FDA authorizes telemedical abortion, home use of abortion pills

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

On December 16, 2021, the U.S. Food and Drug Administration (FDA) announced that it had completed a review of chemical abortion regulations launched by the Biden administration in May, determining whether the abortion pills could be shipped to women’s homes without a woman first seeing a doctor.

Here’s a breakdown of decision and some of its implications.

What did the FDA do?

The FDA declared that the suspension of a rule made during COVID, requiring that women pick up their abortion pills in person at the clinic, the doctor’s office, or hospital was going to be made permanent. This means authorized prescribers can, in fact, meet and screen potential patients online and ship qualified persons pills in the mail, which women can then take on their own at home. The FDA also added pharmacies to the list of approved distributors, so long as they undergo the same certification process as other prescribers.

Essentially, this allows prescription by telemedicine with authorized prescribers. However, it does not make mifepristone generally available for purchase online, over the counter, or from doctors or medical personnel who have not undergone certification.

Are there still any limits in place?

The FDA did not authorize drug makers or online pharmacies to simply ship pills to anyone who wishes to order. Prescribers still have to certify that they have the ability to date pregnancies, diagnose ectopic pregnancy, and either have the surgical training to address incomplete abortions and handle any complications or have in place arrangements for women who need such care to obtain it.

Those prescribing and providing the pills will also still have to agree to provide, sign and review a patient agreement form explaining the procedure and its risks and to make sure that each patient has her own copy.

How does telemedical abortion with mifepristone work?

Telemedical abortion works pretty much in the same way that chemical abortions work with drugs obtained at the clinic, just without the more comprehensive screening and follow up that would be available onsite.

After being screened to determine gestational age (the pills effectiveness drops the farther along the child’s development), to check for ectopic pregnancy (the pills do not work in circumstances where the child has implanted outside the uterus), or other contraindications (allergies, other conditions that might make use of the pills particularly dangerous), the woman is prescribed one pill of mifepristone and four pills of misoprostol, a prostaglandin.

She takes the mifepristone which blocks the action of the pregnancy hormone progesterone, essentially shutting down the baby’s life support system and giving a woman’s body the false signal that no pregnancy has occurred, eventually initiating menstruation. The second pill, misoprostol, taken a day or so later, initiates powerful uterine contractions to dislodge and expel the child and other bloody tissue from the woman’s body.

Some sort of follow up is expected to determine whether or not the abortion is complete or whether some sort of additional drugs or surgery is required to complete the process or deal with continued bleeding or remaining tissue.

With telemedicine, all these steps are supposed to occur at the woman’s home, with all interactions between prescriber and patient managed online or telephonically.

Is home use more dangerous?

All chemical abortions come with a certain degree of risk and the possibility of failure.  The most recent information from the FDA indicates that 26  women who have tried to use these pills to abort have died. Thousands more have suffered complications or “adverse events” such as hemorrhage, infections, or the rupture of ectopic pregnancies that originally went undetected.

Various “success” rates have been published in the literature, but the most recent patient agreement form (3/21) from the FDA says chemical abortions do not work for “2 to 7 out of 100 women who use this treatment.” Failure and complication rates are higher for those women with later gestations.

Doctors who see these women in their offices are able to examine the women more carefully, to use ultrasound to more accurately date the pregnancy and to check for ectopic pregnancy, where the child is implanted outside the womb. The abortionists who prescribe these pills after an online consult have to rely on a woman’s honesty and accuracy regarding her last menstrual period to determine whether or not she is past the ten week cutoff date and have to hope that they can uncover signs of an ectopic pregnancy from a few questions.

If there is any dating error, or the signs of an ectopic pregnancy have not yet become evident, there is a greater likelihood that the woman having the telemedical chemical abortion will see her abortion fail or will face serious complications like hemorrhage or a uterine rupture.

Because the potential for misdating, for missed ectopic pregnancy is inherently more likely with telemedicine– more complications, more failed or incomplete abortions seem likely. [1]

Not only is the frequency of failure or complications more likely with telemedicine,  the conditions may make these more severe and potentially deadly. If one of the selling points of telemedical abortion is that women do not need to travel what could be a significant distance to their “provider,” then there is a concern that they may not be near enough to receive the sort of emergency help they might need if and when something goes wrong.

While a woman who received her pills directly from the abortionist at the clinic can return to that clinic for treatment if she starts gushing blood or can maybe get to her local emergency room if she starts showing signs of an infection, a woman living in a more remote area of the country may not have that sort of help available.

Sadly, this is the sort of increased risk that the FDA and the abortion industry appear willing to take.

What are the abortion industry’s aims here?

Though couched in terms of the usual spin about “increasing women’s options,” the clear aim of the abortion industry is to be able to continue to promote and sell its deadly product if, when, and where abortion is limited by law, clinic closures, abortionist shortages, community disapproval, or other circumstances.

They want to be able to continue enabling women to abort their babies even if there are no clinics nearby, even if their state tries to legally protect unborn children, and even if women have qualms or concerns about surgical abortion.

Chemical abortion, particularly if provided by telemedicine, they think, does that. There doesn’t need to be a clinic, an abortionist anywhere in the state or within hundreds of miles.  A state law that closes down a clinic keeps an abortionist from setting up a practice can be bypassed by a box of pills delivered to a woman’s home by overnight mail. 

The reality of chemical abortion is bloody, painful, time consuming and may involve a haunting face-to-face encounter between an aborting mother and her child. However, most women taking these drugs don’t realize that until too late, after they’ve bought the false advertisements of a safe, simple, easy abortion and are in the throes of gut wrenching physical and psychological nightmare that is chemical abortion.

None of it matters to the abortion industry, so long as they beat any abortion legislation and are able to continue selling their product.

What’s next?

Though it is clearly a dark day for American women and their babies, the abortion industry did not get everything it wanted from the FDA. They had hoped for the full rescission of the FDA’s Risk Evaluation and Mitigation Strategies (REMS) regulations, to get the FDA to drop all certification requirements involved in buying and prescribing the pills.

They want these to be sold over the counter, to be available to anyone with a credit card over the internet, they want women to buy bottles of pills ahead of time and keep them in their home medicine chests.

While abortion advocates will certainly celebrate this decision and the abortion industry will quickly work to expand this option in states where this is allowed, expect them to continue pressing the FDA to abandon whatever limits remain on the abortion pills prescription and distribution.

Pro-lifers will have to work to defend state laws which prohibit the mailing of abortion drugs or require them to only be distributed in person. But a great deal of the outcome will depend on what might be done to inform women of the dangers of chemical abortion, the negative consequences of abortion in general, and the possibility of life preserving positive alternatives to abortion.

False claims about the ease and safety of chemical abortions have helped to drive the recent slight increase in abortions in the U.S., and the abortion industry probably hopes that its false promises of safe and easy telemedical abortions will drive a new resurgence. 

But as women find out what these abortions are really like, as they begin to hear about, or experience the increased failures, the serious complications that accompany this new method, as they begin to figure out that what they are being sold is just a new, more dangerous form of destruction, hopefully they’ll turn away from this latest call of the sirens and reconsider the better deal that life offers.