non-fatal adverse events pursuant to use of the drug. The parties are now seeking review by the U.S. Supreme Court.
Attorneys General from Alabama, Arkansas, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, Wyoming joined General Fitch on this brief.
In its ruling this Spring, the three judge 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 5th Circuit also agreed with Alliance Defending Freedom attorneys that the FDA’s approval of generic mifepristone was unlawful, and that the manufacturer must cease production by Friday.
“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented. The FDA should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls,” said ADF Senior Counsel Erin Hawley.
She told LifeNews, “Federal agencies that act lawlessly must be held accountable. The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades. The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”
The appeals court did not evaluate all of the safety arguments in the case, but it said that the F.D.A. “cannot deny that serious complications from mifepristone” occur. The court also said that the F.D.A. was incorrect in saying that mifepristone was comparable in safety to ibuprofen. “F.D.A.’s own documents show that mifepristone bears no resemblance to ibuprofen.”
In its decision, the 5th Circuit ruled that abortionists are no longer allowed to send chemical abortion drugs through the mail, which the FDA had been allowing since 2021, in direct violation of longstanding federal law. The appeals court agreed that the Comstock Act prohibits mailing abortion drugs and it said the doctors who brought the case had legal standing because they had treated so many women injured by abortion drugs.
The appeals court said that “as a result of F.D.A.’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects. This harm is sufficiently concrete.”
Since the ruling, a Nevada woman has died following a botched abortion at Planned Parenthood, the nation’s biggest abortion business.
Alyona Dixon, 24, died on September 28, 2022 after complications from the abortion forced her to seek emergency medical treatment four days after the abortion at Planned Parenthood. Her family is now suing the Las Vegas hospital that treated her, saying it did not provide adequate medical care for the abortion complications.
At the Planned Parenthood abortion center, Dixon received the dangerous mifepristone abortion pill that has killed dozens of other women and injured thousands. The pill has been linked to sepsis, which has killed other women taking the abortion drug, including Dixon.