By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. This appeared in the first post-Roe edition of the “Prolife Newspaper of Record”. Please share this story and the remainder of this issue with pro-life family and friends. This is adapted from Dr. O’Bannon’s June 24th speech at NRLC Convention 2022.
Today, we stand at the threshold of what looks to be a whole new era, the first time in nearly 50 years that abortion has not been treated by the Supreme Court as some sort of “super duper” right or precedent hidden somewhere in the shadowy emanation and dark penumbras of the Constitution.
A great day in which our states can finally pass laws protecting unborn children and their mothers from the horrors of abortion without the threat of Roe handing over our work.
It is not a day, however, when we should expect abortion’s long time defenders and supporters to suddenly give up their efforts. Far from it.
Just as this is a day we have long worked and prayed for, it is also a day that our opponents on the other side have been planning and preparing for for decades. They have developed a particular type of abortion – chemical or “medication” abortion with pills – that they can perform on a woman without her ever having to come to a clinic, one where she can order abortion pills on line and have them delivered to her home.
Abortion pills that they think you and your state cannot effectively legislate against, whose sale you cannot easily monitor or prohibit.
It is a time of great possibility and of great danger. So exactly how did we get to where we are today and what can we do about it?
A very old dream
1973 certainly wasn’t the first time women first woke up pregnant and decided they didn’t want to be.
As far back as Ancient Times we encounter recipes for herbal concoctions that were supposed to help women “strip off” or “loosen the child” in the her belly. These “potions” included dangerous chemicals like mercury or sulfur or bizarre combinations of herbs like wormwood, pennyroyal, castor beans and other delicacies like fermented dough or crocodile dung that could either be drunk, eaten, or inserted into the birth canal and act as a pessary.
None of these every really caught on in any major way. Most women only experienced two basic outcomes – either those potions didn’t work, or, if they did, they were as likely to kill the woman as to kill her child.
Though some of these herbal recipes continued to exist on in fringes of folk medicine over the next several centuries, the medical profession as a whole began to turn towards surgical methods in the 18th and 19th century. Even still, surgical abortion didn’t become common for at least a hundred years more when physicians learned how to control bleeding, infection, and pain with better surgical techniques and improved antiseptic methods.
While surgical techniques advanced, advocates of abortion never entirely gave up on the idea of finding a chemical abortifacient.
When the pregnancy hormones progesterone and estrogen were discovered in 1929 and 1934, a whole new avenue of research opened up.
Gregory Pincus used funding from Margaret Sanger and his own knowledge of hormones and steroid receptors to develop the progesterone based birth control in the late 1950s.
Though not the abortion pill we know today, in the process of his research, Pincus theorized that any drug that could be developed to counteract progesterone, it could also function as an “implantation inhibitor.”
A young French chemist named Étienne-Émile Baulieu who visited Pincus during trials of birth control pills in Puerto Rico in 1961 was intrigued by Pincus’ theory. When Baulieu returned to France, where he was working as a consultant to pharmaceutical maker Roussel Uclaf, he began looking for chemical compound which could block progesterone.
A functional abortifacient hits the market
Under Baulieu’s direction, Roussel scientist George Teutsch discovered RU-486 in 1980, the antiprogesterone drug they were looking for. Baulieu tested his new compound, given the generic name mifepristone, in 1981, aborted nine of the 11 pregnant women upon whom he tested. He announced his “success” in 1982 and petitioned the French government to approve his “abortion pill”
France told Baulieu to add a prostaglandin to increase effectiveness and then approved mifepristone for sale in 1988. China put out its own version later that year. Approvals in Britain and Sweden followed within a couple of years.
Of course, once the abortion pill got approved in Europe, the American media and abortion lobby began clamoring for the abortion pill to be brought to this country.
Once President Clinton took office, he set the U.S. Food & Drug Administration (FDA) to the task of bringing the abortion pill to the U.S. After wrangling with the French company over American rights to the pill, an American group did national testing of the pills and arranged to have them manufactured in China. Ultimately Mifeprex – mifepristone’s trade name – was approved for use September of 2000.
Abortion advocates like to tell this as a tale of triumph, of progress, as the introduction of a new, easy, safe, simple, effective alternative to the already old, increasingly unpopular, surgical abortion.
It was presented as a softer, kinder, “more natural” abortion for women who were turned off by the intimidating, mechanical, bloody cutting of surgical abortion. The industry saw it as a way of enlisting a whole new class of doctors, nurses, and others in the cause who weren’t surgically trained, and never had an interest in adding surgical abortion to their practices.
But even with approval, it was a mixed verdict. The FDA did not simply approve the drug for general use. It approved the drug under “Subpart H,” a special administrative rule that allowed the FDA, because of the drug’s inherent safety issues, to set a number of conditions on mifepristone’s use and distribution.
Approval came with strings attached
Here’s what the FDA mandated: Two drugs, three visits, for women no more than 7 weeks LMP (Last Menstrual Period).
This was just the start. There were more limits, each one hated by the abortion industry.
Women were to be no more than 49 days pregnant (measured since their last menstrual period – the baby would be two weeks younger). They were to visit the clinic, be screened and counseled to make sure they were the appropriate gestational age, did not have an ectopic or tubal pregnancy, and then receive three pills of mifepristone, which they took there in the doctor’s office. Those pills began the process of blocking progesterone in her system, shutting down the baby’s life support system and initiating the shedding of the child and uterine lining.
They came back two days later to take the prostaglandin, misoprostol, to initiate powerful uterine contractions to expel the dead or dying baby. In the FDA’s original protocol, the woman came back a third time at two weeks to determine whether or not the abortion was complete or additional drugs or surgery were required to complete the abortion.
The FDA also declared that these drugs would only be available directly from the U.S. distributor. They were only to be prescribed and administered under the supervision of a physician certified able to date pregnancies and diagnose ectopic pregnancies. The ordering physician had to be able to provide emergency surgical backup for failure, bleeding, or refer to someone who could do so. Paperwork on risks and procedures had to be signed by both patient and prescriber. The FDA required mandatory reporting of failures, complications, and deaths.
The FDA had considered more protections than these. Abortion advocates successfully talked the FDA out of requiring surgical training or mandating ultrasounds, but they were still unhappy with the restrictions the FDA left in place.
Their immediate complaints were the dosages, the cutoff date, and the required second visit, However, advocates made clear that they wanted even more concessions.
Ignoring the FDA, paying the price
Almost immediately, abortion advocates began promoting an alternate protocol of their own. They wanted reduce doses of the more expensive mifepristone (from three pills to one) and doubling the dose of the cheaper misoprostol prostaglandin.
Instead of taking the misoprostol orally in the office, they gave women the misoprostol at their first visit to take home and self- administer vaginally. Some of the follow up seems to have been done over the phone rather than in person.
Evidence that the FDA’s safety concerns were justified began to surface once the abortion pills hit the market. A young teenage girl from the San Francisco area died in 2003 after coming into contact with a rare bacteria. Soon information surfaced that the same rare bacteria, Clostridium sordellii, had killed at least four other mifepristone patients. All had used the vaginally self administered misoprostol of the National Abortion Federation’s alternate mifepristone protocol. Some felt was how the deadly bacteria entered their system.
News then came out about Swedish and British teens who had bled to death after taking mifepristone. A mifepristone patient in Chattanooga died when her undetected ectopic pregnancy ruptured.
The FDA’s official record showed other deaths and hundreds of women hemorrhaging, getting infections, being hospitalized, having their ectopic pregnancies missed by the doctors prescribing their pills.
The FDA investigated the deaths, issued public health advisories, added warnings to the label. But instead of reconsidering the pill’s safety and the wisdom of their industry protocol and its modifications, abortion advocates continued to push for even fewer restrictions.
FDA caves (somewhat) to unrelenting abortion industry pressure
After years of pushing by abortion advocates, the FDA, under President Obama, granted some of these requests in March of 2016. They adjusted the dosages, allowing the misoprostol to be taken at home (though not vaginally), extended the cut off to 10 weeks, and broadening the list of approved prescribers to any “certified health care provider.”
All these changes made it easier, cheaper, and more convenient for abortionists. Nothing made it safer.
Advocates were still not satisfied. A group of abortion all-stars calling themselves the Mifeprex REMS Study Group published an article in the February 27, 2017, issue of the New England Journal of Medicine. They argued that after 16 years of “overregulation” it was time to “unburden” Mifeprex.
However, even while modifying the protocol to meet many of the abortion lobby’s demands, the FDA continued to keep the abortion pill under strict distribution limits – still requiring certification of prescribers, still requiring paperwork, still requiring that patients come to the clinic to receive their pills and receive necessary instruction and counseling.
In 2011, the FDA put mifepristone under its new safety monitoring program, its “REMS” or Risk Evaluation and Mitigation Strategies program. This is “a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
Again, advocates were concerned that these regulations gave women the (fully accurate) idea that these pills were dangerous. They also felt all the certification process discouraged many would be prescribers, doctors, nurses, and clinicians. They felt they would find this process, and all the accompanying paperwork, unnecessary and onerous.
Using COVID for Cover
When COVID hit, abortion pill advocates saw their opportunity. They said women could have their consultations virtually, on the computer or over the phone. They argued that women didn’t need to expose themselves to the virus by coming into the clinic for their pills.
Backed by their political allies, abortion advocates, sued the FDA in the courts to suspend the REMS regulations. A federal district judge accepted their argument and ordered the FDA to comply in July of 2020. Though the Supreme Court overturned that and reasserted the FDA’s authority to regulate the use and distribution of drugs in January of 2021, that victory was short-lived.
Shortly after the Biden administration took over, it directed the FDA to suspend the REMS again in April of 2021 and pledged to consider overturning the regulations permanently before year’s end. This it did, in December of 2021, saying the drugs no longer had to be dispensed in person and pharmacies could become certified prescribers. The FDA kept some of the basic REMS regulations in place, still requiring certifications, paperwork, limited distribution, and keeping a ten week cutoff. But essentially the FDA authorized abortions by telemedicine and set it up that the drugs could be shipped from on-line pharmacies.
Even before the latest tussle over regulations, there were renegades like Dutch abortion activist Rebecca Gomperts with Aid Access who were already selling unauthorized foreign abortion pills online. But as soon as the rules were first suspended in 2020, many telemedical, online providers in the U.S. sprung up, such as Choix, Just the Pill, Hey Jane and online pharmacies like HoneyBee Health. These had much more liberty to promote themselves and their products once the FDA’s rules on in person distribution were permanently dropped.
Many of these may have been more entrepreneurial than medical ventures, perhaps seen as a chance to make a quick buck. But the industry as a whole wanted much more.
Insurance against Roe’s fall
Abortion advocates have been aiming for abortion pills that can be given to women with NO rules, no oversight whatsoever, no exams, no tests, and no direct consultation. They have made clear that they want women to be able to buy these over-the-counter, without a prescription, to be able to stock and keep in their home medicine chest for us “as needed.” Essentially, “DIY” or “Do it Yourself” abortions.
What had been implicit for many years has been made explicit in the last few months: abortion advocates have been playing the long game. For more than three decades, they have been developing a unique product, clearing all obstacles that stood in the way of an abortion method that could bypass all the rules, the laws, the normal medical safeguards, one that can be ordered online and sent directly to a woman’s home. One that she can access even if abortion is illegal in her state.
Over the last several years, they have methodically gotten rid of every legal and logistical barrier that stood in their way. They’ve had insiders – their good buddies in the industry – do studies supposedly establishing the safety and efficacy of telemedical chemical abortions, of pills delivered to women who have not been examined, have not received an ultrasound to determine their gestational age or identify ectopic pregnancies, who have not been checked for the Rh factor which can harm future pregnancies, whose completion of the abortion process has not been verified.
They’ve infiltrated and corrupted the some of the nation’s top medical societies and convinced sympathetic government authorities that the high numbers of patients lost to follow up can just be ignored, that hundreds or thousands of women being hospitalized for bleeding, for severe infections, for ruptured ectopic pregnancies, for surgery for incomplete or failed abortions really don’t matter and don’t affect the drug’s safety or efficacy profile.
To them, everything’s fine so long as a young woman can go online, see an unrealistically rosy sales pitch about a safe, simple abortion, and then order pills sent to her in an unmarked box or envelope.
Those who have problems are welcome to try to get to their local ER before they bleed to death. It’s all good, so long as abortion advocates have a way to continue the killing and keep the industry going after Roe’s fall.
A tough road ahead
We have been watching and we have been preparing for this development.
Many states have passed regulations either directly prohibiting the online prescription and mailing of abortion pills or have at least mandated that these pills only be dispensed in person by a physician who has met, counseled, and examined a woman.
These laws have already kept many of these groups from marketing telabortions in those states.
But they are challenging our laws in the courts and looking for ways around them. They are angling to have doctors in other states ship pills across state lines. They are actively talking about prescribing these pills in states where mail order abortion pills are prohibited by claiming they are being shipped not for abortion, but for “miscarriage management.”
Of course, they are still pushing the FDA to drop the REMS entirely. They want to skip the telemedical interview entirely and just have women fill out an online application. They want this available for sale over the counter.
We are continuing to tweak our laws to address the new realities. We are considering some new ideas. We are beefing up our education program so that women know how dangerous these abortion pills are and what they do to their babies.
But with Roe now consigned to the dustbin of history and states gaining the power to limit abortions, this is where the battle is going to be played out over the next several years.
So let’s celebrate our great victory, but be prepared. Stop thinking of abortion as something only done at dilapidated clinics by old grey haired abortionists with a tired suction machines or a rusty scalpels. The new, modern menace is a chemical or “medical” abortion with pills ordered online and mailed directly to a woman’s home. It’s hard to detect and even harder to control.
Can it be stopped? Yes. Will it be easy? No.
But we have faced tough challenges before, and we have triumphed with compassion, determination, and ingenuity. It’s going to take every bit of that to win this fight.