FDA rule changes could lead to greater illness, death, say pro-life ob-gyn, medical associations.“The abortion industry aims for the absolute minimum in safety and patient care.”
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The U.S. Food and Drug Administration’s directive allowing abortion pills to be sold by retail pharmacies eliminates important safeguards protecting pregnant women, says the head of a professional association of obstetricians and gynecologists.
While in the past, women had to have an in-person examination before obtaining a prescription for the drugs, the FDA during the COVID-19 pandemic began allowing prescriptions to be made after a telehealth visit. But patients still had to go to a certified clinic to fill the prescription. Retail pharmacies were barred from dispensing the drugs.
On Tuesday, the FDA permanently eliminated the requirement of an in-person visit and allowed pharmacies to begin carrying the medication. Women still need to have a prescription.
Medication abortion consists of two drugs: mifepristone, which cuts off the flow of a hormone needed to maintain a pregnancy during its first trimester, and misoprostol, which causes contractions to expel the dead fetus. Approved some 20 years ago by the FDA, the regimen is considered safe for the mother up to the 10th week of pregnancy.
Coming six months after the U.S. Supreme Court’s Dobbs v. Jackson decision allowed individual states to regulate abortion, with many states now banning the procedure, the FDA’s announcement was hailed by pro-abortion advocates as a step allowing greater access to pregnancy terminations. It raises the possibility that women living in states where abortion is illegal can now more easily terminate early pregnancies by obtaining a prescription through an online health consultation, then traveling to a state where she can legally fill the prescription at a pharmacy.
But in the view of Dr. Donna Harrison, Chief Executive Officer of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the FDA was “irresponsible” to liberalize the rules.
The agency, Dr. Harrison said, is “abandoning the requirement that girls and women be examined before receiving a powerful abortion drug. Without an examination you don’t know if a woman has an ectopic pregnancy, which the abortion pill does not treat.”
Harrison said that one in every 50 women will have an ectopic pregnancy — a condition where the fetus develops outside the uterus, usually in a fallopian tube. Untreated, it can lead to rupturing, hemorrhaging, and possibly death. A woman taking the abortion pill, not knowing that she has such a condition, might think that her pain and bleeding are the normal side effects she was told might occur with the medication, Harrison said.
“I’ve personally reviewed the adverse effects reports that have been submitted to the FDA, and you have a number of women who have already died from an unrecognized ruptured ectopic pregnancy,” she said.
A key element of an in-person exam is an ultrasound, which would help a doctor determine how far along in a pregnancy the patient is. If a chemical abortion is incomplete — leaving parts of the fetus inside the womb — the patient will need another type of abortion, depending on the gestation of the pregnancy.
“The complications from a seven-week pregnancy, say — that is, three weeks after you miss your period — are about 5%,” Harrison said in an interview. “So about 5% will need a D&C [dilation and curettage] to complete the abortion. But if you’re at 13 weeks, which is just a month or so off, one out of three women need a surgical abortion, and many of those women need it for hemorrhaging. So without knowing exactly how far along the woman is, she has no way of knowing her risks, and you can’t evaluate that over the internet. You actually have to see the woman and actually have to have an ultrasound.”
Harrison admitted that a doctor conducting a telehealth visit could have the patient visit an imaging center for an ultrasound and not write a prescription until he gets the results. “But the whole reason for telemedicine availability of abortion was to reduce or eliminate the need for physician involvement,” she said. “The abortion industry aims for the absolute minimum in safety and patient care.”
The Catholic Medical Association also criticized the new FDA rule, saying the agency acted without regard to the “documented risks to women of the use of mifepristone: hemorrhage, infection, and retention of fetal remains (incomplete abortion).”
“The minimal safety provisions do not require the physician to be even in the same state where the pharmacy is dispensing the drug (mifepristone),” said Dr. Lester Ruppersberger, former President of the Catholic Medical Association, and Marie T. Hilliard, Senior Fellow at the National Catholic Bioethics Center, in a statement provided to Aleteia. “The FDA admits there is the potential for excessive bleeding and that there have been 28 deaths associated with the use of this drug. And while the FDA requires that the prescribing physician be able to provide or arrange for emergency care if side effects occur, how timely can that be with a physician miles away? Furthermore, no onsite or in-person physical assessment to even document the weeks of gestation or the location of the fetus is required. No follow-up physical examination is required to assess for an incomplete abortion and the resulting risks of continued bleeding, retained products of conception necessitating surgical removal, or infections, which can lead to infertility and in extreme cases even death.”
Dr. Harrison, a board-certified ob-gyn, said the potential for life-threatening bleeding is significant. “Mifeprex [the brand name for mifepristone] interferes with the ability of a woman’s womb to clamp down and stop bleeding,” she said. “So the hemorrhage that you see with Mifeprex complication abortion is massive hemorrhaging.”
The risk of life-threatening infection is also increased because Mifeprex suppresses a woman’s immune system, making it more difficult for her to fight off serious infection, she said.
Both AAPLOG and the Catholic Medical Association also warn of the potential for abuse when a woman seeking a chemical abortion can obtain a prescription without an in-person visit.
“With a telemedicine visit, you have no idea who is standing behind the screen,” Harrison said. “So this is a perfect opportunity for pimps and abusers to coerce abortion. And even then you don’t know if the woman who is ‘applying’ over the internet is the same woman who is going to receive the drug. There’s huge potential for abuse.”