
The U.S. Food and Drug Administration quietly approved a generic form of the chemical abortion drug mifepristone produced by a company that says its mission is to “normalize abortion,” a decision that pro-lifers have decried as a “betrayal.”
In a Tuesday letter to Evita Solutions LLC, the company that produces the drug, the FDA stated that it had conducted a review and determined that its mifepristone tablets are “bioequivalent and therapeutically equivalent” to the brand-name version, Mifeprex.
Pro-life advocates have condemned the decision, citing concerns about the loss of unborn lives and safety risks for women.
Responding to the backlash from pro-life groups, Secretary of Health and Human Services Robert F. Kennedy Jr., whose agency oversees the FDA, said in a statement on X Thursday that the FDA “only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”
Kennedy added that a review of the safety of the abortion pill is ongoing. The FDA's approval letter and Evita Solutions’ website both include links to information about the Risk Evaluation Mitigation Strategies.
In May, an Ethics and Public Policy Center analysis of 865,000 insurance claims found that 11% of women who took the abortion pills experienced “serious adverse events,” including hemorrhaging and infection.
Last month, National Right to Life released a report titled “Missed, Misclassified, and Minimized: Why Abortion Pill Complications Are Underreported.” The report attributed the reasons why chemical abortion complications are underreported or misreported to three factors: Women are often told to conceal any complications, a lack of curiousity from the media and the abortion industry masking side effects as “minor.”
Here are six reactions to the FDA’s approval of a generic form of the chemical abortion drug mifepristone.
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