Ruling 'puts women’s health above big abortion profiteers'
A federal judge in Texas has suspended the U.S. Food and Drug Administration’s approval of the abortion drug mifepristone in a ruling puts women’s health over abortion industry profits.
The decision by U.S. District Judge Matthew Kacsmaryk on Good Friday will pull the chemical abortion pill from the market, pending legal challenge from the Biden administration. The judge stayed his opinion for seven days to allow the administration time to appeal; this is expected at the 5th U.S. Circuit Court of Appeals.
Kacsmaryk ruled in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that both the initial approval of mifepristone in 2000 along with the more recent FDA decisions permitting the drug to be dispensed through telemedicine, via mail, and at retail pharmacies are unlawful.
Shortly after Kacsmaryk’s opinion was released, a Washington State federal judge issued a ruling that contradicts Kacsmaryk’s, National Review reports, and the case could eventually go to the Supreme Court.
Alliance Defending Freedom sued the FDA in November on behalf of the coalition of doctors and medical associations with the Alliance for Hippocratic Medicine, challenging the FDA’s original approval of the chemical abortion drug, with the argument the FDA failed in its mission to protect the public’s health due to reckless and inadequate screening of the drug.
The FDA had approved mifepristone by characterizing pregnancy as an “illness” and argued that the drug provides a “meaningful therapeutic benefit.”
The group of medical providers argue in the lawsuit that the FDA never studied the safety of the drug under the labeled conditions of use.
Chemical abortion has been shown to have four times the risk of surgical abortion
They say the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions. They argue as well that the FDA ignored the potential impact of the hormone-blocking chemical abortion regimen on the developing bodies of adolescent girls, and eliminated necessary safeguards for pregnant girls and women who undergo chemical abortion.
The Alliance for Hippocratic Medicine also says that for the last two decades the FDA has stonewalled attempts to hold the federal agency accountable for its handling of the approval of the abortion pill.
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As the first in the two-drug chemical abortion regimen, Mifepristone blocks progesterone in a pregnant woman’s system, starving her unborn child of necessary nutrients. The second drug, misoprostol, is taken a day or so later and prompts the mother to go into labor and deliver her deceased child.
Chemical abortion, also known as medical or medication abortion, accounted for more than half of U.S. abortions in 2020, and that figure is estimated to have increased significantly since. It has become even more pervasive following the Dobbs ruling’s May 2022 overturn of Roe v. Wade, since the various laxer modes of procurement associated with it allow for sidestepping local abortion regulations.
Abortion proponents, providers, and chemical abortion pill manufacturers claim the abortion drug is as safe as over-the-counter pain medicine. Any potential financial self-interest aside, these claims gloss over the reality of possible grave hazard for women, who, with the do-it-yourself aspect of chemical abortion, are left to deal with any aftereffects and complications at home, potentially alone.
There are myriad safety concerns associated with the abortion pill, even outside the questions surrounding the drug’s initial approval. Among the minor side effects are cramping, nausea, and vomiting. Severe complications that require immediate medical attention include extremely heavy bleeding, severe infection, and retained tissue.
1 in 5 women require emergency care after taking the abortion pill
In the first six years following mifepristone’s approval, the FDA reported six deaths following intake of the drug, as well as “nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.”
Twelve years later in 2018, the FDA reported 24 deaths and 4,000 adverse events.
More have died in the time since and chemical abortion has been shown to have four times the risk of surgical abortion, with one in five women requiring emergency care after taking the abortion pill.
Additionally, findings from a 2021 longitudinal study showed that between 1999 and 2015 visits to emergency rooms related to chemical abortion increased over 500%. And a Finnish study found that women who'd had a chemical abortion were four times more likely to have adverse events than women who had another type of abortion.
The safety concerns are augmented by the rise of unregulated access and illegal sales of the abortion pill, and its potential for abuse by those who would pimp or traffic women.
Life-affirming pregnancy help is available in every state in the U.S.
Heartbeat International, the world’s largest network of pregnancy help, welcomed Kacsmaryk’s ruling.
“The FDA should pursue the best interest of the people and not the profits of Big Pharma and the ideology of Big Abortion,” said Heartbeat President Jor-El Godsey. “We are grateful that the public interests have been recognized in this case.”
Godsey went on to note that alternatives to abortion are available to women in every state in the U.S. through pregnancy help organizations.
“Life-affirming pregnancy help is available in every state in the U.S.,” he said. “Life States are continually expanding their help to women with unexpected pregnancies. Hopefully, Abortion States will follow suit and provide positive help and not expect women to just have abortions.”
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Heartbeat International’s Senior Director of Medical Impact for Heartbeat International Christa Brown remarked on the potential for Kacsmaryk’s decision to save lives.
“Today we celebrate with those who value the lives of women and children,” Brown said. “These drugs have four times the risk of complications as compared with surgical abortion in studies and should have never been on the market.”
“Halting the dispensing of mifepristone will protect women and children from imminent harm,” Brown added.
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Help is available for those making a pregnancy decision through thousands of pregnancy centers in the U.S.
Heartbeat’s vice president of Communications and Marketing concurred with Godsey on of pregnancy the prevalence of help and its effectiveness as an antidote for abortion.
“Help is available for those making a pregnancy decision through thousands of pregnancy centers in the U.S.,” Andrea Trudden said. “These clinics are helping at the grassroots level, making sure women have options available to them and the support they need.”
“Time and again we see women’s health being pushed aside in favor of abortion,” Trudden said. “By the FDA's own standards, this abortion drug never should have been approved since they never studied the safety under the labeled conditions of use, and they disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions.”
“Thankfully, today the court reversed this dangerous decision and by doing so will ensure that women are treated with dignity regarding their reproductive health, and not as lab rats,” Trudden added. “While this does not erase the pain and suffering that the abortion drug has caused women over the past 20 years–nor the millions of lives lost–it is a step in the right direction that puts women’s health above big abortion profiteers.”
Editor’s note: Heartbeat International manages Pregnancy Help News. This is a developing story; PHN will provide updates as they become available.
