51 senators ask FDA to rescind approval of new ‘generic’ abortion pill

Fifty-one senators asked the FDA to rescind its approval of a generic version of the abortion drug mifepristone on Oct. 9, 2025. / Credit: Yta23/Shutterstock

Washington, D.C. Newsroom, Oct 9, 2025 / 18:11 pm (CNA).

Nearly every Republican senator signed a letter Thursday urging the Food and Drug Administration (FDA) to reverse its decision to approve a “generic” version of the abortion pill mifepristone, which may come onto the market by January if no action is taken.

Sen. Lindsey Graham, joined by 50 of his colleagues, wrote that “we are deeply concerned” with the FDA’s decision. The FDA approved the generic mifepristone in late September without a public announcement.

In the letter, the senators wrote that the approval “appears inconsistent” with recent comments from Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who confirmed in early September that HHS is reviewing the safety of the abortion pill and said President Joe Biden’s administration “twisted the data” to downplay health concerns about the drug.

“Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market,” the senators wrote.

The letter urged the administration to “suspend the approval of any new generic versions of mifepristone” while the drug’s review is ongoing and “commit to ensuring that all generic versions of mifepristone are included in the ongoing reevaluation.”

The Republican senators also urged the FDA to reinstate safeguards that regulate the abortion pill, which includes an in-person dispensing requirement. The requirement was lifted under the Biden administration in 2021. Reinstating the requirement would prevent the drugs from being delivered through the mail. 

“These policies have enabled abortion pills to be obtained by abusers, traffickers, and even minors,” the senators argued.

“The aftermath has not only been deadly for preborn babies but lethal to their mothers,” the senators continued. “Contrary to the narrative peddled by the media that taking abortion pills is ‘safer than taking Tylenol,’ evidence shows that the risk of serious medical complications after taking mifepristone is at least 22 times higher than reported on the drug label. In fact, more than 1 in 10 women who take mifepristone will experience a serious adverse event.”

“We are committed to continuing to work together to give a voice to the voiceless and protect women from the dangerous effects of unregulated access to chemical abortion drugs,” they wrote. “The life, safety, freedom, and health of millions of Americans, born and unborn, depend on it.”