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Questions & Answers on the FDA’s Latest Decision to Allow Pharmacies to Stock and Sell the Abortion Pill Mifepristone

by | Feb 14, 2023

Part Two: Will new regulations make use of the abortion pill more dangerous?

By Dave Andrusko

Today, Dr. Randall K . O’Bannon, National Right to Life’s resident expert on chemical abortion, answers more questions about the FDA’s latest decision to allow pharmacies to stock and sell the abortion pill.  Read Part One here.

Q. Why the focus on mifepristone?  Doesn’t the typical chemical abortion involve two drugs – mifepristone and misoprostol?

In official announcements, the FDA generally refers primarily to mifepristone, the popularly known “abortion pill” developed in France in the 1980s originally designated as “RU-486.” But the drug has almost from the beginning been used in conjunction with a second drug, a prostaglandin, typically misoprostol. Mifepristone blocks the action of the pregnancy hormone progesterone, vital to maintaining the safe and nutritive environment for the developing child planted in the uterine wall.  With that progesterone signal blocked, the child is starved or suffocated and begins to shrivel.  But because mifepristone is not always totally “effective” on its own, the abortionist gives the woman misoprostol, a prostaglandin which triggers powerful contractions to expel the dead or dying corpse from the mother’s uterus.

While the U.S. sponsor of the abortion pill specifically sought and obtained the FDA’s marketing approval for mifepristone, the approved protocol actually lists and requires the use of both of the drugs in tandem. Mifepristone is taken the first day, misoprostol is taken a day or so later after the mifepristone has had time to do its work.

Though misoprostol can and has been used by itself as a stand-alone abortifacient, particularly in countries where mifepristone has not been approved, it is believed to be less effective than the combo of mifepristone and misoprostol used together.

The manufacturer of misoprostol has never sought approval for this abortifacient use.

Misoprostol was developed and approved for an entirely legitimate medical use, long before its forced association with mifepristone, as an anti-ulcer drug for people who have to take a lot of NSAIDs, or “non-steroidal anti-inflammatory drugs” or medications.

Because of its legitimate medical purpose and because the manufacturer does not support its use as an abortifacient, there is no good reason to try and control or limit misoprostol’s use or prescription by doctors or its distribution by drugstores except when it is specifically and intentionally used for abortion as it is in conjunction with mifepristone.

Q.  After all these changes, what is the current protocol? How late can it be used? How many visits? What sort of screening is required? How many pills over how many days? Etc.

The FDA does not spell out the steps in the prescriber agreement, but requires that, in order to prescribe the drug, the prescriber certify their ability to assess the duration of the pregnancy and diagnose ectopic pregnancies.  This appears to presume some sort of interview or screening of, or at least the filling out of some questionnaire by the patient that must be done prior to the health care provider’s writing of the prescription. 

The form filled out by the patient directs the healthcare provider to “Counsel the patient on the risks of mifepristone” and has the doctor and patient sign and date the agreement which details that mifepristone will be taken on Day 1 and the misoprostol tablets will be taken 24 to 48 hours after the mifepristone. 

That signed patient form documents that the prescriber has told the patient (at least in general terms), about the risks of “heavy bleeding” or “infection” and that the patient knows to contact the “clinic/office/provider” right away in the case of a fever of 100.4° F lasting more than four hours, heavy bleeding, severe abdominal pain or other gastrointestinal issues. The form also notes that the healthcare provider is to have told the patient who to contact in the event of an emergency if the prescriber cannot be reached.

Patients are told to follow up with the provider 7 to 14 days later to determine whether the chemical abortion has been completed and that they are well.

Patients are cautioned that the pills do not work for 2-7% of the women who take them and are told to talk to their provider about a surgical procedure to “end my pregnancy” if it still continues.

There are therefore no “required visits” in this new protocol. It’s implied that there are at least two encounters between the patient and the prescriber: one to screen and counsel the patient and arrange delivery the pills, the second to confirm whether or not abortion is complete. The official mifepristone label indicates that dosages are one 200mg pill of mifepristone, taken orally, followed at least 24 hours later by four 200 mcg pills of misoprostol, taken buccally (in the pouch between cheek and gum).

It is unclear whether this is made clear to the patient.  Dosages and administration for misoprostol are not specified in either the prescriber or patient agreements. The abortion industry has been known to tinker with these in the past, controversially suggesting vaginal self-administration of the misoprostol, for example.

While prescribers would have access to this material as part of the FDA approved label, what sort of additional instructions are included in the packages given to patients who have these pills delivered by mail is unclear.

Q. Isn’t this more dangerous?

By the FDA’s own criteria, it would certainly seem so. 

The FDA imposed its REMS [Risk Evaluation and Mitigation Strategy] regulations specifically because it felt certain conditions needed to be met to increase the likelihood of these drug’s safe use. Two of the things on which they have consistently concentrated throughout every new iteration of their regulations and prescriber agreements have been the necessity of the prescriber’s ability to determine the gestational date of the pregnancy and his or her ability to diagnose ectopic pregnancy.

The pills “effectiveness” drops the farther along the pregnancy is.  And with that drop in effectiveness, the risks of failure and complications like hemorrhage or infection increase.

The problem with an undetected ectopic pregnancy is that the signs of a potentially deadly rupture look an awful lot like the normal expected side effects of a chemical abortion. In both cases, women have painful cramps and bleeding.  If doctor and patient both just assume these are part of the abortion and simply wait for the process to play itself out, she could easily bleed to death or at least suffer serious damage to her reproductive system if an ectopic rupture is the actual cause of these symptoms.

When the FDA required at least one visit to the abortionist’s office, there was a presumption that some part of the screening or interview would be done in person. This might entail a physical exam or ideally, an ultrasound, to more precisely gauge the gestational age or to determine whether or not the child had implanted in the uterus.

Now that patient and prescriber are no longer required to actually meet in person, it is unclear how thorough this screening will be.  Certainly, an online questionnaire asking that a patient recall the date of her last menstrual period will be nowhere near as reliable or precise as an ultrasound conducted and read by a professional at a medical office.

Likewise for a verbal query as to whether or not a patient had experienced early signs of an ectopic pregnancy. Even granting that this could catch some instances, the fact that these are common (occurring in 1-2% of pregnancies) and often do not manifest until later in the first trimester mean that a fair number are likely to be missed in the absence of a professional ultrasound examination.

If the FDA is right about the issues raised in its REMS, the number and severity of complications associated with mifepristone and misoprostol are likely to soar under this new looser protocol.

Editor’s note. In the final part of our series, Dr. O’Bannon addresses whether these changes are enough to satisfy the abortion industry and how far the Biden administration means to go in pushing for the availability of these pills in states with laws against them.

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