Today, Congressman Bob Latta (R-OH5) and Senator Cindy Hyde-Smith (R-MS), with 114 colleagues from the U.S. House of Representatives and the U.S. Senate, today sent the U.S. Food and Drug Administration (FDA) a letter recommending against further weakening of the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, a chemical abortion drug.
The signed bicameral letter can be found here. An excerpt of the letter is below:
… Mifepristone, first approved in the United States in 2000, is the first part of a two-drug chemical abortion process. It blocks progesterone, a hormone that nurtures the developing child throughout the pregnancy. A second medication, misoprostol, is consumed to force the uterus to contract and expel the unborn baby. Taking mifepristone to induce a chemical abortion is not a simple process. It is a multi-day progression of bleeding, cramping, and contracting that, according to the Mifeprex ® medication guide may take up to 30 days to complete.
In addition to the loss of the unborn child, mifepristone presents serious health risks to the mother, including “serious and sometimes fatal infections” and “prolonged, heavy bleeding”. For that reason, the FDA put in place a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, indicating it is a medication with serious safety concerns. Currently, the REMS for mifepristone requires it to only be dispensed by a certified prescriber in a clinic, medical office or hospital, and requires women to be informed of the potential complications associated with taking the drug. Prescribers must also be able to diagnose an ectopic pregnancy (pregnancy outside the womb) and provide surgical intervention if necessary. If the chemical abortion drug is taken with an undiagnosed ectopic pregnancy, it can kill the woman, or at minimum require invasive, life changing surgery. …
The FDA should not remove or weaken the existing REMS on mifepristone when the insufficient data available suggests that mifepristone endangers women’s health. Requests to remove the in-person requirements for chemical abortion look the other way on women’s health and scientific data for the sake of advancing a political agenda. Recognizing and addressing the need for comprehensive data on any health risks associated with mifepristone should be a bipartisan concern. Instead of making an uninformed decision to remove the REMS, we urge the FDA to mandate collecting complete, accurate information on all adverse events related to the drug.
Although there are many disagreements about the ethics of abortion, there must be total agreement that pregnant women deserve the highest standard of medical care. As stated above, the FDA’s medical data surrounding mifepristone is scant. However, what we do know is alarming. It shows that significant morbidity and mortality have occurred following the use of mifepristone. Allowing this drug to be available without medical supervision will have dire consequences for women and children.
Latta and Hyde-Smith earlier this year introduced companion legislation, the Support and Value Expectant (SAVE) Moms and Babies Act of 2021 (HR.554 and S.78), to prevent labeling changes for already-approved abortion drugs; prevent providers from dispensing these drugs remotely, by mail, or via tele-medicine; and prevent FDA approval of new chemical abortion drugs.
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