NRL News

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)

by | Apr 13, 2023

Part four

By Randall K. O’Bannon, Ph.D., National Right to Life Director of Education & Research

Editor’s note. This is the fourth in a series by Dr. O’Bannon in which he debunks seven of the many, many myths about how and why the FDA approved and managed Mifepristone. On Monday he addressed Myths 1 & 2.  On Tuesday he analyzed Myths 3 & 4. On Wednesday, Dr. O’Bannon looked at Myth 5.

MYTH 6: If the FDA approval for Mifeprex is disallowed, the availability and use of mifepristone and misoprostol for therapeutic purposes may be negatively affected.

Reality: A decision to nullify the FDA’s 2000 approval and/or any subsequent modifications made to regulations on the distribution of Mifeprex or its generic equivalent should have no bearing on any of the therapeutic, non-abortifacient uses of these drugs.

At this point, the full extent of the judge’s decision and the ultimate outcome of the appeals process is unknown, but even a complete negation of the FDA’s 2000 approval of the abortion pill Mifeprex is not expected to affect the availability and use of either mifepristone or its accompanying prostaglandin misoprostol for their approved, non-abortifacient uses.

It is true that mifepristone was originally developed and approved as an abortifacient. The sole reason that the original sponsor filed the application with the FDA and sought and obtained the agency’s approval was for use as an abortifacient, to subvert the normal pregnancy process and end the life of a developing child.

Mifepristone does this as a progesterone blocker, chemically getting in the way of the body’s normal hormonal signal that directs the woman’s body to provide nutrients and build a protective “cocoon” around the child who is safely implanted in the mother’s uterine wall.

If the FDA’s approval of Mifeprex is overturned, or if additional regulations are imposed or reimposed upon mifepristone’s use as an abortifacient, it will affect its use for this purpose and this purpose alone.

Other medical uses of mifepristone

As an antiglucocorticoid, mifepristone not only blocks progesterone, but also blocks cortisol, the body’s so-called “stress hormone.” This makes it an effective treatment for Cushing’s syndrome, where the body overproduces cortisol, affecting the body’s ability to regulate metabolism, blood sugar levels, blood pressure, fluid balance, and its response to stress.  In 2012, researchers with a company called Corcept sought and received a separate FDA approval to produce mifepristone as a treatment for Cushing’s syndrome, selling the drug under the trade name Korlym.

Use as a treatment for Cushing’s syndrome should not be affected in any way by the judge’s decision. Korlym is prescribed and sold at a different price and a different dose.

For a woman seeking a chemical abortion, a standard month-long prescription for Korlym would be prohibitively expensive and would entail the delivery of dozens of pills which would not be used. A prescription of a single Korlym pill would be unnecessarily expensive and would raise questions, as it would clearly not be being prescribed as a treatment for Cushing’s syndrome, the condition for which the FDA approved that drug.

In a state where chemical abortions are not legal, this odd prescription which does not fit the drug’s standard medical profile may lead to a pharmacist’s refusal to fill the order and could give authorities reason to investigate physicians who write such prescriptions (the laws are typically written, however, so that the patient is not to be investigated or prosecuted for seeking or using the pills to abort her child).

Misoprostol still available to prevent ulcers

The situation is somewhat similar for misoprostol, the prostaglandin that has been used for more than twenty years in conjunction with Mifeprex (or its generic counterpart mifepristone). The protocol that the FDA approved for Mifeprex specified that misoprostol, a drug already separately approved to fight ulcers, be given a day or so after the mifepristone essentially starved or suffocated the child in order to stimulate powerful contractions to expel the child’s dead or dying corpse.

Significantly, though, in authorizing misoprostol’s use with mifepristone, the FDA did not alter the label for Cytotec, the brand name under which the FDA originally approved misoprostol for G.D. Searle in 1988. Searle developed and submitted Cytotec to the FDA as an anti-ulcer medication for people who have to take a lot of NSAIDs (non-steroidal anti-inflammatory drugs); it has never sought or endorsed the use misoprostol as an abortifacient or in use with another abortifacient like mifepristone.

It is still prescribed and used as an anti-ulcer medication today.

However, because of its chemical properties and because it can initiate powerful uterine contractions and expulsion of the child from the uterus on its own, it has in recent years often been used as an abortifacient in its own right, particularly in countries where abortion or other chemical abortifacients are not legal, or in places where chemical abortifacients like mifepristone are either considerably more expensive or harder to find. 

It is generally not considered the preferred method because it is not as effective as an abortifacient as the mifepristone-misoprostol combination and can come with more unpleasant side effects (N.T. Ngoc, Contraception, May 2011).

Again, this is not a use that the original manufacturer endorses nor is it a use recognized on the drug’s official label.

As a matter of fact, the FDA has given Cytotec (misoprostol) its “Category X” designation, reserved for drugs where “Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.” 

The point of all this is that misoprostol is a drug approved for a legitimate medical purpose and that the FDA has no reason to disallow that original approval or to revise its current label.

Could a rogue abortionist still prescribe misoprostol off-label as an abortifacient? Yes, but if he or she does so in a state where chemical abortions are prohibited or unborn children are legally protected, and that intent is clear in the prescription, the pharmacy can and should refuse to fill that prescription and the prescriber could be prosecuted for violating the law.

Allowed for legitimate medical purposes

The intent of medicine—and of the health care personnel and concerned citizens raising these issues with the FDA’s approval and handling of mifepristone—is the promotion and preservation of human life and public health. Most people are convinced that this should be the FDA’s aim as well. 

The use of mifepristone, misoprostol or any other drugs for the purpose of promoting, protecting, or preserving of human life and health are not a problem. Their use to take innocent human lives, and to do so with the government’s imprimatur, is a problem. 

The answer lies not in prohibiting the use of these drugs for legitimate therapeutic purposes, but in rescinding their official approval for use as abortifacients.

This won’t solve all of the problems with the misuse of these drugs. But at least it will put the government back on the side of protecting the public health of its residents.

Categories: Abortion Pill