The Federal Drug Administration (FDA) has approved a generic form of mifepristone. On Tuesday, the agency informed Evita Solutions that its drug application met required standards for approval. The medication now becomes the second generic version available in the market.
“The first, from pharmaceutical company GenBioPro, was approved in 2019,” the text noted.
“FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” Sen. Josh Hawley (R-MO) commented. “FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” he added.
Mifepristone is typically used with another pill, misoprostol, to induce abortions. Medication abortions account for nearly two-thirds of abortions in the U.S. The FDA stated in a letter to Evita Solutions on Tuesday, the day before the government shutdown began, that its mifepristone tablets were “therapeutically equivalent” to the brand-name version, Mifeprex, available since 2000.
Evita Solutions describes its mission as assisting “the medical community in recognizing the utility and freedom that medical abortion provides patients.” The company adds it seeks to normalize abortion care and make it accessible to all.
Pro-life groups criticized the FDA for the approval. Last week, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced the agency would consider modifying the Risk Evaluation and Mitigation Strategy requirements, citing “recent studies raising concerns about the safety of mifepristone as currently administered.”
This action drew outcry from anti-abortion conservative voices. Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony Pro-Life America, called the decision “unconscionable.” “These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,” said Dannenfelser, reiterating calls for the Trump administration to reverse the Biden administration’s changes allowing for abortion pills to be sent through the mail.