Today, Live Action and a coalition of pro-life groups including the Susan B. Anthony List, Students for Life for America, and the American Association of Pro-Life Obstetricians and Gynecologists, sent a letter to the Food and Drug Administration (FDA) calling on Commissioner Stephen Hahn to remove abortion pill Mifeprex (mifepristone) and its approved generics from the U.S. market. The letter follows District Judge Theodore Chuang’s July 13 decision to suspend the FDA’s safety protocol on the drug during COVID-19, ruling that it is an “undue burden” to require women seeking the drug during the pandemic to obtain it at an in-person visit.
The coalition letter, which points out that abortion pill complication rates are four times higher than those of first trimester surgical abortions and which calls the drug an “imminent hazard to the public health,” was also signed by the American College of Pediatricians, Samaritan’s Purse, Heartbeat International, Heritage Action, and others.
The deadly drug is an imminent hazard to public health and poses a significant threat to the lives of women & children.
— Live Action (@LiveAction) July 28, 2020
Currently suspended under COVID-19, the FDA’s Risk Evaluation and Mitigation Strategy (REMS) requires prescribers of the abortion pill to be specially certified and qualified to “assess the duration of pregnancy accurately,” to “diagnose ectopic pregnancies,” and to “provide surgical intervention in cases of incomplete abortion or severe bleeding” or to have arranged plans for such care with others. REMS explicitly states that the abortion pill is to be dispensed “only in clinics, medical offices and hospitals by or under the supervision of a certified prescriber” and “not distributed to or dispensed through retail pharmacies or other settings….”
Foregoing testing (for pregnancy itself and for the mother’s Rh factor) and in-person assessment (ruling out ectopic pregnancy) puts women at risk. Judge Chuang’s decision now provides a loophole for abortion businesses to continue exploiting the coronavirus pandemic to push dangerous do-it-yourself abortions.
Live Action’s letter highlights the 3.7 million children killed by the abortion pill since the FDA approved it in 2000, as well as the 24 known maternal deaths and 4,000 adverse events from the drug. The letter urges Commissioner Hahn to “fight back” against the abortion industry’s attempt to profit from a global pandemic:
…We urge you to pull the abortion pill from the US market immediately and declare it an imminent hazard to the public health under 21 CFR § 2.5. We also encourage your continued efforts to stop the illegal trafficking of black market abortion pills into US commerce, and to fight back against the abortion industry’s radical push to overturn REMS in the courts.
Editor’s Note, 4/18/21: The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal.
The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is here.
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