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

by | Apr 10, 2023

Part One

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

Since this article was originally written, Matthew Kacsmaryk, a judge from the United States District Court for the Northern District of Texas has ruled on a suit brought by the Alliance for Hippocratic Medicine and other pro-life groups challenging the 2000 approval of Mifeprex (mifepristone*), the abortion pill, by the U.S. Food and Drug Administration (FDA). He said the FDA’s approval and subsequent actions regarding mifepristone were contrary to its own regulations and ordering the agency to withdraw its marketing approval after seven days.

Not surprisingly, the press has reacted by claiming how unwarranted the lawsuit was, that there was nothing at all wrong with the FDA’s original approval, that the drug has been looked at again and again and has proven absolutely safe and effective in more than twenty years of use.

But what were the merits of the case? What are the real issues involved? Many people are hearing about this story for the first time, suddenly recognizing that the Supreme Court’s Dobbs decision overturning Roe means that states now possess the legal capacity to outlaw these baby killing drugs. They know little or nothing about these pills except that they’re supposed to be a quick, safe, and simple way to have an abortion.

They aren’t, of course. The abortions brought on by these pills are messy, painful, bloody, and dangerous. They have taken the lives of millions of innocent unborn children and put the lives and health of so many of their mothers at risk. Rather than admit and respond to these risks, abortion pill advocates have pushed the FDA to dial back safety restrictions imposed on mifepristone so that they can increase the number of prescribers and expand the market.

Given the many voices, interests, and claims of expertise, separating the truth from the myth here can be difficult, even for a journalist. In the interest of bringing some clarity to the issue, National Right to Life offers this assessment of some of the more common claims being made about the abortion pill mifepristone and how the FDA has handled its approval and modifications made to mifepristone’s protocol.

Over the next several days, we’ll be addressing the following popular mistakes and misunderstandings about the process:

MYTH 1: Mifeprex (mifepristone) is the kind of ordinary drug that the FDA considers every day to improve Americans’ health. 

MYTH 2: The FDA are experts at drug evaluation and applied the same rigorous assessment standards to Mifeprex (mifepristone) that it uses for all other drugs.

MYTH 3: After going through the same rigorous testing and evaluative processes the agency requires of all other drugs, the FDA gave Mifeprex (mifepristone) its full and unqualified approval.

MYTH 4: Approval and modifications to the abortion pill protocol were supported by the best, most objective scientific studies.

MYTH 5: Mifeprex (mifepristone) has an excellent safety record.

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.

MYTH 7: Pro-Lifers are challenging the FDA’s legitimate authority and expertise.

In the end, it should become clear that the FDA’s approval of mifepristone was no ordinary approval for any ordinary drug, and that while the abortion industry has been successful at convincing the FDA to reduce restrictions on the distribution and prescription of the drug, it has done little to mitigate the risks and dangers associated with it.

Mifepristone was and is a drug that kills unborn children, risks the lives and health of their mothers, and never should have been approved by the FDA.

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MYTH 1: Mifeprex (mifepristone) is the kind of ordinary drug that the FDA considers every day to improve Americans’ health. 

RealityUnlike other drugs the FDA considers to enhance or improve public health, mifepristone was a drug designed and developed to take human lives, which is something in which a public health agency should not be involved.

The FDA has, as a matter of principle, refused to regulate drugs used by states in lethal injections, determining that the safety or efficacy of those kind of drugs is beyond its purview. It should have applied that same logic to mifepristone and refused to consider an application of the abortion pill.

The FDA should never have asked for or taken an application for such a drug, no matter the political pressure, because it is fundamentally inconsistent with the agency’s purpose and mission.

The FDA’s own mission statement begins by saying that “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices…”

The FDA’s commitment to public health, to ensuring the safety, efficacy, and security of drugs used by the American public clearly means a commitment to the authorization of drugs that cure, that heal, that treat various ailments, illnesses, or conditions, not to those which take human life or put it at unnecessary risk.

Unless pregnancy is redefined as a disease and the health and well-being of the unborn child is somehow determined not to be a part of public health, the FDA has no business considering, much less approving, a drug explicitly developed, intended, or sold for the killing of innocent human beings.

Pregnancy is NOT a disease, but is, in the vast majority of cases, a natural, normal, perfectly healthy condition experienced by millions of women each year. It is not an ailment or condition for which medical science seeks a cure.

If this had been one of those rare instances like ectopic pregnancy where a continued pregnancy posed a risk to the life or health of the mother, the FDA could have considered mifepristone for this application, weighing the benefits versus the risks of this treatment against alternatives, but this was not the purpose for which the sponsor sought approval (and mifepristone does not work in circumstances of ectopic pregnancy anyway).

No, the only purpose for which the sponsor sought FDA’s approval was for the purpose of aborting the healthy children of healthy mothers who were in the first trimesters of healthy pregnancies.

One must also ask how the termination of human life is consistent with the FDA’s commitment to “public health.” Either “public health” includes the human child carried in the mother’s womb or it doesn’t. One can’t have it both ways. It doesn’t make sense for the FDA to consider or approve drugs and treatments for continuation of pregnancy and the preservation of an unborn child’s life on the one hand, while at the same time authorizing drugs that would result in the death of a child of the same age and health on the other.

The value of human life, the child’s status as a patient, the agency’s commitment to their “public health,” cannot rest simply on whether the child is wanted or not.

The only way that the FDA could justify considering, much less approving, an application for a drug developed for killing human children was ignoring its own mandate, by going against the basic principles of medicine, by ignoring the basic facts of biology, and by giving politics priority over public health.

MYTH 2: The FDA’s scientists are experts at drug evaluation and applied the same rigorous assessment standards to Mifeprex (mifepristone) that it uses for all other drugs. 

Reality: The FDA’s normal evaluative process was ill-suited to assess a drug intended to kill rather than cure patients.

If you were evaluating a drug to treat ulcers, or cancer, or even a critical hormone imbalance, evidence that it triggers considerable pain, copious bleeding, or that for pregnant women it usually leads to loss of the babywould all be taken as clear signs that the drug was not safe, had compromised effectiveness, and was certainly not appropriate for market approval.

Only by flipping the approval process on its head and making the negative features the desired application rather than disqualifying side effects can any sort of evaluation proceed, even though the process is clearly tainted and contorted and quickly reveals itself as a tool ill-fitted for the task.

What do “safety” and “efficacy” mean when killing babies is the aim?

How do we “safely” kill a child?  Are we saying that a drug that kills more babies is more “effective?” What sort of cost-benefit analysis is this?

As Mary Jo O’Sullivan, one of the members of the FDA’s original Reproductive Health Drugs Advisory Committee asked her fellow members, “Benefit to whom?” O’Sullivan was willing to grant “if you are talking about a woman, it may be a benefit to her, but it is certainly no benefit to her baby whatever.” (FDA Committee Transcript of Mifepristone Hearing, July 19, 1996)

That these were the wrong sort of questions was only part of the problem. How high a percentage of dead babies do you have to have to call an abortion pill “effective?”  77%? 83%? 92%?  How do you decide that pills which work by inducing horrible bleeding and cramping are “safe?” Is it enough that a woman survives the ordeal?

It is one thing if you are calculating the costs of dangerous or debilitating side effects against the possible benefit of restoring the health or functioning of an extremely sick or suffering person and another entirely if you are talking of how much risk you can impose on a healthy mother in the middle of a healthy pregnancy to force her body to abort her child.

What do you do if a few women die, if they bleed to death, if they come down with rare, deadly infections, if women and doctors miss signs of a rupturing ectopic pregnancy because they’re expecting the pain and the bleeding that accompanies every chemical abortion?

These certainly don’t appear to be the signature of a safe drug, yet the record clearly shows that these are the sort of things mifepristone patients can expect.


*Throughout this series, when we talk about the “abortion pill,” we will be talking about Mifeprex (mifepristone), the drug the FDA actually approved for abortion in September of 2000. But the abortion pill regimen, as approved, actually involves at least two drugs – mifepristone, which blocks the action of the pregnancy hormone progesterone responsible for managing and maintaining life support for the early human embryo, and misoprostol, a prostaglandin taken a day or so later, which stimulates powerful uterine contractions to expel the dead or dying baby. Unless we are specifically speaking about just the first drug, assume we are talking about the mifepristone-misoprostol combination when we say “abortion pill.”

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