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

Part Five

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

Editor’s note. This is the fifth and final installment 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. On Thursday he critiqued Myth 6.

MYTH7: 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.

With the FDA’s dealings with mifepristone reaching back more than thirty years, we now have enough of a record to see a pattern. 

A Democrat administration takes charge and, with strong backing by the abortion industry and its media allies, pushes the FDA to approve mifepristone or otherwise loosen regulations and expand its distribution.

After going through its various committees and panel reviews, giving abortion advocates an opportunity to conduct the necessary studies and present their findings, the FDA generally accedes to those requests, but usually with some sort of caveat or condition to show that they still have some reservations about the drug being widely available and used in the marketplace without any control or oversight.

The aim of abortion pill advocates is clearly to have the drug available over the counter, something women can order online and have delivered to their homes, without any sort of government or unwanted medical interference – the “no-test” self-managed abortion.*

Under enormous political pressure, the FDA has gradually moved their way, granting approval, modifying the protocol, loosening certification requirements, etc. Perhaps to its credit, the FDA seemed to do this grudgingly—requiring post-marketing studies, establishing a rigorous protocol, a strong certification process, and, at least at the beginning, heavily controlled distribution —but these rules and conditions have been watered down as the years have passed.

The FDA might argue that this has been in response to new data, to years of subsequent experience with the drug showing many of these controls unnecessary, but, as we have shown, the FDA has been far too selective in the studies they have used and not nearly critical enough with their claims and results.

Their own data from official FDA“Post Marketing Adverse Events” summaries for mifepristone show more than two dozen known deaths of American mifepristone patients (and an additional 13 reported deaths from other countries) and thousands of other complications or crises such as infections, hemorrhage, transfusions, ectopic pregnancy, etc. This is not the record of safe, effective, life-saving medication.

Clouding the issue of causality

Dutifully offering mifepristone sponsors and supporters a defense, the FDA reminds people that they are not claiming a causal relationship between these drugs and these negative sequelae, but this is disingenuous.

No one believes that the young women who died of deadly clostridial infections contracted the bacteria from the pills; women likely introduced this common bacterium into their bodies by vaginally self-administering misoprostol into their reproductive tract, where the anaerobic bacteria thrived in the blood rich environment of a bleeding, aborting uterus.

No one is saying that mifepristone causes ectopic pregnancy, but the expectation of significant bleeding and cramping that accompanies the standard chemical abortion has caused both patients and doctors to miss signs of a rupturing ectopic pregnancy, which can prove deadly if unrecognized and untreated.

It is much more difficult to say that there is no connection between mifepristone and misoprostol and bleeding. These drugs work by initiating bleeding and cramping, chemically triggering the menstruation process as if there were not a baby present. The amount of pain and bleeding may vary from woman to woman, but more may be expected the farther a woman is along, which is why determination of gestational age is such an important part of screening.

If the FDA allows prescribers and patients to forego the sort of in-person counseling and screening that ensures a woman knows how to properly administer these drugs and detects conditions and gestations where the drugs will not be effective, more of these “adverse events” are to be expected, regardless of the “causal” analysis.

Giving the abortion industry more control over the distribution of mifepristone is not a good thing. In advocating the “no-test” self-managed protocol, industry leaders have made clear their willingness to accept or at least tolerate a lot of women misestimating their child’s gestational age, a great number of missed ectopic pregnancies, and the possibility that a woman might unintentionally pronounce a death sentence on the children of any future pregnancies by failing to be tested and treated for Rh factor.

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.

It is clear that public health matters to the FDA and that they jealously guard their institutional integrity. But mifepristone and its politically powerful promoters have forced the FDA into areas and issues the agency is not designed to handle and ill equipped to navigate or manage.

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.

* Elizabeth Raymond, Daniel Grossman, Ushma Upadhyay, Mitchell Creinin, et al., “Commentary: No-test medication abortion: A sample protocol for increasing access during a pandemic and beyond,” Contraception, June, 2020.