When it comes to the distribution of the abortifacient drug mifepristone, the United States Food and Drug Administration (FDA) has fallen asleep. Despite comprehensive data showing higher rates of complications and ER visits from chemical abortion, the abortion pill has been praised by corporate media, promoted as “safe” by President Joe Biden, and subjected to scrutiny. increasingly lax oversight by the FDA.
All of this makes a recent under-reported story in Politico all the more interesting. An unnamed FDA source warns against the abortion industry stepping up its campaign to give abortion pills to women and girls who are not pregnant. Politico quotes the unnamed FDA spokesperson expressing concern that this approach poses new health risks for women: “Mifepristone is not approved for the early provision of medical abortion.
The unnamed source goes on to list several safety issues, including the inability of doctors to screen for an ectopic pregnancy or correctly date a pregnancy (the risks of the abortion pill increase exponentially with each week of pregnancy). To this list we add the very real risk that sex traffickers or abusive partners will use the careless distribution of abortion pills to commit crimes of coercion. The Charlotte Lozier Institute has been sounding the alarm about these risks for years, but often falls on federal ears.
There are few signs that the abortion industry cares about these concerns, as even the FDA has given mifepristone a look in recent years. In fact, the FDA has more or less completely withdrawn from its oversight of mifepristone.
The abortive drug regimen of mifepristone (to kill the baby) and misoprostol (to expel the dead baby) was first approved in the final days of the Clinton administration under a settlement aimed at reducing risk associated with hazardous drugs. Known as ETASU, Elements To Assure Safe Use, the regulations were intended to ensure that women obtained abortion medication from a certified physician who could monitor and treat complications. For abortion pills, these complications range from death to bleeding to infection, requiring emergency room visits and, in many cases, follow-up surgery.
FDA relaxed requirements
The original FDA rules also required reporting and tracking of these complications, which turned out to be a good idea. The original mode of administration of mifepristone was found to be associated with fatal infections. Other complications were found to be more common than the rate associated with surgical abortion procedures.
How did the FDA react? This changed the recommended procedure for administration, but curiously, in March 2016 the FDA removed the requirement that only a physician could prescribe the drug and dropped any requirement for the prescriber to report non-fatal complications, exactly the contrary to what one would expect from the FDA. would do to ensure safe use. The goal was to expand distribution of the abortion pill, while learning less from its manufacturers about the dangerous complications the new policy could cause.
The use of mifepristone-misoprostol accelerated after 2016, to the point that it is now the method deployed in the majority of declared abortions. Taking advantage of the declared Covid emergency, the pro-abortion American College of Obstetricians and Gynecologists sued in friendly federal court and won a stay of the in-person dispensing requirement, allowing medication to be dispensed via telehealth and by mail. The decision was overturned by the Supreme Court in late 2020, but not for long.
Then the Biden administration, long before the Supreme Court decision in the Dobbs v. Jackson Women’s Health Organization case paved the way for abortion pills in the mail, perhaps a prelude to the sale of non-prescription drugs. In April 2021, the FDA announced that it was suspending the in-person distribution requirement under the guise of the Covid “emergency”. In December 2021, the FDA decided to permanently allow abortion by mail.
Deeply anti-woman implications
The implications of these policies are profoundly anti-woman and anti-family. Research based on 17 years of Medicaid claims data analyzed by the Charlotte Lozier Institute shows that chemical abortions pose a growing threat to public health, with the rate of abortion pill-related emergency room visits rising by more than 500 % between 2002 and 2015. Using claims data reflects the lack of FDA reporting requirements, exceptionally weak state abortion reporting laws, and only voluntary federal reporting.
The advent of “no test” administration of mifepristone only increases the risks for women and girls. Without a physical exam, ultrasound, lab, or doctor-patient relationship, women can obtain abortion pills by mail or telehealth and initiate an abortion, without confirmation of an intrauterine pregnancy, correct gestational age, and determination of potential risk factors for the future. pregnancy complications.
Imagine being a parent and finding out that your 15 year old daughter somehow got mifepristone and misoprostol through her school, a friend or the internet. Imagine she is one of the women who endures up to 16 days of bleeding from the drug, or is past the 10 weeks of pregnancy the drug is allowed for. Imagine she delivers an extremely premature baby – who at 10 or 11 weeks gestation will have fingers and toes and over 4,000 distinct body parts – in the family bathroom, alone, scared and burdened of an indelible memory.
This is increasingly the state of abortion in America. The abortion industry has routinely cut back on specialized medical care for pregnant women, ignored all standards of care, isolated young people without family support or guidance – and, adding insult to injury – designed programs distribution of abortion pills which will both support and depend on the absence of public health surveillance. The FDA is right to finally be alarmed, but the hour is late.
Charles A. “Chuck” Donovan is president of the Charlotte Lozier Institute. He has worked in the pro-life movement since 1971.