For abortion pills, the FDA goes soft on safety | WORLD
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For abortion pills, the FDA goes soft on safety

New rule proves the Biden administration cares more about abortion than women’s health


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For abortion pills, the FDA goes soft on safety
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The Biden administration recently revealed the lengths to which it’s willing to go to aid and abet the abortion lobby. The administration will push so far, it seems, that it has not only broken the law (as these pair of congressional letters detail), but also endangered the lives of women and children.

On Jan. 3, the Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services (HHS), quietly updated the language on its website to reflect a major regulatory change regarding abortion pill mifepristone, a drug that was originally rushed to market after the standard safety requirements for certifying drugs were circumvented. The abortion pill will now be legal to sell at all qualified retail pharmacies in the United States, both in store and by mail. What the Biden administration apparently doesn’t know, however, is that the change contradicts its own safety regulations and recommendations for the drug.

Mifepristone, also called mifeprex or RU-486, is approved by the FDA for the termination of pregnancy through 49 days of gestation. Yet research shows that in a five-year period after the drug’s approval, “abortion pill-related emergency room visits increased more than 500 percent,” putting women at much greater risk than before the drug’s availability. In keeping with this research, mifepristone is associated with at least 20 deaths and 2,660 adverse events. Meanwhile, only four deaths and 350 adverse events were enough for manufacturers to yank blood pressure medication, Heparin, from the market, a debacle that had Democrats calling for the FDA commissioner’s resignation. (The FDA also admits that its adverse event system is “inadequate and significantly underestimates the adverse events from mifepristone,” meaning it’s likely the deaths and adverse events that have occurred because of the drug are much higher than reported.)

Additionally, the FDA’s safety protocols to mitigate the risks of the abortion drug were sidestepped in an attempt to rush the drug to market. According to the National Institutes of Health (NIH), another division of HHS and sister-organization to the FDA, “significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient,” and “a pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age.” The drug is deadly for women with ectopic pregnancies, and ectopic pregnancies can only be diagnosed via ultrasound. The Biden administration must simply not care about women’s lives, however, because in this newest final rule on abortion pill mifepristone, it allows women to obtain the drug without the former requirement to be seen by a physician in-person before consumption.

Another troubling effect of mifepristone is the 100 percent fatality rate it poses for women whose bodies possess certain bacteria.

Another troubling effect of mifepristone is the 100 percent fatality rate it poses for women whose bodies possess certain bacteria. For these women, the side-effects of the drug are the same as for other women—severe cramping, bleeding, nausea, vomiting—yet in five to seven days, these women have multi-system organ failure. It is reported that every woman with such bacteria present in her reproductive tract, which isn’t altogether uncommon, dies in five to seven days of ingesting mifepristone.

As a congressional committee has stated, “Any other drug associated with a 100 percent fatal septic infection that kills otherwise healthy adults within days, with no apparent window for treatment, and associated with an exponential amount of severe reactions would normally prompt an immediate withdrawal.” But we’re talking about an abortion drug, which, for the Biden administration, means all safety considerations for the woman are unimportant compared to her ability to terminate her own pregnancy.

Mifepristone has been controversial almost as long as it’s been in existence, and certainly long before the reversal of Roe was even thought possible. In 2006, the U.S. congressional committee with jurisdiction over drug safety and regulation found that the approval of mifepristone was made under “extreme political pressure from the Clinton administration,” despite the fact that there were clearly severe safety issues with the drug. Democrats continued to weaken protections for women regarding the drug during the Obama administration, and now the Biden administration has completely done away with all protections for women regarding the drug.

How can a drug be considered “medicine” if it endangers women’s lives? How can the government tout its promotion of “healthcare” if the drug it promotes not only takes one life, but could take two? At least 20 women have died from the use of mifepristone, as well as almost all infants whose mothers took the drug while pregnant. How many more must die before Democrats seriously consider the health of women to be as important as her so-called “ability to choose”?

As Congressman Mark Souder said in 2006, “To continue defending this dangerous drug in light of the mounting scientific evidence, injury, and death is to allow one’s zeal for abortion to truly distort their view about what is right for women’s health.” But then, we already knew that.


Katelyn Walls Shelton

Katelyn Walls Shelton is a Bioethics Fellow at the Paul Ramsey Institute. She is a women’s health policy consultant who previously worked to promote the well-being of women and the unborn at the U.S. Department of Health and Human Services. She graduated from Yale Divinity School and Union University and lives in Washington, D.C., with her husband, John, and their three children.

@annakateshelt


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