The Food and Drug Administration granted approval for a second generic version of the abortion pill mifepristone, sparking outrage among anti-abortion conservatives, as it will likely increase the prevalence of medication abortions.

The FDA on Thursday approved the generic drug to be made by the telehealth abortion company Evita Solutions, according to a copy of the FDA approval letter obtained by the Washington Examiner.

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This marks the second approval of the abortion drug mifepristone, which was initially approved under the brand name Mifeprex in 2000 under the Clinton administration. Since then, mifepristone, along with the accompanying drug misoprostol, has become the most common abortion method in the United States.

Sen. Josh Hawley (R-MO), who has been pressing Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to conduct a safety review of mifepristone, said on X that the approval was “shocking.”

Mifepristone opponents have argued that the FDA’s decision in 2016 to no longer require physicians to report nonfatal adverse complications has led to skewed safety statistics for the drug. They also claim that removing in-person screening requirements for dispensing mifepristone puts women at risk, as an ultrasound is necessary to determine the gestational age of the fetus and rule out the risk of ectopic pregnancy.

A review of insurance claims data between 2017 and 2023, published by the anti-abortion Ethics and Public Policy Center this summer, found that nearly 11% of women prescribed mifepristone experience possibly life-threatening complications within 45 days of a medication abortion. 

Kennedy, during testimony before the Senate Finance Committee in September, assured Sen. James Lankford (R-OK) that the FDA was conducting a safety review of the drug, referencing the 11% complication statistic and saying the Biden administration “twisted the data to bury one of the safety signals.”

Hawley criticized the agency on Thursday following the new approval, saying it was ironic to approve a new version of mifepristone while reviewing the legitimacy of the compound’s safety data.

“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,” Hawley said on X. “I have lost confidence in the leadership at FDA.”

HHS spokesman Andrew Nixon told the Washington Examiner that the FDA “has very limited discretion in deciding whether to approve a generic drug.”

“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. Generic applicants are not required to submit independent evidence proving safety and effectiveness,” Nixon said.

He added that the department is currently “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.”

Marjorie Dannenfelser, president of the anti-abortion group SBA Pro-Life America, said the “reckless” and “unconscionable” new drug approval will only “flood the market with a cheap abortion drug.”

According to the Guttmacher Institute, an abortion-rights think tank, chemical abortions became significantly more prominent in the years following the approval of the GenBioPro generic version of the drug.

In 2017, only 39% of all abortions in the U.S. involved mifepristone and misoprostol protocols. That increased to 53% of all abortions in 2020 and 63% of the more than a million abortions in 2023.

There were several other intervening factors during that time that contributed to the increase, including the removal of in-person screening requirements before dispensing the pills, as well as abortion clinic closures in the wake of the overturning of Roe v. Wade.

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“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,” Dannenfelser said.

HHS did not respond to the Washington Examiner‘s request for comment.