U.S. Representative Robert Aderholt, R-Ala., and U.S. Representative Barry Moore, R-Ala., criticized the Food and Drug Administration on Wednesday for approving a generic version of abortion drug, mifepristone.
Mifepristone is a drug prescribed in combination with misoprostol to terminate a pregnancy within the first ten weeks of gestation. The medication has been FDA-approved for 25 years.
The representatives released statements opposing the approval of a generic option for the drug, announced by the FDA on September 2, alleging the drug puts women’s lives at risk with dangerous side effects.
Statements condemning the approval were released by an additional 22 members of the U.S. House Values Action Team, which Aderholt chairs.
“The FDA’s approval of a new generic version of the abortion pill, mifepristone, endangers women’s health and disregards the value of life. Previously approved versions of this drug demonstrated dangerous side effects including life-threatening sepsis, infection and hemorrhaging,” the representative wrote.
Aderholt and Moore also urged U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. to ensure the report he directed the FDA to conduct on mifepristone’s safety last month highlights alleged harmful side effects of the medication.
“By approving another generic iteration of this pill while a safety review is ongoing, the FDA risks undermining women’s health and safety across the United States. The agency must stay true to its mission of protecting public health and ensuring the safety of drugs,” Aderholt wrote. “As always, I remain committed to working with my colleagues in Congress and across the government to better protect the lives of women and the unborn from these dangerous drugs.”
Kennedy’s September 24 announcement that the FDA would review safety protocols surrounding mifepristone use followed a letter sent in August by 22 Republican attorneys general, including Alabama Attorney General Steve Marshall.
“I urge HHS to quickly expedite its thorough investigation into the harmful effects and adverse events associated with mifepristone, as already promised by Secretary Kennedy. We must protect women from the dangers and serious risks of chemical abortion,” he continued.
Moore called for HHS to “move quickly and keep its word by conducting a full and transparent investigation into the harmful effects and adverse events linked to mifepristone, as Secretary Kennedy has already promised.”
“This dangerous drug has been marketed as ‘safe,’ yet it has left a trail of pain, complications, and even death,” he added.
Moore went on to emphasize the opposition to the drug’s basis on religious and ethical grounds.
“Beyond the physical risks, we must also remember what’s at stake spiritually and morally. Every dose of mifepristone is designed to end an innocent human life, a life made in the image of God,” the representative wrote. “As a nation, we cannot turn a blind eye to both the harm done to mothers and the tragic loss of children. I will continue to fight for the truth, for accountability, and most importantly, for the sanctity of life.”
Aderholt pointed to the FDA’s fact sheet on mifepristone, which reports that 36 women have died and 97 have had ectopic pregnancies following their use of the drug.
“The fatal cases are included regardless of causal attribution to mifepristone,” the FDA wrote of the deaths listed on the fact sheet.
Among fatal cases reported by the FDA, 13 occurred due to sepsis, one due to septic shock from a flesh-eating bacterial infection, one due to a “delayed onset toxic shock-like syndrome,” one due to hemorrhaging, one due to Thromboembolism, one due to a probable anaphylactic medication reaction, one caused by severe pulmonary emphysema and one due to “sepsis with multiple complications possibly secondary to toxic shock syndrome 82 days after mifepristone.” Two of the deaths’ causes were undetermined.
Also among deaths included in the 32 fatalities were two homicides, one suspected homicide, seven deaths due to forms of drug intoxication and overdoses and two suicides.
“Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program,” the FDA wrote in its overview of mifepristone’s safety and serious adverse effects.
“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,” the agency also wrote.
Aderholt also cited a study conducted by conservative think tank, the Ethics and Public Policy Center, which argues that instances of hospitalizations and deaths as a result of mifepristone use have been underreported.
EPPC’s report on mifepristone was also cited by the letter sent by Republican attorneys general urging HHS to initiate an investigation of the drug.
The report was authored by the organization’s president and director of data analysis. It has not been peer-reviewed or published in a medical journal.
The methodologies of EPPC’s study have also come under fire from representatives of the American College of Obstetricians and Gynecologists, alongside women’s health workers and health policy research nonprofit, the Kaiser Family Foundation.
“Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective,” said 2024 ACOG President Stella Dantas.
University of California-San Francisco associate professor of obstetrics, gynecology and reproductive sciences Lauren Ralph also criticized the paper for associating mifepristone use with ectopic pregnancies and for reporting that 40,960 emergency room visits taken by women after taking an abortion medication were evidence of mifepristone’s adverse effects.
“Ectopic pregnancy is not caused by a medication abortion, but rather is something that occurs in pregnancy. Abortion medications do not create harm if taken by someone with an ectopic pregnancy,” Ralph wrote.
“Prior research indicates that many people go to the emergency department for follow-up care post-abortion, but this care is often to ensure abortion completion or get reassurance about symptoms rather than for treatment of an adverse event,” she added.
KFF cited the FDA’s report on its ten clinical trials conducted on mifepristone, in which over 30,000 patients were administered the drug and less than 0.5 percent experienced adverse effects. The organization also cited additional peer-reviewed studies, including one published by the medical journal, Nature Medicine and a report conducted by multiple U.S. and U.K. universities, both of which reported similar rates of adverse impacts.
