Last week, Republican members of the Florida delegation on Capitol Hill joined U.S. Sen. Cindy Hyde-Smith, R-Miss., and more than 100 GOP colleagues from the U.S. Senate and U.S. House of Representatives to send a bicameral letter to the U.S. Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock recommending against easing restrictions on mail delivery of mifepristone, a chemical abortion drug, during the pandemic.
The agency plans to waive enforcement of Risk Evaluation and Mitigation Strategy (REMS) protections that apply to mifepristone, making chemical abortions more available. These measures were put in place decades ago to protect women from the negative health consequences of self-administering abortion drugs at home and to ensure they understand the full risks of chemical abortions.
Florida Republican U.S. Sens. Marco Rubio and Rick Scott and U.S. Reps. Gus Bilirakis, Neal Dunn, Brian Mast, Bill Posey, John Rutherford and Michael Waltz signed the letter.
The text of the letter is below.
Dear Acting Commissioner Woodcock:
We write to express our concerns with the recent action by the Food and Drug Administration (FDA) not to enforce the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone for the remainder of the COVID-19 public health emergency. Proponents of removing the REMS ignore both the extremely limited data available from the FDA regarding the potential health impacts on women and the international data indicating that one in five women who undergo chemical abortions are likely to experience adverse events. To protect the health of women, the REMS should be strictly enforced, both during the public health emergency and after it ends.
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.
In the years since FDA approval, Mifeprex has been used by over 4 million women in the United States. The most complete analysis of the adverse events received by the FDA has been published most recently in 2021. The drug company that manufactures Mifeprex acknowledges that 2-7% of women will need a follow up surgical procedure, and a systematic review by abortion advocacy researchers similarly confirmed this to be 5% of women needing a follow-up surgical completion.
The most widely accepted definition for the frequency of drug complications is given by the Council for International Organizations of Medical Sciences (CIOMS), an international, non-governmental, non-profit organization established jointly by World Health Organization and United Nations Educational, Scientific and Cultural Organization in 1949. The CIOMS training manual on medicine safety states that “adverse drug reactions” are “very common” if they occur in over 10% of cases and “common (frequent)” if they occur between 1 and 10% of the time.
Published studies show that serious complications from drug-induced abortions are in the range of 3-5%, if not greater. The aforementioned Australian study, for example, found that 3.3% of patients who used mifepristone in the first trimester required emergency hospital treatment. And the study from Finland found that 15.6% of women experienced hemorrhage after a medical abortion, that 6.7% of women had incomplete abortions, and that 5.9% required surgery to complete the abortion. Using the CIOMS criteria, this means complications from medical abortions are “common” or “frequent.”
Unfortunately, FDA data on the potential health risks that mifepristone poses is limited. Adverse event reporting is voluntary and sporadic. Over 95% of the adverse events reported to the FDA came from the manufacturer, which would seemingly have no incentive to accurately report complications. Even worse, since 2016, the only data that must be reported to the FDA is known deaths. When looking at the data published by the FDA, we must acknowledge that this number of adverse events is clearly a gross underestimation of the actual number of complications occurring in American women, as the expected complication rate of approximately 3-8% established in the medical literature would yield 120,000 (4 million x 0.03) to 320,000 (4 million x 0.08) women with severe, life threatening and fatal adverse events.
However, some conclusions can draw from the data made available to FDA. Of the adverse events reported to the FDA:
Over 20% were life threatening or resulted in death.
70.16% required follow up surgery, including total hysterectomy.
Abortion providers did not handle most of their complications, but rather left the women to find care at the emergency room on their own.
Many of the adverse events reported to the FDA were due to ectopic pregnancies; one resulted in the death of the mother. According to the Centers for Disease Control (CDC), ectopic pregnancy accounts for 2% of all reported pregnancies. Half of those women do not have any known risk factors. Prescribers must exclude the possibility of an ectopic pregnancy before prescribing the chemical abortion regimen, which can only be done using an ultrasound.
While the limited FDA data available suggests the risk that mifepristone presents to women’s health, data from other countries is more reliable and offers a much clearer picture of the danger. For example, in 2009, the Finnish study of 42,619 women found that women who have had chemical abortions are almost four times more likely (20.0% compared with 5.6%) to experience adverse events. The study covered “almost all abortions performed in Finland during the years 2000-2006.”
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.
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