Project Description
Cover Story
Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)
By Randall K. O’Bannon, Ph.D.,
NRL Director of Education & Research
Editor’s Note: The following are excerpts from a much longer article, which can be read at https://www.nationalrighttolifenews.org/2023/04/addressing-many-myths-mifeprex-mifepristone/
[Readers have probably heard about the] suit brought by the Alliance for Hippocratic Medicine and other pro-life groups challenging the 2000 approval of Mifeprex (mifepristone¹), the abortion pill, by the U.S. Food and Drug Administration (FDA).
[Readers have probably seen] the press talk about 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 are 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.
[This article will address seven] popular mistakes and misunderstandings about the process. … 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.
MYTH 1: Mifeprex (mifepristone) is the kind of ordinary drug that the FDA considers every day to improve Americans’ health.
Reality: Unlike 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. …
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. …
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 baby, would 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? …
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.
Reality: The FDA approved mifepristone under a special process that allowed for accelerated approval and more limited initial testing but enabled the agency to more closely monitor and control distribution in light of identified safety risks.
Much has been made of the FDA’s use of its special Subpart H designation to authorize “accelerated approval” for Mifeprex (mifepristone), a status reserved for “new drugs for serious or life-threatening illnesses.” Given that normal pregnancy is neither a “serious” nor “life-threatening illness,” this obviously represents a misapplication of the statute, merely reinforcing that the FDA had no business considering a drug to kill babies in the first place. …
MYTH 4: Approval and modifications to the abortion pill protocol were supported by the best, most objective scientific studies.
Reality: The FDA relied too heavily on flawed studies and incomplete data from partisan abortion advocates and ignored strong scientific evidence to the contrary. …
[This section of the original article is long, and well-documented. In summary, patients that were lost from studies were ignored, relevant emergency room data was not considered, data was deficient, claims were flawed, and inconvenient truths were ignored.]
Clearly, the FDA needs to critically and objectively assess all relevant data bearing on its drug decisions rather than cherry picking only that data and those studies that support the industry’s — or administration’s — public policy agenda.
MYTH 5: Mifeprex (mifepristone) has an excellent safety record.
Reality: Mifepristone has been connected to more than two dozen maternal deaths and thousands of maternal injuries and “adverse events.” …
The truth is that these reports only represent the tip of the iceberg. These are only the cases which have been reported back to the FDA. There is reason to think that there are many, many more which the FDA never hears about.
Early on, when a woman had a problem and contacted the office of the prescriber who gave her the abortion pills, that prescriber was supposed to not only address her problem, but record her complication and pass it on to the sponsor (the distributor), who was to send this information to the FDA. In 2016, though, upon determining that it had a sufficient record to build an adequate “safety profile” of the drug, the FDA decided to drop the requirement that all serious adverse events be reported back to the agency, though it still asked that any patient deaths be reported.
There was record of a substantial number of deaths and injuries at that point, but still reason to believe that many were being missed.
As we have already pointed out in earlier sections, women experiencing problems with their chemical abortions often go to the emergency room or their own personal doctor rather than returning to the clinic or calling the prescriber who they may have met only once (if at all) and who may have counseled them to go elsewhere in the event of emergency.
If they do not return the clinic’s phone calls or answer the abortion pill provider’s emails, the prescriber will likely have no record of the woman’s crisis.
This is only compounded by the fact that many prescribers have explicitly advised women not to reveal to medical personnel in the emergency room that they have taken the abortion pill, but merely to say that they are suffering from a miscarriage. In these instances, a woman’s case would probably never be connected to the abortion pill, and she would probably end up counted as one more safe use of mifepristone.
The FDA used to direct women to take their medication guides with them to the emergency room and tell medical personnel there that they had taken the abortion pill, but the agency decided in its most recent guidance to drop that instruction from its latest REMS and Patient Guides, allowing more and more of these cases to escape being attributed to the mifepristone/ misoprostol combination. …
Nevertheless, what we do have gives us a clear picture of a drug with numerous serious risks. It is difficult, painful, and bloody for nearly everyone who takes it. When it works, it takes the life of an innocent human being. It has been connected, time and again, to hemorrhages, infections, and ruptured ectopic pregnancies. Healthy women in the prime of their lives have taken this drug and died. …
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. …
MYTH 7: Pro-Lifers are challenging the FDA’s legitimate authority and expertise.
Reality: Pro-Lifers are trying to restore the FDA’s authority and legitimacy by getting the agency back to its mission of bringing lifesaving, not life taking, drugs to the market. …
The FDA needs to recommit itself to the health and safety of Americans.
Even if the agency won’t reconsider its approval of mifepristone on the grounds of what it does to the unborn child, the FDA still has got to have and enforce higher safety standards than that for the sake of their mothers. …
Until this approval is rescinded, and the agency gets out of the business of killing patients, the FDA will continue to flounder and compromise its mission and authority.
¹[When this article references] the “abortion pill,” [it is] 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 [it] specifically speaks about just the first drug, assume [it is referencing] the mifepristone-misoprostol combination when [it says] “abortion pill.”