Abortion Industry Goes Too Far For Even the FDA with “Pre-Emptive” Mifepristone

Wish to ship abortion pills to women who are not pregnant

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

Every time the U.S. Food and Drug Administration (FDA) has acceded to demands from the abortion industry to further loosen distribution and prescription limitations on mifepristone, the industry has come back and demanded more, indicating it won’t be satisfied until women can order and self-administer these abortion pills without any medical oversight or supervision whatsoever.

This time, however, the abortion industry’s bullying may have gone too far. Even the FDA cannot turn a blind eye to the fundamental safety issues raised by the industry’s latest demands.

The abortion industry wailed back at the beginning when the FDA approved mifepristone (or RU-486) in September of 2000.  Despite getting their long sought approval, they didn’t like how the FDA required three visits (one for exam and counseling before receiving mifepristone, the second for the clinician to administer the prostaglandin, the third a followup to determine whether or not the abortion was complete), the seven week deadline (up to 49 days past a woman’s last menstrual period, or LMP) the required supervision of physician who could certify they understood the risks and how the drugs worked, the recommended dosages, the ability to treat hemorrhages, failed abortions or refer to someone with the skills to do so.

Faced with an industry that already ignoring most of these conditions and a formal request to revise the label, the FDA agreed to most of these changes in March of 2016. They dropped required visits down to one initial visit, adjusting dosages, raising the cutoff date to 10 weeks LMP, expanding the prescriber pool to include any “certified healthcare provider.”

That turned out not to be good enough for the abortion industry either.  They wanted to forego any requirement that the woman visit the clinic at all, so that she could have her “exam” and counseling over the phone or via a webcam interview, and simply be shipped her pills in the mail.

When COVID hit, they used this as an excuse to petition the FDA to suspend these regulations, arguing that the presence of the virus meant exposing women to additional risks if they had to visit the clinic to get the pills. Various court cases suspended and then reinstated the FDA’s regulations, but even these modest limits were gone for good once Biden took office and directed the FDA review whether the need for these regulations existed anymore.

Under the current regulations, women do not have to visit a clinic at all, do not have to undergo a physical examination, and can simply have the pills mailed to them by a certified healthcare provider.  It is implied that the prescriber, in signing certification forms, has committed to doing some sort of interview to determine the woman’s gestational age (efficacy declines, risk of complications increase the farther along the pregnancy is) and checked for signs of an ectopic pregnancy, which mifepristone does not treat.

Abortion pill advocates, who have been trumpeting the “No-Test” chemical abortion, which claimed women could safely use these pills and manage these abortions without any ultrasound or testing to determine the age or location of the child, found even these minimal safeguards problematic.

They want to be able to ship these pills to anyone who asks for them and let women assess for themselves, however carefully or casually they want, whether the drugs would be safe or effective for them.

And now the industry wants to go one step further, shipping abortion pills to women who are not currently pregnant but wish to stock the medicine cabinet for possible later use “just in case.”

This is a bridge too far for the FDA, an anonymous spokesperson told the Politico in an October 31, 2022 article entitled “FDA says providers offering medication abortion before pregnancy have gone rogue.”

“The FDA is concerned about the advance prescribing of mifepristone for this use,” this spokesperson told Politico. “Mifepristone is not approved for advance provision of a medical abortion.”

This spokesperson explained to Politico that the agency was concerned that if these pills were prescribed before a woman became pregnant, the “providers” would not be able to perform the sort of proper medical oversight that is required to see that these pills are used safety and effectively.

Elaborating, the FDA spokesperson told the Politico that if patients took the pills weeks or months after the original prescription, the “medical professionals” might no longer have the ability to properly date the pregnancy or to rule out an ectopic pregnancy, where the child implants outside the uterus.

Given that ultrasounds and direct physical examinations are no longer part of the official FDA protocol, it is unclear how or why the FDA is now concerned that pre-emptive prescriptions will threaten the ability of clinicians to actively monitor for such red flags. This may be an indication that the FDA interprets current regulations more stringently than do many in the industry.

But whatever the letter of the law requires, it is clear that the abortion industry has pushed the agency too far this time, exposing how little regard the industry really has for actual patient health or safety.

The FDA compromised its own commitment to patient health and safety when it first approved mifepristone for taking the lives of babies in September of 2000, and every time it acceded to another industry request to further loosen abortion pill regulations.

Yet even the team put in place by the Biden administration, who Politicosays “has publicly pledged to do everything within his power to preserve access to abortion,” knowing what it does about the risks associated with this drug, doesn’t believe (for now) it can credibly maintain its standards and authorize this latest irresponsible expansion.

Don’t expect the abortion industry to stop trying.