The Food and Drug Administration (FDA) approved a new generic version of mifepristone on Tuesday.
Weeks after confirming a review of the abortion pill was underway, the FDA approved the application of a new mifepristone producer, Evita Solutions, LLC, according to a letter sent to the company.
“Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live,” the company’s website states. “We know that you can make the best choice for your body.”
The FDA has “very limited discretion in deciding whether to approve a generic drug,” HHS Communications Director Andrew Nixon told the Daily Caller News Foundation, adding that the agency “does not endorse any drug product and directs prescribers to follow all labeling.”
“By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Nixon said.
“Generic applicants are not required to submit independent evidence proving safety and effectiveness,” he continued. “HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
The company submitted its application in 2021, according to the approval letter.
“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said in a statement. “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.”
Evita Solutions did not immediately respond to a request for comment.
Republican Missouri Sen. Josh Hawley said he has “lost confidence in the leadership at FDA.”
“This is shocking,” Hawley wrote on X. “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.”
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. confirmed in a Sept. 19 letter to Republican attorneys general that the FDA is conducting “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
RFK. Jr also said during a hearing in September that the Biden administration “twisted the data to bury one of the safety signals” for mifepristone.
This is a breaking news story and will be updated.
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