The FDA will finally launch a proper investigation of the dangerous abortion pill, which has killed multiple women, injured hundreds of thousands and killed millions of babies.
The Food and Drug Administration has launched a safety study of mifepristone, the primary drug used in dangerous chemical abortions. The review comes as pro-life advocates and Republican lawmakers press for new restrictions on the pill’s distribution and use.
The study, which is expected to take about six months with results anticipated after the midterm elections, represents a significant victory for pro-life groups who have grown impatient with prior administration assurances that no further review was needed.
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The FDA’s website currently maintains that mifepristone, approved decades ago, remains safe when used as directed. But pro-life advocates point to mounting evidence of widespread harm, including a new analysis showing the pill has injured more than 95,000 women.
A study by the Ethics & Public Policy Center (EPPC), based on an examination of more than 865,000 insurance claims for mifepristone patients, found a serious adverse-event rate of approximately 11 percent — far higher than the FDA’s long-standing claim of less than 0.5 percent based on limited clinical trials.
The EPPC data, filed in an amicus brief in the ongoing lawsuit State of Louisiana v. FDA, showed the rate of serious complications rose from 10.15 percent to 11.5 percent after the FDA eliminated the in-person dispensing requirement.
“The rate of serious adverse events was significantly higher when the FDA’s in-person dispensing requirement was not in effect,” the EPPC brief stated. “Indeed, the data indicates that a serious adverse event was from 1.53 to 2.33 times as likely with remote dispensing as with in-person dispensing.”
The analysis also revealed that the incidence of ectopic pregnancies — a life-threatening condition the abortion pill does not treat — was three to six times higher when the in-person visit requirement was dropped.
Without an ultrasound or physical exam, women with ectopic pregnancies may mistake symptoms such as pain, cramping and bleeding for normal side effects of the abortion drug, potentially delaying emergency care. If such women take the abortion pill they could die.
The findings add urgency to long-standing pro-life criticism of the FDA’s successive loosening of safeguards on mifepristone.
In an amicus brief joined by Sen. Bill Cassidy, R-La., and others, the senator criticized the Biden-era FDA.
“When looking at the full administrative record, it becomes clear that rather than letting science and evidence drive its decision making, the Biden FDA reached a predetermined and politically motivated conclusion to expand access to abortion drugs despite lacking enough evidence to show the change would be safe,” the brief stated.
Pro-life leaders have welcomed the new FDA study as a necessary step toward protecting women from what they describe as a dangerous drug whose risks have been minimized for years. The investigation comes amid ongoing litigation and congressional pressure to reinstate in-person requirements and other protections that were eliminated in the push for greater access.










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