The Food and Drug Administration warned Monday that eliminating restrictions on abortion drugs, as 2020 presidential candidate Pete Buttigieg has suggested, could cause “serious complications” for women.
The South Bend mayor suggested ignoring the FDA’s Risk Evaluation and Mitigation Strategy (REMS) applied to the abortion drug mifepristone in a Nov. 25 survey conducted by the New York Times. REMS is an FDA drug safety program that the FDA requires “for certain medications with serious safety concerns.”
“Steps we can take in the interim to improve access to abortion include expanding access to abortion via telehealth, eliminating the Risk Evaluation and Mitigation Strategy (REMS) warning that ignores decades of evidence indicating that these medications are safe, and expanding the types of medical professionals able to prescribe them,” Buttigieg told the Times.
He also said that he would make mifepristone and misoprostol, another abortion drug, available over the counter.
But the FDA told the Daily Caller News Foundation Monday that REMS are put in place to “mitigate the risk of serious complications associated with mifepristone for medical termination of early pregnancy.”
The REMS program mitigates these risks by “requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone REMS Program; ensuring that mifepristone for medical termination of early pregnancy is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber; and informing patients about the risk of serious complications associated with mifepristone,” the FDA Office of Media Affairs told the DCNF.
The FDA Office of Media Affairs added that the REMS applied to mifepristone reflect the FDA’s conclusion “that certain distribution restrictions are necessary to ensure the safe use of the drug.”
Buttigieg’s campaign did not respond to multiple requests for comment from the DCNF.
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