With a decision imminent in the lawsuit that could remove abortion pills from the market and following the FDA’s move to broaden chemical abortion access via retail pharmacies, pregnancy help and pro-life leaders continue to warn of the danger posed by abortion drugs and decry the federal government’s part in pushing the pills.
The U.S. Food and Drug Administration (FDA) expanded access to dispense mifepristone by retail pharmacies in the U.S. in early January – a move viewed as an abortion-boosting concession to the abortion drug’s manufacturers. Initially the abortion drug was only available for dispensing in person with medical oversight and the FDA’s act was one of numerous moves to continually loosen safety protocols since the drug’s approval in 2000.
While the federal government’s slackening of safety practices for distributing mifepristone was stepped up in the last few years with the coronavirus lockdowns as a ploy, concerned pro-life advocates have long said the drug’s very approval was suspect, putting women’s safety at risk - hence the premise for the current lawsuit against the FDA brought by a coalition of medical professionals.
A group of doctors and medical associations with the Alliance for Hippocratic Medicine sued the FDA in November challenging the original approval of chemical abortion drugs, arguing the FDA failed in its mission to protect the public’s health owing to its reckless and inadequate screening of the dangerous abortion drug regimen which includes mifepristone.
The case is unprecedented, having the potential to take the chemical abortion pill off the market, and is therefore at the center of the abortion issue post-Roe v. Wade. It comes after two decades of FDA stonewalling attempts to hold the agency accountable for its handling of the approval of the abortion pill.
The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women when it approved chemical abortion drugs, the suit alleges.
Further: "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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Mifepristone, also known as RU-486, is the first drug in the two-drug chemical abortion regimen. It blocks progesterone, the natural hormone in a pregnant woman’s body that sustains pregnancy, starving the unborn child of necessary nutrients. The second drug, misoprostol, is taken a day or so after the first, and causes the mother to go into labor and deliver her presumably deceased child.
Chemical abortion, also known as medical or medication abortion, now accounts for more than half of the abortions that take place in the U.S., and that figure is expected to rise as abortion supporters and chemical abortion drug manufacturers push for greater access as the antidote to state-level abortion regulations following the reversal of Roe v. Wade in the Dobbs case. Abortion pills are also being sold illicitly online, another way that women are put at risk.
Abortion proponents in and outside of the medical field continually claim the abortion pill is safe , but without an in-person exam by a physician, it cannot be guaranteed that the gestation of a woman’s pregnancy has been correctly determined. Mifepristone has FDA approval through 10 weeks in pregnancy, though there are abortion providers who are dispensing it later than that in pregnancy.
Additionally, the pregnant woman likewise cannot be properly screened for potentially deadly ectopic pregnancy or the serious Rh negative condition without seeing a medical provider in person when seeking a chemical abortion.
Among the myriad safety concerns with chemical abortion, also often referred to as “at-home,” “self-managed,” or “DIY” abortion, is that should the woman face complications she is home, often alone.
A political move
"There is mounting evidence that the abortion pill is forcing women to go to the ER at a rate five times that of surgical abortions,” said Jor-El Godsey, president of Heartbeat International, “and now a lawsuit about the efficacy of the original approval process for RU-486.”
“Seeing the FDA rush to make mifepristone more available with less restrictions can only be seen as a political move,” Godsey said. “Rather than concern for the safety of women, the Biden Administration is actively growing the profits of the abortion industry.”
“This is just the latest effort for abortion supporting politicians to favor their friends at Big Abortion while leaving women all alone in their abortion decision and the aftermath of harmful chemicals," Godsey said.
Paving the way for greater access to unsafe abortion drugs
Women routinely obtain abortion drugs through telemedicine, across state lines, on websites, in markets and pharmacies, and can have them delivered directly to their homes, Heartbeat International’s Senior Director of Medical Impact Christa Brown told Pregnancy Help News. Pharmacies have had the opportunity to become certified and dispense abortion drugs since 2021, she said, however, most have chosen not to do so.
This seems to be a deal between Danco Laboratories, a company that exists solely to sell mifepristone, and all involved in abortion, including the FDA, she said. Another abortion drug company, GenBioPro, manufactures the generic version of mifepristone.
“This paves the way for greater access to these unsafe drugs,” Brown said.
Brown predicted that soon the push will be to have these drugs available over the counter, so the move to get more pharmacies certified to provide the drugs makes sense.
Decisions are based in politics and profits
Still, it will be pregnant women who pay the price for the abandonment of safety standards.
“The FDA exists to protect the public health by ensuring the safety of drugs,” Brown said. “Instead of accurate information and safety for American consumers, women are left to manage their own abortion symptoms at home and ERs across the country contend with growing numbers of emergency cases following mifepristone.”
“As the FDA has continued to cave to Big Abortion, it has failed to protect the women and children of our country,” Brown said. “These decisions are based in politics and profits, not public safety.”
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Brown questioned the reported safety record for the chemical abortion drug.
“Women are frequently needing urgent medical care for heavy bleeding, retained tissue, and infection after starting a chemical abortion,” she said. “All the while, the manufacturer of this drug continues to look for ways to expand sales and collect more profits.”
Brown pointed to various data illustrating the safety concerns.
• A recent analysis of the Adverse Events submitted to the FDA with the REMS in place shows over 3000 women suffering with complications, of which 24 of those women died, and another 500 would have died if they had not reached emergency medical care in time. Average 5-8% of women need emergency room visits for complications - does not even include the number of surgeries done in the abortion clinics.
• Four times the risk of complications as compared with surgical abortion in studies.
• Data released in 2018 by the FDA shows thousands of adverse events caused by abortion pills, including 768 hospitalizations and 24 deaths since 2000.
• Between 2000 and 2021, the FDA documented a total of 4,207 adverse events — including 26 deaths, 1,045 hospitalizations, 603 events requiring a blood transfusion, and 413 infections.
• One-third of women (34%) who had a chemical abortion “reported an adverse change in themselves, including depression, anxiety, substance abuse, and thoughts of suicide,” according to a study of post-abortive women conducted by the group Support After Abortion.
“The messaging comes across to consumers that there is new evidence showing mifepristone to be safer than previously thought,” Brown said. “However, others, including thousands of women harmed by these drugs, know the truth.”
Politics before science
The case challenging approval of chemical abortion drugs is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration and is the first of its kind.
The FDA put politics before science when it pushed for legalization of the drugs in 2000, a statement from Alliance Defending Freedom (ADF) said. ADF is representing the medical associations and doctors in the suit.
“The only way the FDA was able to approve the drugs was by characterizing pregnancy as an “illness” and arguing that these drugs provide a “meaningful therapeutic benefit,” the legal non-profit said.
“The FDA’s approval of chemical abortion drugs has always stood on shaky legal and moral ground,” said ADF Senior Counsel Erik Baptist, “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.”
Different pro-life organizations, 67 members of Congress, and 23 states have supported the Alliance for Hippocratic Medicine in 15 friend-of-the-court briefs in the case, according to ADF. The case is filed in U.S District Court in the Northern District of Texas, Amarillo Division.
A decision in the case is expected at any time. If the plaintiffs succeed the FDA would be forced to withdraw its approval of mifepristone, and the abortion drug’s manufacturers would be barred from shipping it anywhere in the U.S.
Editor's note: Heartbeat International manages Pregnancy Help News.
